A Phase 4 interventional study of Atezolizumab in Carcinoma, Non-Small-Cell Lung, sponsored by Hoffmann-La Roche. Completed at 111 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
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Among 81 studies testing atezolizumab in Carcinoma, Non-Small-Cell Lung — 13 open to participants now, 27 under way, 5 of them phase 3. atezolizumab · Carcinoma, Non-Small-Cell Lung.
Among the 81 studies testing atezolizumab in Carcinoma, Non-Small-Cell Lung, this one is the 9th largest by enrollment, is one of 8 that started in 2017, is one of 3 in phase 4, and was the 28th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →13 of the 81 studies testing atezolizumab in Carcinoma, Non-Small-Cell Lung are open now, in 6 countries. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
Liza Villaruz, MD · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
EuroCityClinic LLC · Sites in Russia
Ages 18+
Fundación GECP · Sites in Spain
Ages 18+
By country, each count listing its studies:
atezolizumab: first FDA approval 2016 (TECENTRIQ), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, atezolizumab is the treatment under test here. Read study by study →
81 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 52 · Phase 3 19 · Phase 4 3
First in 2013; this study’s year is marked. 8 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 619 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 80 across the 81 interventional studies. Of the 47 that completed or were terminated, 30 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 81 have an industry lead sponsor. The 10 most frequent:
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
182 studies in Carcinoma, Non-Small-Cell Lung by Hoffmann-La Roche: 5 open now, 16 under way, 8 of them phase 3. Of 161 finished, 96 (60%) have results posted.
Among the 182 studies in Carcinoma, Non-Small-Cell Lung by Hoffmann-La Roche, this one is the 20th largest by enrollment of the 142 interventional ones that give a count, is one of 13 that started in 2017, is one of 10 in phase 4, and was the 134th registered.
Hoffmann-La Roche’s Carcinoma, Non-Small-Cell Lung studies by the year they started, since 2001.
10 of the studies testing atezolizumab in Carcinoma, Non-Small-Cell Lung that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03178552Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) | 2027-06-30 |
| NCT04302025Genentech, Inc.A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC) | 2026-11-30 |
| NCT03786692Fox Chase Cancer CenterPhase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC | 2026-12 |
| NCT04691817Abramson Cancer Center at Penn MedicineTocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy | 2026-12 |
| NCT05340309University of Southern CaliforniaSubcutaneous Atezolizumab for the Treatment of Non-small Cell Lung Cancer | 2026-12-31 |
Add all 10 to your calendar (.ics) → With an account.
Among the 81 studies testing atezolizumab in Carcinoma, Non-Small-Cell Lung, from their registry updates:
Among Hoffmann-La Roche’s 182 in Carcinoma, Non-Small-Cell Lung:
This tab as a report to print or save as PDF → With an account.
This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 [anti-PD-1] therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor [TKI] therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with Stage IIIb or State IV NSCLC who have progressed after standard systemic chemotherapy will receive atezolizumab until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
Drug: Atezolizumab
Participants will receive 1200 milligrams (mg) of atezolizumab administered by intravenous infusion on Day 1 of every 3-week cycle until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
Also known as: RO5541267, Tecentriq
Percentage of Participants With Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.
Time frame: Baseline up to 4 years
Percentage of Participants Alive 2 Years After Initiation of Treatment
The overall survival (OS) rate at 2 years, was defined as the percentage of participants remaining alive 2 years after initiation of study treatment.
Time frame: Baseline up to Year 2
Overall Survival (OS)
OS was defined as the time (in months) from initiation of study treatment to death from any cause.
Time frame: Baseline up to death (up to 4 years)
Progression-Free Survival (PFS) as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1)
PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to RECIST v1.1.
Time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire - Mobility Item
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a Visual Analogue Scale (VAS) that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the mobility item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.
Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
EQ-5D-5L Questionnaire - Self-Care Item
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the self-care item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.
Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
EQ-5D-5L Questionnaire - Usual Activities Item
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the usual activities item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.
Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
EQ-5D-5L Questionnaire - Pain/Discomfort Item
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the pain/discomfort item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.
Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
EQ-5D-5L Questionnaire - Anxiety/Depression Item
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the anxiety/depression item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.
Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
EQ-5D-5L Questionnaire - VAS Scores
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Values presented after baseline represent the change from baseline.
Time frame: Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years)
European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Supplemental Lung Cancer Module (EORTC QLQ-LC13)
The EORTC QLQ-LC13 consisted of 13 items that address key lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related adverse effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. The dysphagia scale is multi-item, while the rest are single-item scales. The scales are linearly transformed so that each score has a range from 0 to 100. A high scale score represents a higher response level (e.g. a high score for global health status represents a high QoL). A high score for the symptom scale represents a high level of symptoms. A \>=10-point change in the EORTC scale score was perceived by participants as clinically significant. Values presented after baseline represent the change from baseline.
Time frame: Day 1 of first 3 cycles (21-day cycle), then every 6 weeks for 48 weeks; thereafter every 9 weeks until disease progression or until treatment discontinuation (up to 4 years)
Progression-Free Survival as Evaluated By the Investigator in Accordance With Modified RECIST
PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to modified RECIST.
Time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
Percentage of Participants Alive 3 Years After Initiation of Treatment
The OS rate at 3 years, was defined as the percentage of participants remaining alive 3 years after initiation of study treatment.
Time frame: Baseline up to Year 3
Percentage of Participants With Objective Reponse as Assessed by the Investigator According to RECIST v1.1
Objective response rate (ORR), according to RECIST v1.1, was defined as the percentage of participants with a confirmed best overall response (BOR), either complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1.
Time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
Percentage of Participants With Objective Reponse as Assessed by the Investigator According to Modified RECIST
The investigator-assessed ORR was defined as the proportion of participants whose confirmed BOR is either a PR or CR per modified RECIST.
Time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
Duration of Response as Assessed by the Investigator According to RECIST v.1.1
DOR was defined as the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first reported) to documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first, among participants who had a best overall response as CR or PR.
Time frame: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)
Duration of Response as Assessed by the Investigator According to Modified RECIST
DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurred first.
Time frame: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)
Participants were enrolled at 111 sites across 24 countries.
| Milestone | Atezolizumab |
|---|---|
| Started | 615 |
| Completed | 13 |
| Not completed | 602 |
| Withdrew: Death | 470 |
| Withdrew: Lost to follow-up | 18 |
| Withdrew: Physician decision | 2 |
| Withdrew: Study terminated by sponsor | 79 |
| Withdrew: Withdrawal by subject | 33 |
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.
| Participants | Atezolizumab |
|---|---|
| Percentage of Participants With Adverse Events | 564 |
The overall survival (OS) rate at 2 years, was defined as the percentage of participants remaining alive 2 years after initiation of study treatment.
| Percentage of Participants | Atezolizumab |
|---|---|
| Percentage of Participants Alive 2 Years After Initiation of Treatment | 26.7 |
OS was defined as the time (in months) from initiation of study treatment to death from any cause.
| Months | Atezolizumab |
|---|---|
| Overall Survival (OS) | 11.2 (8.9 to 12.7) |
PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to RECIST v1.1.
| Months | Atezolizumab |
|---|---|
| Progression-Free Survival (PFS) as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1) | 2.7 (2.3 to 2.8) |
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a Visual Analogue Scale (VAS) that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the mobility item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.
| Participants | Atezolizumab |
|---|---|
| Baseline: No Problem | 328 |
| Baseline: Slight Problem | 146 |
| Baseline: Moderate Problems | 97 |
| Baseline: Severe Problems | 24 |
| Baseline: Extreme Problems | 1 |
| Baseline: Invalid Response | 1 |
| Cycle 2 Day 1: No Problem | 274 |
| Cycle 2 Day 1: Slight Problems | 145 |
| Cycle 2 Day 1: Moderate Problems | 84 |
| Cycle 2 Day 1: Severe Problems | 26 |
| Cycle 2 Day 1: Extreme Problems | 4 |
| Cycle 2 Day 1: Invalid Response | 1 |
| Tumor Assessment Week 006: No Problem | 229 |
| Tumor Assessment Week 006: Slight Problems | 121 |
| Tumor Assessment Week 006: Moderate Problems | 69 |
| Tumor Assessment Week 006: Severe Problems | 16 |
| Tumor Assessment Week 006: Extreme Problems | 3 |
| Tumor Assessment Week 012: No Problem | 183 |
| Tumor Assessment Week 012: Slight Problems | 75 |
| Tumor Assessment Week 012: Moderate Problems | 48 |
| Tumor Assessment Week 012: Severe Problems | 10 |
| Tumor Assessment Week 012: Extreme Problems | 5 |
| Tumor Assessment Week 012: Invalid Response | 2 |
| Tumor Assessment Week 018: No Problem | 153 |
| Tumor Assessment Week 018: Slight Problems | 66 |
| Tumor Assessment Week 018: Moderate Problems | 27 |
| Tumor Assessment Week 018: Severe Problems | 11 |
| Tumor Assessment Week 018: Extreme Problems | 3 |
| Tumor Assessment Week 024: No Problem | 131 |
| Tumor Assessment Week 024: Slight Problems | 56 |
| Tumor Assessment Week 024: Moderate Problems | 22 |
| Tumor Assessment Week 024: Severe Problems | 4 |
| Tumor Assessment Week 024: Extreme Problems | 4 |
| Tumor Assessment Week 024: Invalid Response | 3 |
| Tumor Assessment Week 030: No Problem | 124 |
| Tumor Assessment Week 030: Slight Problems | 41 |
| Tumor Assessment Week 030: Moderate Problems | 14 |
| Tumor Assessment Week 030: Severe Problems | 4 |
| Tumor Assessment Week 030: Extreme Problems | 1 |
| Tumor Assessment Week 036: No Problem | 110 |
| Tumor Assessment Week 036: Slight Problems | 31 |
| Tumor Assessment Week 036: Moderate Problems | 20 |
| Tumor Assessment Week 036: Severe Problems | 1 |
| Tumor Assessment Week 042: No Problem | 88 |
| Tumor Assessment Week 042: Slight Problems | 39 |
| Tumor Assessment Week 042: Moderate Problems | 14 |
| Tumor Assessment Week 042: Severe Problems | 4 |
| Tumor Assessment Week 048: No Problem | 75 |
| Tumor Assessment Week 048: Slight Problems | 32 |
| Tumor Assessment Week 048: Moderate Problems | 16 |
| Tumor Assessment Week 048: Severe Problems | 3 |
| Tumor Assessment Week 048: Extreme Problems | 1 |
| Tumor Assessment Week 054: No Problem | 11 |
| Tumor Assessment Week 054: Slight Problems | 6 |
| Tumor Assessment Week 054: Moderate Problems | 5 |
| Tumor Assessment Week 054: Severe Problems | 1 |
| Tumor Assessment Week 057: No Problem | 64 |
| Tumor Assessment Week 057: Slight Problems | 20 |
| Tumor Assessment Week 057: Moderate Problems | 8 |
| Tumor Assessment Week 057: Severe Problems | 3 |
| Tumor Assessment Week 057: Extreme Problems | 2 |
| Tumor Assessment Week 060: No Problem | 10 |
| Tumor Assessment Week 060: Slight Problems | 3 |
| Tumor Assessment Week 060: Moderate Problems | 3 |
| Tumor Assessment Week 060: Extreme Problems | 1 |
| Tumor Assessment Week 066: No Problem | 56 |
| Tumor Assessment Week 066: Slight Problems | 20 |
| Tumor Assessment Week 066: Moderate Problems | 9 |
| Tumor Assessment Week 066: Severe Problems | 2 |
| Tumor Assessment Week 066: Extreme Problems | 1 |
| Tumor Assessment Week 072: No Problem | 7 |
| Tumor Assessment Week 072: Slight Problems | 4 |
| Tumor Assessment Week 072: Moderate Problems | 2 |
| Tumor Assessment Week 075: No Problem | 45 |
| Tumor Assessment Week 075: Slight Problems | 20 |
| Tumor Assessment Week 075: Moderate Problems | 7 |
| Tumor Assessment Week 075: Severe Problems | 1 |
| Tumor Assessment Week 078: No Problem | 6 |
| Tumor Assessment Week 078: Slight Problems | 3 |
| Tumor Assessment Week 078: Severe Problems | 1 |
| Tumor Assessment Week 084: No Problem | 47 |
| Tumor Assessment Week 084: Slight Problems | 12 |
| Tumor Assessment Week 084: Moderate Problems | 6 |
| Tumor Assessment Week 084: Severe Problems | 2 |
| Tumor Assessment Week 090: No Problem | 7 |
| Tumor Assessment Week 090: Slight Problems | 2 |
| Tumor Assessment Week 090: Moderate Problems | 1 |
| Tumor Assessment Week 093: No Problem | 34 |
| Tumor Assessment Week 093: Slight Problems | 16 |
| Tumor Assessment Week 093: Moderate Problems | 2 |
| Tumor Assessment Week 093: Extreme Problems | 1 |
| Tumor Assessment Week 096: No Problem | 4 |
| Tumor Assessment Week 096: Slight Problems | 2 |
| Tumor Assessment Week 096: Severe Problems | 1 |
| Tumor Assessment Week 102: No Problem | 33 |
| Tumor Assessment Week 102: Slight Problems | 16 |
| Tumor Assessment Week 102: Moderate Problems | 4 |
| Tumor Assessment Week 102: Severe Problems | 1 |
| Tumor Assessment Week 102: Extreme Problems | 1 |
| Tumor Assessment Week 108: No Problem | 3 |
| Tumor Assessment Week 108: Slight Problems | 3 |
| Tumor Assessment Week 108: Moderate Problems | 1 |
| Tumor Assessment Week 111: No Problem | 25 |
| Tumor Assessment Week 111: Slight Problems | 13 |
| Tumor Assessment Week 111: Moderate Problems | 2 |
| Tumor Assessment Week 111: Severe Problems | 1 |
| Tumor Assessment Week 114: Slight Problems | 1 |
| Tumor Assessment Week 114: Moderate Problems | 1 |
| Tumor Assessment Week 120: No Problem | 22 |
| Tumor Assessment Week 120: Slight Problems | 14 |
| Tumor Assessment Week 120: Moderate Problems | 1 |
| Tumor Assessment Week 120: Extreme Problems | 1 |
| Tumor Assessment Week 126: No Problem | 1 |
| Tumor Assessment Week 126: Slight Problems | 3 |
| Tumor Assessment Week 129: No Problem | 19 |
| Tumor Assessment Week 129: Slight Problems | 11 |
| Tumor Assessment Week 129: Moderate Problems | 1 |
| Tumor Assessment Week 129: Severe Problems | 1 |
| Tumor Assessment Week 132: No Problem | 1 |
| Tumor Assessment Week 132: Slight Problems | 1 |
| Tumor Assessment Week 138: No Problem | 17 |
| Tumor Assessment Week 138: Slight Problems | 10 |
| Tumor Assessment Week 138: Extreme Problems | 1 |
| Tumor Assessment Week 144: No Problem | 1 |
| Tumor Assessment Week 147: No Problem | 14 |
| Tumor Assessment Week 147: Slight Problems | 6 |
| Tumor Assessment Week 147: Severe Problems | 1 |
| Tumor Assessment Week 156: No Problem | 8 |
| Tumor Assessment Week 156: Slight Problems | 5 |
| Tumor Assessment Week 156: Moderate Problems | 1 |
| Tumor Assessment Week 156: Severe Problems | 1 |
| Tumor Assessment Week 165: No Problem | 3 |
| Tumor Assessment Week 165: Slight Problems | 8 |
| Tumor Assessment Week 165: Severe Problems | 1 |
| Tumor Assessment Week 165: Invalid Response | 1 |
| Tumor Assessment Week 174: No Problem | 6 |
| Tumor Assessment Week 174: Slight Problems | 4 |
| Tumor Assessment Week 183: Slight Problems | 3 |
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the self-care item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.
| Participants | Atezolizumab |
|---|---|
| Baseline: No Problem | 475 |
| Baseline: Slight Problem | 66 |
| Baseline: Moderate Problems | 44 |
| Baseline: Severe Problems | 8 |
| Baseline: Extreme Problems | 4 |
| Baseline: Invalid Response | 1 |
| Cycle 2 Day 1: No Problem | 402 |
| Cycle 2 Day 1: Slight Problems | 79 |
| Cycle 2 Day 1: Moderate | 37 |
| Cycle 2 Day 1: Severe Problems | 10 |
| Cycle 2 Day 1: Extreme Problems | 5 |
| Cycle 2 Day 1: Invalid Response | 1 |
| Tumor Assessment Week 006: No Problem | 327 |
| Tumor Assessment Week 006: Slight Problems | 67 |
| Tumor Assessment Week 006: Moderate Problems | 33 |
| Tumor Assessment Week 006: Severe Problems | 6 |
| Tumor Assessment Week 006: Extreme Problems | 5 |
| Tumor Assessment Week 012: No Problem | 245 |
| Tumor Assessment Week 012: Slight Problems | 47 |
| Tumor Assessment Week 012: Moderate Problems | 20 |
| Tumor Assessment Week 012: Severe Problems | 5 |
| Tumor Assessment Week 012: Extreme Problems | 5 |
| Tumor Assessment Week 018: No Problem | 205 |
| Tumor Assessment Week 018: Slight Problems | 35 |
| Tumor Assessment Week 018: Moderate Problems | 16 |
| Tumor Assessment Week 018: Severe Problems | 2 |
| Tumor Assessment Week 018: Extreme Problems | 2 |
| Tumor Assessment Week 024: No Problem | 174 |
| Tumor Assessment Week 024: Slight Problems | 35 |
| Tumor Assessment Week 024: Moderate Problems | 5 |
| Tumor Assessment Week 024: Severe Problems | 1 |
| Tumor Assessment Week 024: Extreme Problems | 2 |
| Tumor Assessment Week 024: Invalid Response | 3 |
| Tumor Assessment Week 030: No Problem | 150 |
| Tumor Assessment Week 030: Slight Problems | 26 |
| Tumor Assessment Week 030: Moderate Problems | 7 |
| Tumor Assessment Week 030: Extreme Problems | 1 |
| Tumor Assessment Week 036: No Problem | 129 |
| Tumor Assessment Week 036: Slight Problems | 24 |
| Tumor Assessment Week 036: Moderate Problems | 9 |
| Tumor Assessment Week 042: No Problem | 113 |
| Tumor Assessment Week 042: Slight Problems | 23 |
| Tumor Assessment Week 042: Moderate Problems | 9 |
| Tumor Assessment Week 048: No Problem | 99 |
| Tumor Assessment Week 048: Slight Problems | 18 |
| Tumor Assessment Week 048: Moderate Problems | 8 |
| Tumor Assessment Week 048: Severe Problems | 2 |
| Tumor Assessment Week 054: No Problem | 15 |
| Tumor Assessment Week 054: Slight Problems | 5 |
| Tumor Assessment Week 054: Moderate Problems | 3 |
| Tumor Assessment Week 057: No Problem | 78 |
| Tumor Assessment Week 057: Slight Problems | 12 |
| Tumor Assessment Week 057: Moderate Problems | 5 |
| Tumor Assessment Week 057: Extreme Problems | 1 |
| Tumor Assessment Week 060: No Problem | 12 |
| Tumor Assessment Week 060: Slight Problems | 4 |
| Tumor Assessment Week 060: Moderate Problems | 1 |
| Tumor Assessment Week 066: No Problem | 69 |
| Tumor Assessment Week 066: Slight Problems | 14 |
| Tumor Assessment Week 066: Moderate Problems | 5 |
| Tumor Assessment Week 072: No Problem | 10 |
| Tumor Assessment Week 072: Slight Problems | 3 |
| Tumor Assessment Week 075: No Problem | 57 |
| Tumor Assessment Week 075: Slight Problems | 14 |
| Tumor Assessment Week 075: Moderate Problems | 1 |
| Tumor Assessment Week 075: Extreme Problems | 1 |
| Tumor Assessment Week 078: No Problem | 7 |
| Tumor Assessment Week 078: Slight Problems | 2 |
| Tumor Assessment Week 078: Severe Problems | 1 |
| Tumor Assessment Week 084: No Problem | 51 |
| Tumor Assessment Week 084: Slight Problems | 12 |
| Tumor Assessment Week 084: Moderate Problems | 3 |
| Tumor Assessment Week 084: Severe Problems | 1 |
| Tumor Assessment Week 090: No Problem | 6 |
| Tumor Assessment Week 090: Slight Problems | 3 |
| Tumor Assessment Week 090: Severe Problems | 1 |
| Tumor Assessment Week 093: No Problem | 44 |
| Tumor Assessment Week 093: Slight Problems | 7 |
| Tumor Assessment Week 093: Severe Problems | 1 |
| Tumor Assessment Week 093: Extreme Problems | 1 |
| Tumor Assessment Week 096: No Problem | 4 |
| Tumor Assessment Week 096: Slight Problems | 2 |
| Tumor Assessment Week 096: Severe Problems | 1 |
| Tumor Assessment Week 102: No Problem | 45 |
| Tumor Assessment Week 102: Slight Problems | 7 |
| Tumor Assessment Week 102: Moderate Problems | 1 |
| Tumor Assessment Week 102: Severe Problems | 1 |
| Tumor Assessment Week 102: Extreme Problems | 1 |
| Tumor Assessment Week 108: No Problem | 3 |
| Tumor Assessment Week 108: Slight Problems | 4 |
| Tumor Assessment Week 111: No Problem | 33 |
| Tumor Assessment Week 111: Slight Problems | 7 |
| Tumor Assessment Week 111: Extreme Problems | 1 |
| Tumor Assessment Week 114: Slight Problems | 1 |
| Tumor Assessment Week 114: Moderate Problems | 1 |
| Tumor Assessment Week 120: No Problem | 30 |
| Tumor Assessment Week 120: Slight Problems | 7 |
| Tumor Assessment Week 120: Moderate Problems | 1 |
| Tumor Assessment Week 126: No Problem | 1 |
| Tumor Assessment Week 126: Slight Problems | 3 |
| Tumor Assessment Week 129: No Problem | 26 |
| Tumor Assessment Week 129: Slight Problems | 5 |
| Tumor Assessment Week 129: Extreme Problems | 1 |
| Tumor Assessment Week 132: No Problem | 1 |
| Tumor Assessment Week 132: Slight Problems | 1 |
| Tumor Assessment Week 138: No Problem | 23 |
| Tumor Assessment Week 138: Slight Problems | 5 |
| Tumor Assessment Week 144: No Problem | 1 |
| Tumor Assessment Week 147: No Problem | 19 |
| Tumor Assessment Week 147: Slight Problems | 2 |
| Tumor Assessment Week 156: No Problem | 11 |
| Tumor Assessment Week 156: Slight Problems | 4 |
| Tumor Assessment Week 165: No Problem | 10 |
| Tumor Assessment Week 165: Slight Problems | 1 |
| Tumor Assessment Week 165: Moderate Problems | 1 |
| Tumor Assessment Week 165: Invalid Response | 1 |
| Tumor Assessment Week 174: No Problem | 9 |
| Tumor Assessment Week 174: Slight Problems | 1 |
| Tumor Assessment Week 183: No Problem | 1 |
| Tumor Assessment Week 183: Slight Problems | 2 |
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the usual activities item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.
| Participants | Atezolizumab |
|---|---|
| Baseline: No Problem | 297 |
| Baseline: Slight Problem | 164 |
| Baseline: Moderate Problems | 99 |
| Baseline: Severe Problems | 16 |
| Baseline: Extreme Problems | 21 |
| Cycle 2 Day 1: No Problem | 257 |
| Cycle 2 Day 1: Slight Problems | 152 |
| Cycle 2 Day 1: Moderate Problems | 85 |
| Cycle 2 Day 1: Severe Problems | 24 |
| Cycle 2 Day 1: Extreme Problems | 16 |
| Tumor Assessment Week 006: No Problem | 221 |
| Tumor Assessment Week 006: Slight Problems | 121 |
| Tumor Assessment Week 006: Moderate Problems | 69 |
| Tumor Assessment Week 006: Severe Problems | 14 |
| Tumor Assessment Week 006: Extreme Problems | 13 |
| Tumor Assessment Week 012: No Problem | 175 |
| Tumor Assessment Week 012: Slight Problems | 83 |
| Tumor Assessment Week 012: Moderate Problems | 47 |
| Tumor Assessment Week 012: Severe Problems | 10 |
| Tumor Assessment Week 012: Extreme Problems | 8 |
| Tumor Assessment Week 018: No Problem | 143 |
| Tumor Assessment Week 018: Slight Problems | 80 |
| Tumor Assessment Week 018: Moderate Problems | 29 |
| Tumor Assessment Week 018: Severe Problems | 3 |
| Tumor Assessment Week 018: Extreme Problems | 5 |
| Tumor Assessment Week 024: No Problem | 134 |
| Tumor Assessment Week 024: Slight Problems | 56 |
| Tumor Assessment Week 024: Moderate Problems | 22 |
| Tumor Assessment Week 024: Severe Problems | 1 |
| Tumor Assessment Week 024: Extreme Problems | 6 |
| Tumor Assessment Week 024: Invalid Response | 1 |
| Tumor Assessment Week 030: No Problem | 124 |
| Tumor Assessment Week 030: Slight Problems | 43 |
| Tumor Assessment Week 030: Moderate Problems | 9 |
| Tumor Assessment Week 030: Severe Problems | 5 |
| Tumor Assessment Week 030: Extreme Problems | 3 |
| Tumor Assessment Week 036: No Problem | 107 |
| Tumor Assessment Week 036: Slight Problems | 38 |
| Tumor Assessment Week 036: Moderate Problems | 13 |
| Tumor Assessment Week 036: Severe Problems | 3 |
| Tumor Assessment Week 036: Extreme Problems | 1 |
| Tumor Assessment Week 042: No Problem | 97 |
| Tumor Assessment Week 042: Slight Problems | 32 |
| Tumor Assessment Week 042: Moderate Problems | 11 |
| Tumor Assessment Week 042: Severe Problems | 3 |
| Tumor Assessment Week 042: Extreme Problems | 2 |
| Tumor Assessment Week 048: No Problem | 81 |
| Tumor Assessment Week 048: Slight Problems | 31 |
| Tumor Assessment Week 048: Moderate Problems | 8 |
| Tumor Assessment Week 048: Severe Problems | 5 |
| Tumor Assessment Week 048: Extreme Problems | 1 |
| Tumor Assessment Week 048: Invalid Response | 1 |
| Tumor Assessment Week 054: No Problem | 10 |
| Tumor Assessment Week 054: Slight Problems | 8 |
| Tumor Assessment Week 054: Moderate Problems | 3 |
| Tumor Assessment Week 054: Severe Problems | 1 |
| Tumor Assessment Week 054: Extreme Problems | 1 |
| Tumor Assessment Week 057: No Problem | 61 |
| Tumor Assessment Week 057: Slight Problems | 23 |
| Tumor Assessment Week 057: Moderate Problems | 7 |
| Tumor Assessment Week 057: Severe Problems | 1 |
| Tumor Assessment Week 057: Extreme Problems | 4 |
| Tumor Assessment Week 057: Invalid Response | 1 |
| Tumor Assessment Week 060: No Problem | 12 |
| Tumor Assessment Week 060: Slight Problems | 3 |
| Tumor Assessment Week 060: Moderate Problems | 1 |
| Tumor Assessment Week 060: Extreme Problems | 1 |
| Tumor Assessment Week 066: No Problem | 58 |
| Tumor Assessment Week 066: Slight Problems | 19 |
| Tumor Assessment Week 066: Moderate Problems | 7 |
| Tumor Assessment Week 066: Severe Problems | 4 |
| Tumor Assessment Week 072: No Problem | 7 |
| Tumor Assessment Week 072: Slight Problems | 4 |
| Tumor Assessment Week 072: Moderate Problems | 1 |
| Tumor Assessment Week 072: Severe Problems | 1 |
| Tumor Assessment Week 075: No Problem | 47 |
| Tumor Assessment Week 075: Slight Problems | 21 |
| Tumor Assessment Week 075: Moderate Problems | 5 |
| Tumor Assessment Week 078: No Problem | 6 |
| Tumor Assessment Week 078: Slight Problems | 2 |
| Tumor Assessment Week 078: Moderate Problems | 1 |
| Tumor Assessment Week 078: Severe Problems | 1 |
| Tumor Assessment Week 084: No Problem | 46 |
| Tumor Assessment Week 084: Slight Problems | 12 |
| Tumor Assessment Week 084: Moderate Problems | 6 |
| Tumor Assessment Week 084: Severe Problems | 1 |
| Tumor Assessment Week 084: Extreme Problems | 2 |
| Tumor Assessment Week 090: No Problem | 6 |
| Tumor Assessment Week 090: Slight Problems | 3 |
| Tumor Assessment Week 090: Severe Problems | 1 |
| Tumor Assessment Week 093: No Problem | 36 |
| Tumor Assessment Week 093: Slight Problems | 12 |
| Tumor Assessment Week 093: Moderate Problems | 4 |
| Tumor Assessment Week 093: Extreme Problems | 1 |
| Tumor Assessment Week 096: No Problem | 5 |
| Tumor Assessment Week 096: Slight Problems | 1 |
| Tumor Assessment Week 096: Severe Problems | 1 |
| Tumor Assessment Week 102: No Problem | 36 |
| Tumor Assessment Week 102: Slight Problems | 13 |
| Tumor Assessment Week 102: Moderate Problems | 3 |
| Tumor Assessment Week 102: Severe Problems | 2 |
| Tumor Assessment Week 102: Extreme Problems | 1 |
| Tumor Assessment Week 108: No Problem | 3 |
| Tumor Assessment Week 108: Slight Problems | 4 |
| Tumor Assessment Week 111: No Problem | 25 |
| Tumor Assessment Week 111: Slight Problems | 12 |
| Tumor Assessment Week 111: Moderate Problems | 3 |
| Tumor Assessment Week 111: Extreme Problems | 1 |
| Tumor Assessment Week 114: Slight Problems | 1 |
| Tumor Assessment Week 114: Moderate Problems | 1 |
| Tumor Assessment Week 120: No Problem | 27 |
| Tumor Assessment Week 120: Slight Problems | 10 |
| Tumor Assessment Week 120: Extreme Problems | 1 |
| Tumor Assessment Week 126: No Problem | 1 |
| Tumor Assessment Week 126: Slight Problems | 3 |
| Tumor Assessment Week 129: No Problem | 22 |
| Tumor Assessment Week 129: Slight Problems | 9 |
| Tumor Assessment Week 129: Extreme Problems | 1 |
| Tumor Assessment Week 132: No Problem | 1 |
| Tumor Assessment Week 132: Moderate Problems | 1 |
| Tumor Assessment Week 138: No Problem | 16 |
| Tumor Assessment Week 138: Slight Problems | 10 |
| Tumor Assessment Week 138: Moderate Problems | 2 |
| Tumor Assessment Week 144: No Problem | 1 |
| Tumor Assessment Week 147: No Problem | 12 |
| Tumor Assessment Week 147: Slight Problems | 7 |
| Tumor Assessment Week 147: Moderate Problems | 2 |
| Tumor Assessment Week 156: No Problem | 9 |
| Tumor Assessment Week 156: Slight Problems | 5 |
| Tumor Assessment Week 156: Extreme Problems | 1 |
| Tumor Assessment Week 165: No Problem | 6 |
| Tumor Assessment Week 165: Slight Problems | 4 |
| Tumor Assessment Week 165: Moderate Problems | 1 |
| Tumor Assessment Week 165: Extreme Problems | 1 |
| Tumor Assessment Week 165: Invalid Response | 1 |
| Tumor Assessment Week 174: No Problem | 8 |
| Tumor Assessment Week 174: Slight Problems | 2 |
| Tumor Assessment Week 183: Slight Problems | 3 |
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the pain/discomfort item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.
| Participants | Atezolizumab |
|---|---|
| Baseline: No Problem | 206 |
| Baseline: Slight Problem | 216 |
| Baseline: Moderate Problems | 129 |
| Baseline: Severe Problems | 38 |
| Baseline: Extreme Problems | 7 |
| Baseline: Invalid Response | 1 |
| Cycle 2 Day 1: No Problem | 212 |
| Cycle 2 Day 1: Slight Problems | 165 |
| Cycle 2 Day 1: Moderate Problems | 117 |
| Cycle 2 Day 1: Severe Problems | 34 |
| Cycle 2 Day 1: Extreme Problems | 6 |
| Tumor Assessment Week 006: No Problem | 165 |
| Tumor Assessment Week 006: Slight Problems | 143 |
| Tumor Assessment Week 006: Moderate Problems | 93 |
| Tumor Assessment Week 006: Severe Problems | 31 |
| Tumor Assessment Week 006: Extreme Problems | 5 |
| Tumor Assessment Week 012: No Problem | 125 |
| Tumor Assessment Week 012: Slight Problems | 116 |
| Tumor Assessment Week 012: Moderate Problems | 61 |
| Tumor Assessment Week 012: Severe Problems | 16 |
| Tumor Assessment Week 012: Extreme Problems | 4 |
| Tumor Assessment Week 018: No Problem | 123 |
| Tumor Assessment Week 018: Slight Problems | 88 |
| Tumor Assessment Week 018: Moderate Problems | 32 |
| Tumor Assessment Week 018: Severe Problems | 15 |
| Tumor Assessment Week 018: Extreme Problems | 1 |
| Tumor Assessment Week 018: Invalid Response | 1 |
| Tumor Assessment Week 024: No Problem | 101 |
| Tumor Assessment Week 024: Slight Problems | 74 |
| Tumor Assessment Week 024: Moderate Problems | 33 |
| Tumor Assessment Week 024: Severe Problems | 10 |
| Tumor Assessment Week 024: Extreme Problems | 1 |
| Tumor Assessment Week 024: Invalid Response | 1 |
| Tumor Assessment Week 030: No Problem | 89 |
| Tumor Assessment Week 030: Slight Problems | 64 |
| Tumor Assessment Week 030: Moderate Problems | 25 |
| Tumor Assessment Week 030: Severe Problems | 6 |
| Tumor Assessment Week 036: No Problem | 85 |
| Tumor Assessment Week 036: Slight Problems | 51 |
| Tumor Assessment Week 036: Moderate Problems | 19 |
| Tumor Assessment Week 036: Severe Problems | 6 |
| Tumor Assessment Week 036: Extreme Problems | 1 |
| Tumor Assessment Week 042: No Problem | 68 |
| Tumor Assessment Week 042: Slight Problems | 51 |
| Tumor Assessment Week 042: Moderate Problems | 19 |
| Tumor Assessment Week 042: Severe Problems | 6 |
| Tumor Assessment Week 042: Extreme Problems | 1 |
| Tumor Assessment Week 048: No Problem | 64 |
| Tumor Assessment Week 048: Slight Problems | 41 |
| Tumor Assessment Week 048: Moderate Problems | 15 |
| Tumor Assessment Week 048: Severe Problems | 5 |
| Tumor Assessment Week 048: Extreme Problems | 2 |
| Tumor Assessment Week 054: No Problem | 9 |
| Tumor Assessment Week 054: Slight Problems | 10 |
| Tumor Assessment Week 054: Moderate Problems | 4 |
| Tumor Assessment Week 057: No Problem | 53 |
| Tumor Assessment Week 057: Slight Problems | 27 |
| Tumor Assessment Week 057: Moderate Problems | 12 |
| Tumor Assessment Week 057: Severe Problems | 5 |
| Tumor Assessment Week 060: No Problem | 12 |
| Tumor Assessment Week 060: Slight Problems | 3 |
| Tumor Assessment Week 060: Moderate Problems | 2 |
| Tumor Assessment Week 066: No Problem | 48 |
| Tumor Assessment Week 066: Slight Problems | 27 |
| Tumor Assessment Week 066: Moderate Problems | 8 |
| Tumor Assessment Week 066: Severe Problems | 5 |
| Tumor Assessment Week 072: No Problem | 7 |
| Tumor Assessment Week 072: Slight Problems | 5 |
| Tumor Assessment Week 072: Moderate Problems | 1 |
| Tumor Assessment Week 075: No Problem | 45 |
| Tumor Assessment Week 075: Slight Problems | 19 |
| Tumor Assessment Week 075: Moderate Problems | 8 |
| Tumor Assessment Week 075: Extreme Problems | 1 |
| Tumor Assessment Week 078: No Problem | 6 |
| Tumor Assessment Week 078: Slight Problems | 3 |
| Tumor Assessment Week 078: Severe Problems | 1 |
| Tumor Assessment Week 084: No Problem | 41 |
| Tumor Assessment Week 084: Slight Problems | 18 |
| Tumor Assessment Week 084: Moderate Problems | 5 |
| Tumor Assessment Week 084: Severe Problems | 3 |
| Tumor Assessment Week 090: No Problem | 8 |
| Tumor Assessment Week 090: Slight Problems | 1 |
| Tumor Assessment Week 090: Severe Problems | 1 |
| Tumor Assessment Week 093: No Problem | 34 |
| Tumor Assessment Week 093: Slight Problems | 14 |
| Tumor Assessment Week 093: Moderate Problems | 2 |
| Tumor Assessment Week 093: Severe Problems | 3 |
| Tumor Assessment Week 096: No Problem | 4 |
| Tumor Assessment Week 096: Slight Problems | 2 |
| Tumor Assessment Week 096: Severe Problems | 1 |
| Tumor Assessment Week 102: No Problem | 33 |
| Tumor Assessment Week 102: Slight Problems | 16 |
| Tumor Assessment Week 102: Moderate Problems | 4 |
| Tumor Assessment Week 102: Severe Problems | 2 |
| Tumor Assessment Week 108: No Problem | 4 |
| Tumor Assessment Week 108: Slight Problems | 3 |
| Tumor Assessment Week 111: No Problem | 21 |
| Tumor Assessment Week 111: Slight Problems | 17 |
| Tumor Assessment Week 111: Moderate Problems | 2 |
| Tumor Assessment Week 111: Extreme Problems | 1 |
| Tumor Assessment Week 114: Slight Problems | 1 |
| Tumor Assessment Week 114: Moderate Problems | 1 |
| Tumor Assessment Week 120: No Problem | 20 |
| Tumor Assessment Week 120: Slight Problems | 14 |
| Tumor Assessment Week 120: Moderate Problems | 4 |
| Tumor Assessment Week 126: No Problem | 1 |
| Tumor Assessment Week 126: Slight Problems | 3 |
| Tumor Assessment Week 129: No Problem | 17 |
| Tumor Assessment Week 129: Slight Problems | 13 |
| Tumor Assessment Week 129: Moderate Problems | 1 |
| Tumor Assessment Week 129: Severe Problems | 1 |
| Tumor Assessment Week 132: No Problem | 1 |
| Tumor Assessment Week 132: Slight Problems | 1 |
| Tumor Assessment Week 138: No Problem | 15 |
| Tumor Assessment Week 138: Slight Problems | 10 |
| Tumor Assessment Week 138: Moderate Problems | 2 |
| Tumor Assessment Week 138: Severe Problems | 1 |
| Tumor Assessment Week 144: No Problem | 1 |
| Tumor Assessment Week 147: No Problem | 11 |
| Tumor Assessment Week 147: Slight Problems | 8 |
| Tumor Assessment Week 147: Moderate Problems | 2 |
| Tumor Assessment Week 156: No Problem | 8 |
| Tumor Assessment Week 156: Slight Problems | 4 |
| Tumor Assessment Week 156: Moderate Problems | 3 |
| Tumor Assessment Week 165: No Problem | 4 |
| Tumor Assessment Week 165: Slight Problems | 5 |
| Tumor Assessment Week 165: Moderate Problems | 2 |
| Tumor Assessment Week 165: Severe Problems | 1 |
| Tumor Assessment Week 165: Invalid Response | 1 |
| Tumor Assessment Week 174: No Problem | 5 |
| Tumor Assessment Week 174: Slight Problems | 3 |
| Tumor Assessment Week 174: Moderate Problems | 2 |
| Tumor Assessment Week 183: Slight Problems | 2 |
| Tumor Assessment Week 183: Moderate Problems | 1 |
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the anxiety/depression item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.
| Participants | Atezolizumab |
|---|---|
| Baseline: No Problem | 334 |
| Baseline: Slight Problem | 163 |
| Baseline: Moderate Problems | 83 |
| Baseline: Severe Problems | 13 |
| Baseline: Extreme Problems | 3 |
| Baseline: Invalid Response | 1 |
| Cycle 2 Day 1: No Problem | 296 |
| Cycle 2 Day 1: Slight Problems | 157 |
| Cycle 2 Day 1: Moderate Problems | 66 |
| Cycle 2 Day 1: Severe Problems | 9 |
| Cycle 2 Day 1: Extreme Problems | 4 |
| Cycle 2 Day 1: Invalid Response | 2 |
| Tumor Assessment Week 006: No Problem | 267 |
| Tumor Assessment Week 006: Slight Problems | 109 |
| Tumor Assessment Week 006: Moderate Problems | 49 |
| Tumor Assessment Week 006: Severe Problems | 10 |
| Tumor Assessment Week 006: Extreme Problems | 2 |
| Tumor Assessment Week 012: No Problem | 190 |
| Tumor Assessment Week 012: Slight Problems | 102 |
| Tumor Assessment Week 012: Moderate Problems | 20 |
| Tumor Assessment Week 012: Severe Problems | 8 |
| Tumor Assessment Week 012: Extreme Problems | 2 |
| Tumor Assessment Week 018: No Problem | 167 |
| Tumor Assessment Week 018: Slight Problems | 66 |
| Tumor Assessment Week 018: Moderate Problems | 22 |
| Tumor Assessment Week 018: Severe Problems | 4 |
| Tumor Assessment Week 018: Invalid Response | 1 |
| Tumor Assessment Week 024: No Problem | 140 |
| Tumor Assessment Week 024: Slight Problems | 62 |
| Tumor Assessment Week 024: Moderate Problems | 13 |
| Tumor Assessment Week 024: Severe Problems | 5 |
| Tumor Assessment Week 030: No Problem | 116 |
| Tumor Assessment Week 030: Slight Problems | 56 |
| Tumor Assessment Week 030: Moderate Problems | 11 |
| Tumor Assessment Week 030: Severe Problems | 1 |
| Tumor Assessment Week 036: No Problem | 105 |
| Tumor Assessment Week 036: Slight Problems | 46 |
| Tumor Assessment Week 036: Moderate Problems | 9 |
| Tumor Assessment Week 036: Severe Problems | 2 |
| Tumor Assessment Week 042: No Problem | 90 |
| Tumor Assessment Week 042: Slight Problems | 42 |
| Tumor Assessment Week 042: Moderate Problems | 10 |
| Tumor Assessment Week 042: Severe Problems | 3 |
| Tumor Assessment Week 048: No Problem | 81 |
| Tumor Assessment Week 048: Slight Problems | 34 |
| Tumor Assessment Week 048: Moderate Problems | 11 |
| Tumor Assessment Week 054: No Problem | 13 |
| Tumor Assessment Week 054: Slight Problems | 7 |
| Tumor Assessment Week 054: Moderate Problems | 3 |
| Tumor Assessment Week 057: No Problem | 68 |
| Tumor Assessment Week 057: Slight Problems | 18 |
| Tumor Assessment Week 057: Moderate Problems | 9 |
| Tumor Assessment Week 057: Severe Problems | 2 |
| Tumor Assessment Week 060: No Problem | 13 |
| Tumor Assessment Week 060: Slight Problems | 2 |
| Tumor Assessment Week 060: Moderate Problems | 2 |
| Tumor Assessment Week 066: No Problem | 63 |
| Tumor Assessment Week 066: Slight Problems | 15 |
| Tumor Assessment Week 066: Moderate Problems | 7 |
| Tumor Assessment Week 066: Severe Problems | 2 |
| Tumor Assessment Week 066: Extreme Problems | 1 |
| Tumor Assessment Week 072: No Problem | 8 |
| Tumor Assessment Week 072: Slight Problems | 3 |
| Tumor Assessment Week 072: Moderate Problems | 2 |
| Tumor Assessment Week 075: No Problem | 51 |
| Tumor Assessment Week 075: Slight Problems | 19 |
| Tumor Assessment Week 075: Moderate Problems | 1 |
| Tumor Assessment Week 075: Severe Problems | 2 |
| Tumor Assessment Week 078: No Problem | 7 |
| Tumor Assessment Week 078: Slight Problems | 2 |
| Tumor Assessment Week 078: Moderate Problems | 1 |
| Tumor Assessment Week 084: No Problem | 45 |
| Tumor Assessment Week 084: Slight Problems | 14 |
| Tumor Assessment Week 084: Moderate Problems | 6 |
| Tumor Assessment Week 084: Severe Problems | 1 |
| Tumor Assessment Week 084: Extreme Problems | 1 |
| Tumor Assessment Week 090: No Problem | 6 |
| Tumor Assessment Week 090: Slight Problems | 2 |
| Tumor Assessment Week 090: Moderate Problems | 1 |
| Tumor Assessment Week 090: Severe Problems | 1 |
| Tumor Assessment Week 093: No Problem | 36 |
| Tumor Assessment Week 093: Slight Problems | 12 |
| Tumor Assessment Week 093: Moderate Problems | 4 |
| Tumor Assessment Week 093: Severe Problems | 1 |
| Tumor Assessment Week 096: No Problem | 3 |
| Tumor Assessment Week 096: Slight Problems | 2 |
| Tumor Assessment Week 096: Moderate Problems | 1 |
| Tumor Assessment Week 096: Severe Problems | 1 |
| Tumor Assessment Week 102: No Problem | 36 |
| Tumor Assessment Week 102: Slight Problems | 15 |
| Tumor Assessment Week 102: Moderate Problems | 2 |
| Tumor Assessment Week 102: Severe Problems | 2 |
| Tumor Assessment Week 108: No Problem | 2 |
| Tumor Assessment Week 108: Slight Problems | 4 |
| Tumor Assessment Week 108: Severe Problems | 1 |
| Tumor Assessment Week 111: No Problem | 27 |
| Tumor Assessment Week 111: Slight Problems | 9 |
| Tumor Assessment Week 111: Moderate Problems | 3 |
| Tumor Assessment Week 111: Severe Problems | 1 |
| Tumor Assessment Week 114: Slight Problems | 1 |
| Tumor Assessment Week 114: Moderate Problems | 1 |
| Tumor Assessment Week 120: No Problem | 24 |
| Tumor Assessment Week 120: Slight Problems | 11 |
| Tumor Assessment Week 120: Moderate Problems | 3 |
| Tumor Assessment Week 126: No Problem | 2 |
| Tumor Assessment Week 126: Slight Problems | 1 |
| Tumor Assessment Week 126: Moderate Problems | 1 |
| Tumor Assessment Week 129: No Problem | 21 |
| Tumor Assessment Week 129: Slight Problems | 10 |
| Tumor Assessment Week 129: Severe Problems | 1 |
| Tumor Assessment Week 132: No Problem | 1 |
| Tumor Assessment Week 132: Moderate problems | 1 |
| Tumor Assessment Week 138: No Problem | 19 |
| Tumor Assessment Week 138: Slight Problems | 6 |
| Tumor Assessment Week 138: Moderate Problems | 2 |
| Tumor Assessment Week 138: Invalid Response | 1 |
| Tumor Assessment Week 144: No Problem | 1 |
| Tumor Assessment Week 147: No Problem | 14 |
| Tumor Assessment Week 147: Slight Problems | 6 |
| Tumor Assessment Week 147: Severe Problems | 1 |
| Tumor Assessment Week 156: No Problem | 12 |
| Tumor Assessment Week 156: Slight Problems | 2 |
| Tumor Assessment Week 156: Moderate Problems | 1 |
| Tumor Assessment Week 165: No Problem | 8 |
| Tumor Assessment Week 165: Slight Problems | 3 |
| Tumor Assessment Week 165: Moderate Problems | 1 |
| Tumor Assessment Week 165: Invalid Response | 1 |
| Tumor Assessment Week 174: No Problem | 8 |
| Tumor Assessment Week 174: Slight Problems | 2 |
| Tumor Assessment Week 183: No Problem | 2 |
| Tumor Assessment Week 183: Slight Problems | 1 |
The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Values presented after baseline represent the change from baseline.
| score on a scale | Atezolizumab |
|---|---|
| Cycle 2 Day 1 | -0.51 ± 13.61 |
| Tumor Assessment Week 06 | -1.14 ± 15.17 |
| Tumor Assessment Week 012 | 0.97 ± 14.07 |
| Tumor Assessment Week 018 | 2.23 ± 14.24 |
| Tumor Assessment Week 024 | 1.78 ± 15.48 |
| Tumor Assessment Week 030 | 3.04 ± 13.97 |
| Tumor Assessment Week 036 | 2.11 ± 15.56 |
| Tumor Assessment Week 042 | 3.14 ± 14.84 |
| Tumor Assessment Week 048 | 2.55 ± 14.76 |
| Tumor Assessment Week 054 | 0.45 ± 16.25 |
| Tumor Assessment Week 057 | 4.99 ± 12.94 |
| Tumor Assessment Week 060 | 6.53 ± 9.68 |
| Tumor Assessment Week 066 | 2.64 ± 12.42 |
| Tumor Assessment Week 072 | 2.46 ± 10.82 |
| Tumor Assessment Week 075 | 3.13 ± 14.36 |
| Tumor Assessment Week 078 | 6.00 ± 9.94 |
| Tumor Assessment Week 084 | 4.26 ± 16.91 |
| Tumor Assessment Week 090 | 2.80 ± 10.55 |
| Tumor Assessment Week 093 | 5.47 ± 15.35 |
| Tumor Assessment Week 096 | 6.43 ± 18.42 |
| Tumor Assessment Week 102 | 4.98 ± 14.28 |
| Tumor Assessment Week 108 | 10.71 ± 14.56 |
| Tumor Assessment Week 111 | 4.64 ± 13.16 |
| Tumor Assessment Week 114 | 15.00 ± 0.00 |
| Tumor Assessment Week 120 | 5.65 ± 14.18 |
| Tumor Assessment Week 126 | 16.25 ± 4.79 |
| Tumor Assessment Week 129 | 4.26 ± 13.99 |
| Tumor Assessment Week 132 | 12.50 ± 17.68 |
| Tumor Assessment Week 138 | 2.85 ± 15.49 |
| Tumor Assessment Week 144 | -8.00 ± NA |
| Tumor Assessment Week 147 | 6.00 ± 13.14 |
| Tumor Assessment Week 156 | 5.67 ± 16.24 |
| Tumor Assessment Week 165 | 7.08 ± 18.52 |
| Tumor Assessment Week 174 | 4.44 ± 13.33 |
| Tumor Assessment Week 183 | 5.33 ± 21.57 |
The EORTC QLQ-LC13 consisted of 13 items that address key lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related adverse effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. The dysphagia scale is multi-item, while the rest are single-item scales. The scales are linearly transformed so that each score has a range from 0 to 100. A high scale score represents a higher response level (e.g. a high score for global health status represents a high QoL). A high score for the symptom scale represents a high level of symptoms. A \>=10-point change in the EORTC scale score was perceived by participants as clinically significant. Values presented after baseline represent the change from baseline.
| Units on a scale | Atezolizumab |
|---|---|
| Dyspnoea: Baseline | 24.82 ± 21.64 |
| Dyspnoea: Cycle (C) 02 Day (D) 01 | 2.41 ± 15.59 |
| Dyspnoea: Tumor Assessment Wk 006 | 1.59 ± 18.91 |
| Dyspnoea: Tumor Assessment Wk 012 | -0.62 ± 19.40 |
| Dyspnoea: Tumor Assessment Wk 018 | -0.50 ± 17.91 |
| Dyspnoea: Tumor Assessment Wk 024 | -2.84 ± 17.90 |
| Dyspnoea: Tumor Assessment Wk 030 | -1.17 ± 21.29 |
| Dyspnoea: Tumor Assessment Wk 036 | -3.91 ± 20.51 |
| Dyspnoea: Tumor Assessment Wk 042 | -3.97 ± 19.10 |
| Dyspnoea: Tumor Assessment Wk 048 | -3.65 ± 20.44 |
| Dyspnoea: Tumor Assessment Wk 054 | 2.38 ± 16.98 |
| Dyspnoea: Tumor Assessment Wk 057 | -5.25 ± 18.13 |
| Dyspnoea: Tumor Assessment Wk 060 | -1.11 ± 11.05 |
| Dyspnoea: Tumor Assessment Wk 066 | 1.09 ± 19.53 |
| Dyspnoea: Tumor Assessment Wk 072 | 4.76 ± 30.67 |
| Dyspnoea: Tumor Assessment Wk 075 | -2.22 ± 18.52 |
| Dyspnoea: Tumor Assessment Wk 078 | 0.00 ± 42.31 |
| Dyspnoea: Tumor Assessment Wk 084 | -2.92 ± 16.07 |
| Dyspnoea: Tumor Assessment Wk 090 | -17.78 ± 12.67 |
| Dyspnoea: Tumor Assessment Wk 093 | -3.57 ± 19.38 |
| Dyspnoea: Tumor Assessment Wk 096 | 13.33 ± 27.67 |
| Dyspnoea: Tumor Assessment Wk 102 | -5.95 ± 19.24 |
| Dyspnoea: Tumor Assessment Wk 108 | -8.89 ± 26.53 |
| Dyspnoea: Tumor Assessment Wk 111 | -6.88 ± 17.02 |
| Dyspnoea: Tumor Assessment Wk 114 | -16.67 ± 23.57 |
| Dyspnoea: Tumor Assessment Wk 120 | -5.85 ± 14.04 |
| Dyspnoea: Tumor Assessment Wk 126 | -18.52 ± 27.96 |
| Dyspnoea: Tumor Assessment Wk 129 | -7.19 ± 13.57 |
| Dyspnoea: Tumor Assessment Wk 132 | -22.22 |
| Dyspnoea: Tumor Assessment Wk 138 | -1.71 ± 11.87 |
| Dyspnoea: Tumor Assessment Wk 144 | 0.00 |
| Dyspnoea: Tumor Assessment Wk 147 | -3.70 ± 7.86 |
| Dyspnoea: Tumor Assessment Wk 156 | 6.94 ± 23.71 |
| Dyspnoea: Tumor Assessment Wk 165 | 3.70 ± 23.13 |
| Dyspnoea: Tumor Assessment Wk 174 | 0.00 |
| Dyspnoea: Tumor Assessment Wk 183 | -11.11 |
| Coughing: Baseline | 33.84 ± 25.94 |
| Coughing: C2D1 | 0.80 ± 21.89 |
| Coughing: Tumor Assessment Wk 006 | -0.68 ± 24.84 |
| Coughing: Tumor Assessment Wk 012 | -4.44 ± 28.35 |
| Coughing: Tumor Assessment Wk 018 | -7.88 ± 25.61 |
| Coughing: Tumor Assessment Wk 024 | -7.83 ± 26.95 |
| Coughing: Tumor Assessment Wk 030 | -7.18 ± 26.30 |
| Coughing: Tumor Assessment Wk 036 | -9.32 ± 25.71 |
| Coughing: Tumor Assessment Wk 042 | -13.18 ± 25.71 |
| Coughing: Tumor Assessment Wk 048 | -9.26 ± 30.76 |
| Coughing: Tumor Assessment Wk 054 | -2.38 ± 24.33 |
| Coughing: Tumor Assessment Wk 057 | -13.22 ± 28.57 |
| Coughing: Tumor Assessment Wk 060 | -9.09 ± 21.56 |
| Coughing: Tumor Assessment Wk 066 | -10.69 ± 28.32 |
| Coughing: Tumor Assessment Wk 072 | -4.76 ± 23.00 |
| Coughing: Tumor Assessment Wk 075 | -18.33 ± 28.19 |
| Coughing: Tumor Assessment Wk 078 | 0.00 ± 33.33 |
| Coughing: Tumor Assessment Wk 084 | -16.67 ± 31.72 |
| Coughing: Tumor Assessment Wk 090 | -16.67 ± 18.26 |
| Coughing: Tumor Assessment Wk 093 | -16.67 ± 30.77 |
| Coughing: Tumor Assessment Wk 096 | 6.67 ± 14.91 |
| Coughing: Tumor Assessment Wk 102 | -23.81 ± 25.43 |
| Coughing: Tumor Assessment Wk 108 | -6.67 ± 27.89 |
| Coughing: Tumor Assessment Wk 111 | -11.11 ± 30.43 |
| Coughing: Tumor Assessment Wk 114 | -16.67 ± 23.57 |
| Coughing: Tumor Assessment Wk 120 | -12.28 ± 29.84 |
| Coughing: Tumor Assessment Wk 126 | 0.00 ± 33.33 |
| Coughing: Tumor Assessment Wk 129 | -11.76 ± 26.20 |
| Coughing: Tumor Assessment Wk 132 | 0.00 |
| Coughing: Tumor Assessment Wk 138 | -14.29 ± 31.25 |
| Coughing: Tumor Assessment Wk 144 | 33.33 |
| Coughing: Tumor Assessment Wk 147 | -22.22 ± 40.82 |
| Coughing: Tumor Assessment Wk 156 | -12.50 ± 53.27 |
| Coughing: Tumor Assessment Wk 165 | 0.00 ± 33.33 |
| Coughing: Tumor Assessment Wk 174 | 33.33 |
| Coughing: Tumor Assessment Wk 183 | 0.00 |
| Haemoptysis: Baseline | 3.02 ± 10.15 |
| Haemoptysis: C2D1 | 0.60 ± 9.05 |
| Haemoptysis: Tumor Assessment Wk 006 | 0.10 ± 9.81 |
| Haemoptysis: Tumor Assessment Wk 012 | 0.15 ± 9.77 |
| Haemoptysis: Tumor Assessment Wk 018 | -0.18 ± 8.96 |
| Haemoptysis: Tumor Assessment Wk 024 | -0.67 ± 9.06 |
| Haemoptysis: Tumor Assessment Wk 030 | -0.29 ± 10.31 |
| Haemoptysis: Tumor Assessment Wk 036 | -1.79 ± 10.27 |
| Haemoptysis: Tumor Assessment Wk 042 | 0.00 ± 11.43 |
| Haemoptysis: Tumor Assessment Wk 048 | -0.46 ± 8.83 |
| Haemoptysis: Tumor Assessment Wk 054 | 0.00 ± 13.07 |
| Haemoptysis: Tumor Assessment Wk 057 | 0.00 ± 10.91 |
| Haemoptysis: Tumor Assessment Wk 060 | 0.00 ± 14.91 |
| Haemoptysis: Tumor Assessment Wk 066 | -2.52 ± 8.89 |
| Haemoptysis: Tumor Assessment Wk 072 | 0.00 ± 0.00 |
| Haemoptysis: Tumor Assessment Wk 075 | -3.33 ± 10.13 |
| Haemoptysis: Tumor Assessment Wk 078 | 0.00 ± 0.00 |
| Haemoptysis: Tumor Assessment Wk 084 | -2.63 ± 9.11 |
| Haemoptysis: Tumor Assessment Wk 090 | 5.56 ± 13.61 |
| Haemoptysis: Tumor Assessment Wk 093 | 1.19 ± 14.29 |
| Haemoptysis: Tumor Assessment Wk 096 | 0.00 ± 0.00 |
| Haemoptysis: Tumor Assessment Wk 102 | -2.38 ± 8.74 |
| Haemoptysis: Tumor Assessment Wk 108 | 0.00 ± 0.00 |
| Haemoptysis: Tumor Assessment Wk 111 | -3.17 ± 10.03 |
| Haemoptysis: Tumor Assessment Wk 114 | 0.00 ± 0.00 |
| Haemoptysis: Tumor Assessment Wk 120 | -1.75 ± 13.49 |
| Haemoptysis: Tumor Assessment Wk 126 | 0.00 ± 0.00 |
| Haemoptysis: Tumor Assessment Wk 129 | -1.96 ± 14.29 |
| Haemoptysis: Tumor Assessment Wk 132 | 0.00 |
| Haemoptysis: Tumor Assessment Wk 138 | -2.38 ± 15.82 |
| Haemoptysis: Tumor Assessment Wk 144 | 0.00 |
| Haemoptysis: Tumor Assessment Wk 147 | 0.00 ± 16.67 |
| Haemoptysis: Tumor Assessment Wk 156 | 0.00 ± 0.00 |
| Haemoptysis: Tumor Assessment Wk 165 | 0.00 ± 33.33 |
| Haemoptysis: Tumor Assessment Wk 174 | -33.33 |
| Haemoptysis: Tumor Assessment Wk 183 | 0.00 |
| Sore mouth: Baseline | 3.58 ± 12.33 |
| Sore mouth: C2D1 | 0.67 ± 15.76 |
| Sore mouth: Tumor Assessment Wk 006 | 0.49 ± 16.95 |
| Sore mouth: Tumor Assessment Wk 012 | 0.00 ± 16.55 |
| Sore mouth: Tumor Assessment Wk 018 | -0.73 ± 14.00 |
| Sore mouth: Tumor Assessment Wk 024 | -1.13 ± 14.24 |
| Sore mouth: Tumor Assessment Wk 030 | -2.03 ± 14.16 |
| Sore mouth: Tumor Assessment Wk 036 | -2.54 ± 15.02 |
| Sore mouth: Tumor Assessment Wk 042 | -1.57 ± 16.99 |
| Sore mouth: Tumor Assessment Wk 048 | -4.29 ± 15.97 |
| Sore mouth: Tumor Assessment Wk 054 | 2.56 ± 16.45 |
| Sore mouth: Tumor Assessment Wk 057 | -1.75 ± 11.65 |
| Sore mouth: Tumor Assessment Wk 060 | -3.33 ± 10.54 |
| Sore mouth: Tumor Assessment Wk 066 | -2.56 ± 14.53 |
| Sore mouth: Tumor Assessment Wk 072 | 0.00 ± 0.00 |
| Sore mouth: Tumor Assessment Wk 075 | -2.50 ± 13.89 |
| Sore mouth: Tumor Assessment Wk 078 | 6.67 ± 14.91 |
| Sore mouth: Tumor Assessment Wk 084 | -1.75 ± 13.30 |
| Sore mouth: Tumor Assessment Wk 090 | 0.00 ± 0.00 |
| Sore mouth: Tumor Assessment Wk 093 | 2.38 ± 8.74 |
| Sore mouth: Tumor Assessment Wk 096 | 0.00 ± 0.00 |
| Sore mouth: Tumor Assessment Wk 102 | 1.19 ± 6.30 |
| Sore mouth: Tumor Assessment Wk 108 | 0.00 ± 0.00 |
| Sore mouth: Tumor Assessment Wk 111 | 3.17 ± 10.03 |
| Sore mouth: Tumor Assessment Wk 114 | 33.33 ± 47.14 |
| Sore mouth: Tumor Assessment Wk 120 | 7.02 ± 17.84 |
| Sore mouth: Tumor Assessment Wk 126 | 11.11 ± 19.25 |
| Sore mouth: Tumor Assessment Wk 129 | 0.00 ± 0.00 |
| Sore mouth: Tumor Assessment Wk 132 | 33.33 |
| Sore mouth: Tumor Assessment Wk 138 | 2.38 ± 8.91 |
| Sore mouth: Tumor Assessment Wk 144 | 0.00 |
| Sore mouth: Tumor Assessment Wk 147 | 0.00 ± 0.00 |
| Sore mouth: Tumor Assessment Wk 156 | 0.00 ± 0.00 |
| Sore mouth: Tumor Assessment Wk 165 | 0.00 ± 0.00 |
| Sore mouth: Tumor Assessment Wk 174 | 0.00 |
| Sore mouth: Tumor Assessment Wk 183 | 0.00 |
| Dysphagia: Baseline | 5.46 ± 14.73 |
| Dysphagia: C2D1 | 0.20 ± 13.92 |
| Dysphagia: Tumor Assessment Wk 006 | -1.38 ± 13.74 |
| Dysphagia: Tumor Assessment Wk 012 | -0.15 ± 16.63 |
| Dysphagia: Tumor Assessment Wk 018 | 0.74 ± 16.08 |
| Dysphagia: Tumor Assessment Wk 024 | -1.59 ± 11.26 |
| Dysphagia: Tumor Assessment Wk 030 | -1.46 ± 10.30 |
| Dysphagia: Tumor Assessment Wk 036 | -1.83 ± 16.00 |
| Dysphagia: Tumor Assessment Wk 042 | -1.59 ± 13.60 |
| Dysphagia: Tumor Assessment Wk 048 | -0.48 ± 15.53 |
| Dysphagia: Tumor Assessment Wk 054 | -2.56 ± 9.25 |
| Dysphagia: Tumor Assessment Wk 057 | -0.58 ± 9.94 |
| Dysphagia: Tumor Assessment Wk 060 | 0.00 ± 0.00 |
| Dysphagia: Tumor Assessment Wk 066 | -1.28 ± 11.36 |
| Dysphagia: Tumor Assessment Wk 072 | 0.00 ± 0.00 |
| Dysphagia: Tumor Assessment Wk 075 | 0.00 ± 15.10 |
| Dysphagia: Tumor Assessment Wk 078 | 0.00 ± 0.00 |
| Dysphagia: Tumor Assessment Wk 084 | -2.63 ± 11.96 |
| Dysphagia: Tumor Assessment Wk 090 | 0.00 ± 0.00 |
| Dysphagia: Tumor Assessment Wk 093 | -2.38 ± 8.74 |
| Dysphagia: Tumor Assessment Wk 096 | 6.67 ± 14.91 |
| Dysphagia: Tumor Assessment Wk 102 | -2.38 ± 8.74 |
| Dysphagia: Tumor Assessment Wk 108 | 0.00 ± 0.00 |
| Dysphagia: Tumor Assessment Wk 111 | 0.00 ± 10.54 |
| Dysphagia: Tumor Assessment Wk 114 | 0.00 ± 0.00 |
| Dysphagia: Tumor Assessment Wk 120 | -1.75 ± 7.65 |
| Dysphagia: Tumor Assessment Wk 126 | 0.00 ± 0.00 |
| Dysphagia: Tumor Assessment Wk 129 | 0.00 ± 0.00 |
| Dysphagia: Tumor Assessment Wk 132 | 0.00 |
| Dysphagia: Tumor Assessment Wk 138 | 0.00 ± 0.00 |
| Dysphagia: Tumor Assessment Wk 144 | 0.00 |
| Dysphagia: Tumor Assessment Wk 147 | 0.00 ± 0.00 |
| Dysphagia: Tumor Assessment Wk 156 | 4.17 ± 11.79 |
| Dysphagia: Tumor Assessment Wk 165 | 0.00 ± 0.00 |
| Dysphagia: Tumor Assessment Wk 174 | 0.00 |
| Dysphagia: Tumor Assessment Wk 183 | 0.00 |
| Peripheral neuropathy: Baseline | 17.77 ± 26.96 |
| Peripheral neuropathy: C2D1 | -0.20 ± 22.29 |
| Peripheral neuropathy: Tumor Assessment Wk 006 | -0.58 ± 21.80 |
| Peripheral neuropathy: Tumor Assessment Wk 012 | 0.15 ± 24.20 |
| Peripheral neuropathy: Tumor Assessment Wk 018 | -2.56 ± 26.56 |
| Peripheral neuropathy: Tumor Assessment Wk 024 | -3.15 ± 25.30 |
| Peripheral neuropathy: Tumor Assessment Wk 030 | -3.19 ± 24.17 |
| Peripheral neuropathy: Tumor Assessment Wk 036 | -6.23 ± 25.29 |
| Peripheral neuropathy: Tumor Assessment Wk 042 | -7.45 ± 28.35 |
| Peripheral neuropathy: Tumor Assessment Wk 048 | -8.92 ± 27.58 |
| Peripheral neuropathy: Tumor Assessment Wk 054 | -7.69 ± 19.97 |
| Peripheral neuropathy: Tumor Assessment Wk 057 | -6.32 ± 20.19 |
| Peripheral neuropathy: Tumor Assessment Wk 060 | -13.33 ± 17.21 |
| Peripheral neuropathy: Tumor Assessment Wk 066 | -3.85 ± 22.53 |
| Peripheral neuropathy: Tumor Assessment Wk 072 | -4.76 ± 23.00 |
| Peripheral neuropathy: Tumor Assessment Wk 075 | -10.83 ± 26.57 |
| Peripheral neuropathy: Tumor Assessment Wk 078 | -6.67 ± 27.89 |
| Peripheral neuropathy: Tumor Assessment Wk 084 | -9.65 ± 28.90 |
| Peripheral neuropathy: Tumor Assessment Wk 090 | 0.00 ± 21.08 |
| Peripheral neuropathy: Tumor Assessment Wk 093 | -5.95 ± 30.16 |
| Peripheral neuropathy: Tumor Assessment Wk 096 | 6.67 ± 14.91 |
| Peripheral neuropathy: Tumor Assessment Wk 102 | -8.33 ± 26.64 |
| Peripheral neuropathy: Tumor Assessment Wk 108 | -6.67 ± 14.91 |
| Peripheral neuropathy: Tumor Assessment Wk 111 | -14.29 ± 34.27 |
| Peripheral neuropathy: Tumor Assessment Wk 114 | -16.67 ± 23.57 |
| Peripheral neuropathy: Tumor Assessment Wk 120 | -14.04 ± 32.04 |
| Peripheral neuropathy: Tumor Assessment Wk 126 | -11.11 ± 19.25 |
| Peripheral neuropathy: Tumor Assessment Wk 129 | -7.84 ± 25.08 |
| Peripheral neuropathy: Tumor Assessment Wk 132 | 0.00 |
| Peripheral neuropathy: Tumor Assessment Wk 138 | -19.05 ± 33.88 |
| Peripheral neuropathy: Tumor Assessment Wk 144 | 0.00 |
| Peripheral neuropathy: Tumor Assessment Wk 147 | -22.22 ± 40.82 |
| Peripheral neuropathy: Tumor Assessment Wk 156 | -12.50 ± 50.20 |
| Peripheral neuropathy: Tumor Assessment Wk 165 | 11.11 ± 19.25 |
| Peripheral neuropathy: Tumor Assessment Wk 174 | 33.33 |
| Peripheral neuropathy: Tumor Assessment Wk 183 | 33.33 |
| Alopecia: Baseline | 13.95 ± 27.14 |
| Alopecia: C2D1 | -5.64 ± 24.32 |
| Alopecia: Tumor Assessment Wk 006 | -4.31 ± 24.84 |
| Alopecia: Tumor Assessment Wk 012 | -5.98 ± 25.39 |
| Alopecia: Tumor Assessment Wk 018 | -6.85 ± 24.59 |
| Alopecia: Tumor Assessment Wk 024 | -8.11 ± 24.16 |
| Alopecia: Tumor Assessment Wk 030 | -6.96 ± 25.93 |
| Alopecia: Tumor Assessment Wk 036 | -6.52 ± 25.79 |
| Alopecia: Tumor Assessment Wk 042 | -6.67 ± 26.13 |
| Alopecia: Tumor Assessment Wk 048 | -7.51 ± 26.55 |
| Alopecia: Tumor Assessment Wk 054 | 2.56 ± 9.25 |
| Alopecia: Tumor Assessment Wk 057 | -6.43 ± 27.77 |
| Alopecia: Tumor Assessment Wk 060 | 0.00 ± 15.71 |
| Alopecia: Tumor Assessment Wk 066 | -6.41 ± 26.44 |
| Alopecia: Tumor Assessment Wk 072 | 9.52 ± 16.27 |
| Alopecia: Tumor Assessment Wk 075 | -6.67 ± 27.43 |
| Alopecia: Tumor Assessment Wk 078 | 13.33 ± 18.26 |
| Alopecia: Tumor Assessment Wk 084 | -6.14 ± 26.68 |
| Alopecia: Tumor Assessment Wk 090 | 5.56 ± 13.61 |
| Alopecia: Tumor Assessment Wk 093 | -4.76 ± 28.28 |
| Alopecia: Tumor Assessment Wk 096 | 6.67 ± 14.91 |
| Alopecia: Tumor Assessment Wk 102 | -4.76 ± 26.78 |
| Alopecia: Tumor Assessment Wk 108 | 20.00 ± 18.26 |
| Alopecia: Tumor Assessment Wk 111 | -3.17 ± 27.70 |
| Alopecia: Tumor Assessment Wk 114 | 16.67 ± 23.57 |
| Alopecia: Tumor Assessment Wk 120 | 3.51 ± 29.18 |
| Alopecia: Tumor Assessment Wk 126 | 22.22 ± 19.25 |
| Alopecia: Tumor Assessment Wk 129 | 5.88 ± 17.62 |
| Alopecia: Tumor Assessment Wk 132 | 0.00 |
| Alopecia: Tumor Assessment Wk 138 | -4.76 ± 28.81 |
| Alopecia: Tumor Assessment Wk 144 | 0.00 |
| Alopecia: Tumor Assessment Wk 147 | -7.41 ± 36.43 |
| Alopecia: Tumor Assessment Wk 156 | -4.17 ± 45.21 |
| Alopecia: Tumor Assessment Wk 165 | 0.00 ± 0.00 |
| Alopecia: Tumor Assessment Wk 174 | 0.00 |
| Alopecia: Tumor Assessment Wk 183 | 33.33 |
| Pain in chest: Baseline | 14.20 ± 21.62 |
| Pain in chest: C2D1 | 0.13 ± 19.74 |
| Pain in chest: Tumor Assessment Wk 006 | 0.10 ± 23.99 |
| Pain in chest: Tumor Assessment Wk 012 | -0.75 ± 22.35 |
| Pain in chest: Tumor Assessment Wk 018 | -1.12 ± 18.38 |
| Pain in chest: Tumor Assessment Wk 024 | -2.74 ± 18.16 |
| Pain in chest: Tumor Assessment Wk 030 | -1.77 ± 20.82 |
| Pain in chest: Tumor Assessment Wk 036 | -2.96 ± 20.39 |
| Pain in chest: Tumor Assessment Wk 042 | -2.41 ± 20.02 |
| Pain in chest: Tumor Assessment Wk 048 | -4.35 ± 22.80 |
| Pain in chest: Tumor Assessment Wk 054 | 0.00 ± 20.10 |
| Pain in chest: Tumor Assessment Wk 057 | -6.06 ± 21.36 |
| Pain in chest: Tumor Assessment Wk 060 | 7.41 ± 22.22 |
| Pain in chest: Tumor Assessment Wk 066 | -3.33 ± 20.48 |
| Pain in chest: Tumor Assessment Wk 072 | -14.29 ± 17.82 |
| Pain in chest: Tumor Assessment Wk 075 | -6.14 ± 18.75 |
| Pain in chest: Tumor Assessment Wk 078 | -16.67 ± 19.25 |
| Pain in chest: Tumor Assessment Wk 084 | -7.41 ± 16.16 |
| Pain in chest: Tumor Assessment Wk 090 | -6.67 ± 14.91 |
| Pain in chest: Tumor Assessment Wk 093 | -1.33 ± 15.15 |
| Pain in chest: Tumor Assessment Wk 096 | -8.33 ± 16.67 |
| Pain in chest: Tumor Assessment Wk 102 | -8.97 ± 15.08 |
| Pain in chest: Tumor Assessment Wk 108 | -13.33 ± 18.26 |
| Pain in chest: Tumor Assessment Wk 111 | -5.00 ± 16.31 |
| Pain in chest: Tumor Assessment Wk 114 | -33.33 ± 0.00 |
| Pain in chest: Tumor Assessment Wk 120 | -7.41 ± 18.28 |
| Pain in chest: Tumor Assessment Wk 126 | -11.11 ± 19.25 |
| Pain in chest: Tumor Assessment Wk 129 | -6.25 ± 18.13 |
| Pain in chest: Tumor Assessment Wk 132 | -33.33 |
| Pain in chest: Tumor Assessment Wk 138 | -5.13 ± 22.96 |
| Pain in chest: Tumor Assessment Wk 144 | -33.33 |
| Pain in chest: Tumor Assessment Wk 147 | -4.17 ± 21.36 |
| Pain in chest: Tumor Assessment Wk 156 | -9.52 ± 16.27 |
| Pain in chest: Tumor Assessment Wk 165 | 11.11 ± 19.25 |
| Pain in chest: Tumor Assessment Wk 174 | 0.00 |
| Pain in chest: Tumor Assessment Wk 183 | 33.33 |
| Pain in arm or shoulder: Baseline | 16.09 ± 24.63 |
| Pain in arm or shoulder: C2D1 | 1.81 ± 21.67 |
| Pain in arm or shoulder: Tumor Assessment Wk 006 | -0.30 ± 23.85 |
| Pain in arm or shoulder: Tumor Assessment Wk 012 | 0.75 ± 24.09 |
| Pain in arm or shoulder: Tumor Assessment Wk 018 | 3.15 ± 28.78 |
| Pain in arm or shoulder: Tumor Assessment Wk 024 | -0.68 ± 23.56 |
| Pain in arm or shoulder: Tumor Assessment Wk 030 | 0.00 ± 25.86 |
| Pain in arm or shoulder: Tumor Assessment Wk 036 | -2.20 ± 22.11 |
| Pain in arm or shoulder: Tumor Assessment Wk 042 | -1.19 ± 24.51 |
| Pain in arm or shoulder: Tumor Assessment Wk 048 | -2.38 ± 24.95 |
| Pain in arm or shoulder: Tumor Assessment Wk 054 | 2.56 ± 21.35 |
| Pain in arm or shoulder: Tumor Assessment Wk 057 | 1.72 ± 26.80 |
| Pain in arm or shoulder: Tumor Assessment Wk 060 | -6.67 ± 21.08 |
| Pain in arm or shoulder: Tumor Assessment Wk 066 | 0.64 ± 21.38 |
| Pain in arm or shoulder: Tumor Assessment Wk 072 | 4.76 ± 23.00 |
| Pain in arm or shoulder: Tumor Assessment Wk 075 | -4.27 ± 23.17 |
| Pain in arm or shoulder: Tumor Assessment Wk 078 | 16.67 ± 19.25 |
| Pain in arm or shoulder: Tumor Assessment Wk 084 | -9.01 ± 23.11 |
| Pain in arm or shoulder: Tumor Assessment Wk 090 | 0.00 ± 23.57 |
| Pain in arm or shoulder: Tumor Assessment Wk 093 | -9.88 ± 20.29 |
| Pain in arm or shoulder: Tumor Assessment Wk 096 | -8.33 ± 16.67 |
| Pain in arm or shoulder: Tumor Assessment Wk 102 | -4.94 ± 20.05 |
| Pain in arm or shoulder: Tumor Assessment Wk 108 | 0.00 ± 23.57 |
| Pain in arm or shoulder: Tumor Assessment Wk 111 | -6.35 ± 20.05 |
| Pain in arm or shoulder: Tumor Assessment Wk 114 | 16.67 ± 23.57 |
| Pain in arm or shoulder: Tumor Assessment Wk 120 | -7.02 ± 21.02 |
| Pain in arm or shoulder: Tumor Assessment Wk 126 | 22.22 ± 19.25 |
| Pain in arm or shoulder: Tumor Assessment Wk 129 | -7.84 ± 18.74 |
| Pain in arm or shoulder: Tumor Assessment Wk 132 | 0.00 |
| Pain in arm or shoulder: Tumor Assessment Wk 138 | -11.90 ± 16.57 |
| Pain in arm or shoulder: Tumor Assessment Wk 144 | -33.33 |
| Pain in arm or shoulder: Tumor Assessment Wk 147 | -11.11 ± 16.67 |
| Pain in arm or shoulder: Tumor Assessment Wk 156 | -12.50 ± 17.25 |
| Pain in arm or shoulder: Tumor Assessment Wk 165 | -11.11 ± 19.25 |
| Pain in arm or shoulder: Tumor Assessment Wk 174 | -33.33 |
| Pain in arm or shoulder: Tumor Assessment Wk 183 | 0.00 |
| Pain in other parts: Baseline | 25.46 ± 30.26 |
| Pain in other parts: C2D1 | -0.49 ± 27.84 |
| Pain in other parts: Tumor Assessment Wk 006 | 1.12 ± 31.80 |
| Pain in other parts: Tumor Assessment Wk 012 | 0.93 ± 28.33 |
| Pain in other parts: Tumor Assessment Wk 018 | -1.19 ± 23.89 |
| Pain in other parts: Tumor Assessment Wk 024 | -1.41 ± 23.11 |
| Pain in other parts: Tumor Assessment Wk 030 | -0.62 ± 21.95 |
| Pain in other parts: Tumor Assessment Wk 036 | -4.17 ± 19.45 |
| Pain in other parts: Tumor Assessment Wk 042 | -4.17 ± 24.52 |
| Pain in other parts: Tumor Assessment Wk 048 | -0.98 ± 23.72 |
| Pain in other parts: Tumor Assessment Wk 054 | 11.11 ± 16.41 |
| Pain in other parts: Tumor Assessment Wk 057 | -5.23 ± 20.41 |
| Pain in other parts: Tumor Assessment Wk 060 | 3.70 ± 11.11 |
| Pain in other parts: Tumor Assessment Wk 066 | -0.67 ± 27.35 |
| Pain in other parts: Tumor Assessment Wk 072 | 4.76 ± 12.60 |
| Pain in other parts: Tumor Assessment Wk 075 | -2.70 ± 25.31 |
| Pain in other parts: Tumor Assessment Wk 078 | 16.67 ± 19.25 |
| Pain in other parts: Tumor Assessment Wk 084 | -3.92 ± 26.92 |
| Pain in other parts: Tumor Assessment Wk 090 | 6.67 ± 14.91 |
| Pain in other parts: Tumor Assessment Wk 093 | -10.26 ± 22.65 |
| Pain in other parts: Tumor Assessment Wk 096 | 0.00 ± 0.00 |
| Pain in other parts: Tumor Assessment Wk 102 | -8.97 ± 22.23 |
| Pain in other parts: Tumor Assessment Wk 108 | 6.67 ± 14.91 |
| Pain in other parts: Tumor Assessment Wk 111 | -8.33 ± 28.36 |
| Pain in other parts: Tumor Assessment Wk 114 | 16.67 ± 23.57 |
| Pain in other parts: Tumor Assessment Wk 120 | -3.92 ± 20.01 |
| Pain in other parts: Tumor Assessment Wk 126 | 33.33 ± 33.33 |
| Pain in other parts: Tumor Assessment Wk 129 | -6.25 ± 18.13 |
| Pain in other parts: Tumor Assessment Wk 132 | 0.00 |
| Pain in other parts: Tumor Assessment Wk 138 | -10.26 ± 21.01 |
| Pain in other parts: Tumor Assessment Wk 144 | 0.00 |
| Pain in other parts: Tumor Assessment Wk 147 | -12.50 ± 24.80 |
| Pain in other parts: Tumor Assessment Wk 156 | -14.29 ± 17.82 |
| Pain in other parts: Tumor Assessment Wk 165 | 0.00 ± 0.00 |
| Pain in other parts: Tumor Assessment Wk 174 | 0.00 |
| Pain in other parts: Tumor Assessment Wk 183 | 0.00 |
| Dyspnoea at Resting: Baseline | 10.47 ± 19.79 |
| Dyspnoea at Resting: C2D1 | 2.53 ± 19.17 |
| Dyspnoea at Resting: Tumor Assessment Wk 006 | 1.68 ± 20.59 |
| Dyspnoea at Resting: Tumor Assessment Wk 012 | 1.65 ± 19.61 |
| Dyspnoea at Resting: Tumor Assessment Wk 018 | 1.83 ± 17.07 |
| Dyspnoea at Resting: Tumor Assessment Wk 024 | -0.23 ± 15.90 |
| Dyspnoea at Resting: Tumor Assessment Wk 030 | 2.03 ± 21.76 |
| Dyspnoea at Resting: Tumor Assessment Wk 036 | 0.37 ± 20.18 |
| Dyspnoea at Resting: Tumor Assessment Wk 042 | -0.40 ± 19.01 |
| Dyspnoea at Resting: Tumor Assessment Wk 048 | 0.95 ± 17.92 |
| Dyspnoea at Resting: Tumor Assessment Wk 054 | 2.38 ± 8.91 |
| Dyspnoea at Resting: Tumor Assessment Wk 057 | -2.38 ± 19.96 |
| Dyspnoea at Resting: Tumor Assessment Wk 060 | 0.00 ± 0.00 |
| Dyspnoea at Resting: Tumor Assessment Wk 066 | 3.27 ± 17.96 |
| Dyspnoea at Resting: Tumor Assessment Wk 072 | 9.52 ± 31.71 |
| Dyspnoea at Resting: Tumor Assessment Wk 075 | -0.83 ± 17.68 |
| Dyspnoea at Resting: Tumor Assessment Wk 078 | 20.00 ± 50.55 |
| Dyspnoea at Resting: Tumor Assessment Wk 084 | -0.88 ± 16.42 |
| Dyspnoea at Resting: Tumor Assessment Wk 090 | 11.11 ± 45.54 |
| Dyspnoea at Resting: Tumor Assessment Wk 093 | 4.76 ± 23.51 |
| Dyspnoea at Resting: Tumor Assessment Wk 096 | 13.33 ± 29.81 |
| Dyspnoea at Resting: Tumor Assessment Wk 102 | -1.19 ± 16.93 |
| Dyspnoea at Resting: Tumor Assessment Wk 108 | -6.67 ± 27.89 |
| Dyspnoea at Resting: Tumor Assessment Wk 111 | -1.59 ± 16.59 |
| Dyspnoea at Resting: Tumor Assessment Wk 114 | -16.67 ± 23.57 |
| Dyspnoea at Resting: Tumor Assessment Wk 120 | -1.75 ± 13.49 |
| Dyspnoea at Resting: Tumor Assessment Wk 126 | -11.11 ± 19.25 |
| Dyspnoea at Resting: Tumor Assessment Wk 129 | -1.96 ± 14.29 |
| Dyspnoea at Resting: Tumor Assessment Wk 132 | 0.00 |
| Dyspnoea at Resting: Tumor Assessment Wk 138 | 7.69 ± 19.97 |
| Dyspnoea at Resting: Tumor Assessment Wk 144 | 0.00 |
| Dyspnoea at Resting: Tumor Assessment Wk 147 | 7.41 ± 14.70 |
| Dyspnoea at Resting: Tumor Assessment Wk 156 | 20.83 ± 17.25 |
| Dyspnoea at Resting: Tumor Assessment Wk 165 | 11.11 ± 19.25 |
| Dyspnoea at Resting: Tumor Assessment Wk 174 | 0.00 |
| Dyspnoea at Resting: Tumor Assessment Wk 183 | 33.33 |
| Dyspnoea at Walking: Baseline | 27.31 ± 26.59 |
| Dyspnoea at Walking: C2D1 | 2.52 ± 21.43 |
| Dyspnoea at Walking: Tumor Assessment Wk 006 | 1.18 ± 23.65 |
| Dyspnoea at Walking: Tumor Assessment Wk 012 | -1.21 ± 26.37 |
| Dyspnoea at Walking: Tumor Assessment Wk 018 | -1.29 ± 24.94 |
| Dyspnoea at Walking: Tumor Assessment Wk 024 | -3.83 ± 26.23 |
| Dyspnoea at Walking: Tumor Assessment Wk 030 | -2.32 ± 26.39 |
| Dyspnoea at Walking: Tumor Assessment Wk 036 | -3.94 ± 27.74 |
| Dyspnoea at Walking: Tumor Assessment Wk 042 | -3.88 ± 25.78 |
| Dyspnoea at Walking: Tumor Assessment Wk 048 | -6.48 ± 27.77 |
| Dyspnoea at Walking: Tumor Assessment Wk 054 | 2.38 ± 27.62 |
| Dyspnoea at Walking: Tumor Assessment Wk 057 | -7.02 ± 23.35 |
| Dyspnoea at Walking: Tumor Assessment Wk 060 | -3.03 ± 17.98 |
| Dyspnoea at Walking: Tumor Assessment Wk 066 | -1.89 ± 25.67 |
| Dyspnoea at Walking: Tumor Assessment Wk 072 | 4.76 ± 29.99 |
| Dyspnoea at Walking: Tumor Assessment Wk 075 | -4.17 ± 22.88 |
| Dyspnoea at Walking: Tumor Assessment Wk 078 | -6.67 ± 54.77 |
| Dyspnoea at Walking: Tumor Assessment Wk 084 | -6.14 ± 23.06 |
| Dyspnoea at Walking: Tumor Assessment Wk 090 | -5.56 ± 38.97 |
| Dyspnoea at Walking: Tumor Assessment Wk 093 | -5.95 ± 24.09 |
| Dyspnoea at Walking: Tumor Assessment Wk 096 | 13.33 ± 38.01 |
| Dyspnoea at Walking: Tumor Assessment Wk 102 | -8.33 ± 26.64 |
| Dyspnoea at Walking: Tumor Assessment Wk 108 | -20.00 ± 29.81 |
| Dyspnoea at Walking: Tumor Assessment Wk 111 | -9.52 ± 26.13 |
| Dyspnoea at Walking: Tumor Assessment Wk 114 | -16.67 ± 23.57 |
| Dyspnoea at Walking: Tumor Assessment Wk 120 | -7.02 ± 21.02 |
| Dyspnoea at Walking: Tumor Assessment Wk 126 | -33.33 ± 33.33 |
| Dyspnoea at Walking: Tumor Assessment Wk 129 | -9.80 ± 19.60 |
| Dyspnoea at Walking: Tumor Assessment Wk 132 | -33.33 |
| Dyspnoea at Walking: Tumor Assessment Wk 138 | -2.38 ± 24.33 |
| Dyspnoea at Walking: Tumor Assessment Wk 144 | 0.00 |
| Dyspnoea at Walking: Tumor Assessment Wk 147 | -3.70 ± 26.06 |
| Dyspnoea at Walking: Tumor Assessment Wk 156 | 4.17 ± 37.53 |
| Dyspnoea at Walking: Tumor Assessment Wk 165 | 11.11 ± 38.49 |
| Dyspnoea at Walking: Tumor Assessment Wk 174 | 0.00 |
| Dyspnoea at Walking: Tumor Assessment Wk 183 | -33.33 |
| Dyspnoea at Climbing Stairs: Baseline | 37.12 ± 29.57 |
| Dyspnoea at Climbing Stairs: C2D1 | 2.23 ± 22.71 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 006 | 1.39 ± 26.23 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 012 | -1.66 ± 27.20 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 018 | -2.04 ± 26.17 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 024 | -4.73 ± 24.90 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 030 | -2.61 ± 28.66 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 036 | -6.81 ± 29.72 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 042 | -5.81 ± 26.17 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 048 | -3.70 ± 29.37 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 054 | 2.38 ± 24.33 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 057 | -6.90 ± 27.75 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 060 | -3.03 ± 17.98 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 066 | 1.89 ± 26.49 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 072 | 0.00 ± 33.33 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 075 | -1.67 ± 28.19 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 078 | -13.33 ± 29.81 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 084 | -1.75 ± 24.44 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 090 | -26.67 ± 14.91 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 093 | -9.52 ± 23.76 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 096 | 13.33 ± 29.81 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 102 | -8.33 ± 26.64 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 108 | 0.00 ± 33.33 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 111 | -9.52 ± 23.90 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 114 | -16.67 ± 23.57 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 120 | -8.77 ± 18.73 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 126 | -11.11 ± 38.49 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 129 | -9.80 ± 22.87 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 132 | -33.33 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 138 | -11.90 ± 24.83 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 144 | 0.00 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 147 | -14.81 ± 17.57 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 156 | -4.17 ± 27.82 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 165 | -11.11 ± 19.25 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 174 | 0.00 |
| Dyspnoea at Climbing Stairs: Tumor Assessment Wk 183 | -33.33 |
PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to modified RECIST.
| Months | Atezolizumab |
|---|---|
| Progression-Free Survival as Evaluated By the Investigator in Accordance With Modified RECIST | 3.7 (3.0 to 4.2) |
The OS rate at 3 years, was defined as the percentage of participants remaining alive 3 years after initiation of study treatment.
| Percentage of Participants | Atezolizumab |
|---|---|
| Percentage of Participants Alive 3 Years After Initiation of Treatment | 19.6 |
Objective response rate (ORR), according to RECIST v1.1, was defined as the percentage of participants with a confirmed best overall response (BOR), either complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1.
| Percentage of Participants | Atezolizumab |
|---|---|
| Percentage of Participants With Objective Reponse as Assessed by the Investigator According to RECIST v1.1 | 11.5 |
The investigator-assessed ORR was defined as the proportion of participants whose confirmed BOR is either a PR or CR per modified RECIST.
| Percentage of Participants | Atezolizumab |
|---|---|
| Percentage of Participants With Objective Reponse as Assessed by the Investigator According to Modified RECIST | 12.4 |
DOR was defined as the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first reported) to documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first, among participants who had a best overall response as CR or PR.
| Months | Atezolizumab |
|---|---|
| Duration of Response as Assessed by the Investigator According to RECIST v.1.1 | 16.6 (9.7 to 20.3) |
DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurred first.
| Months | Atezolizumab |
|---|---|
| Duration of Response as Assessed by the Investigator According to Modified RECIST | 20.5 (16.6 to 28.8) |
Collected over Baseline up to 4 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atezolizumab | 474/619 (76.6%) | 198/615 (32.2%) | 480/615 (78%) |
| Event | Atezolizumab |
|---|---|
| PneumoniaInfections and infestations | 35/615 |
| Lower respiratory tract infectionInfections and infestations | 11/615 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 10/615 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 9/615 |
| PyrexiaGeneral disorders | 7/615 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 6/615 |
| Infusion related reactionInjury, poisoning and procedural complications | 5/615 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 5/615 |
| Acute coronary syndromeCardiac disorders | 4/615 |
| PericarditisCardiac disorders | 4/615 |
| Event | Atezolizumab |
|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 107/615 |
| Decreased appetiteMetabolism and nutrition disorders | 104/615 |
| FatigueGeneral disorders | 100/615 |
| AstheniaGeneral disorders | 93/615 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 85/615 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 83/615 |
| AnaemiaBlood and lymphatic system disorders | 78/615 |
| PyrexiaGeneral disorders | 73/615 |
| DiarrhoeaGastrointestinal disorders | 72/615 |
| NauseaGastrointestinal disorders | 67/615 |
| Age, Continuous(Years) | Atezolizumab |
|---|---|
| Mean | 63.7 ± 9.9 |
| Sex: Female, Male(Participants) | Atezolizumab |
|---|---|
| Female | 245 |
| Male | 370 |
| Ethnicity (NIH/OMB)(Participants) | Atezolizumab |
|---|---|
| Hispanic or Latino | 93 |
| Not Hispanic or Latino | 509 |
| Unknown or Not Reported | 13 |
| Race (NIH/OMB)(Participants) | Atezolizumab |
|---|---|
| American Indian or Alaska Native | 44 |
| Asian | 76 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 4 |
| White | 483 |
| More than one race | 5 |
| Unknown or Not Reported | 2 |
| Region(Participants) | Atezolizumab |
|---|---|
| EMEA (Europe, the Middle East, and Africa) | 455 |
| Asia | 70 |
| LATAM (Latin America) | 90 |
| ECOG Performance Status(Participants) | Atezolizumab |
|---|---|
| ECOG performance status 0 (fully active) | 193 |
| ECOG performance status 1 (restricted in physically strenuous activity) | 361 |
| ECOG performance status 2 (ambulatory and capable of selfcare; unable to carry out work activities) | 61 |
| Smoking Status(Participants) | Atezolizumab |
|---|---|
| Never | 127 |
| Current | 115 |
| Previous | 373 |
| eGFR (mL/min/1.73 m^2) at baseline(Participants) | Atezolizumab |
|---|---|
| 15-<30 | 2 |
| 30-<60 | 77 |
| 60-<90 | 251 |
| >=90 | 283 |
| Missing | 2 |
Showing the first 100 of 111 sites across 24 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2017 to primary completion in Apr 2022, 53 months.
Results were first posted in Jan 2025, 2 years 9 months after primary completion.
Of 43 phase 4 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 48. This study's 53 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Atezolizumab
Carcinoma, Non-Small-Cell Lung →