A Phase 3 interventional study of Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody and Placebo Comparator in Non-Small-Cell Lung, sponsored by Hoffmann-La Roche. Completed at 117 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.
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.
Counted across the registry records on this site, refreshed daily.
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.
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 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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
Neoadjuvant treatment will consist of 4 cycles; atezolizumab + platinum-based chemotherapy Platinum-based chemotherapy may include: * carboplatin + pemetrexed * carboplatin + nab-paclitaxel * cisplatin + pemetrexed * cisplatin + gemcitabine Post-operative adjuvant treatment will consist of 16-cycles of atezolizumab
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody · Drug: Nab-paclitaxel · Drug: Pemetrexed · Drug: Carboplatin · Drug: Cisplatin · Drug: Gemcitabine
Neoadjuvant treatment will consist of 4 cycles; placebo + platinum-based chemotherapy Platinum-based chemotherapy may include: * carboplatin + pemetrexed * carboplatin + nab-paclitaxel * cisplatin + pemetrexed * cisplatin + gemcitabine Participants will receive best supportive care and monitoring after surgery
Drug: Placebo Comparator · Drug: Nab-paclitaxel · Drug: Pemetrexed · Drug: Carboplatin · Drug: Cisplatin · Drug: Gemcitabine
Atezolizumab will be administered as intravenous (IV) infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle (every 3 weeks) for 4 cycles during the neoadjuvant treatment phase Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) every 3 weeks for 16 cycles during the post-operative adjuvant phase
Also known as: Tecentriq
Placebo will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Nab-paclitaxel 100 mg/m\^2 will be administered intravenously on Days 1, 8, and 15 of each 21 day cycle for 4 cycles during the neoadjuvant treatment phase
Also known as: Abraxane
Pemetrexed 500 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Also known as: Alimta
Carboplatin initial target AUC of 6 mg/mL/min will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Cisplatin 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Gemcitabine 1250 mg/m\^2 will be administered intravenously on Day 1 and 8 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Also known as: Gemzar
Stage IIB-IIIB Wild-type (WT): Independent Review Facility (IRF)-Assessed Event-free Survival (EFS)
IRF-assessed EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the IRF. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions. Kaplan-Meier (K-M) method was used to estimate median IRF-assessed EFS.
Time frame: Up to 87.8 months
EGFR/ALK WT-ITT: IRF-assessed EFS
IRF-assessed EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the IRF. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median IRF-assessed EFS.
Time frame: Up to 87.8 months
Stage IIB-IIIB WT: IRF-assessed Pathological Complete Response (pCR) Rate
IRF-assessed pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
Time frame: At the time of surgery (from Day 114 to Day 144)
EGFR/ALK WT-ITT: IRF-assessed pCR Rate
IRF-assessed pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
Time frame: At the time of surgery (from Day 114 to Day 144)
Stage IIB-IIIB WT: IRF-assessed Major Pathological Response (MPR) Rate
IRF-assessed MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
Time frame: At the time of surgery (from Day 114 to Day 144)
EGFR/ALK WT-ITT: IRF-assessed MPR Rate
IRF-assessed MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
Time frame: At the time of surgery (from Day 114 to Day 144)
Stage IIB-IIIB WT: Investigator-assessed MPR Rate at the Time of Surgical Resection
MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
Time frame: At the time of surgery (from Day 114 to Day 144)
EGFR/ALK WT-ITT: Investigator-assessed MPR Rate at the Time of Surgical Resection
MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
Time frame: At the time of surgery (from Day 114 to Day 144)
Stage IIB-IIIB WT: Investigator-assessed pCR Rate at the Time of Surgical Resection
pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
Time frame: At the time of surgery (from Day 114 to Day 144)
EGFR/ALK WT-ITT: Investigator-assessed pCR Rate at the Time of Surgical Resection
pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
Time frame: At the time of surgery (from Day 114 to Day 144)
Stage IIB-IIIB WT: Investigator-Assessed Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as assessed by the investigator (confirmation not required) according to RECIST v1.1 during the neo-adjuvant treatment phase. CR was defined as the disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
Time frame: Up to 89.5 months
EGFR/ALK WT-ITT: Investigator-Assessed ORR
ORR was defined as the percentage of participants with a best overall response of CR or PR, as assessed by the investigator (confirmation not required) according to RECIST v1.1 during the neo-adjuvant treatment phase. CR was defined as the disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
Time frame: Up to 87.8 months
Stage IIB-IIIB WT: Overall Survival (OS)
OS was defined as the time from randomization to death from any cause during the course of the study. K-M method was used to estimate the median OS.
Time frame: Up to 87.8 months
EGFR/ALK WT-ITT: OS
OS was defined as the time from randomization to death from any cause during the course of the study. K-M method was used to estimate the median OS.
Time frame: Up to 87.8 months
Stage IIB-IIIB WT: Investigator-assessed EFS
EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median Investigator-assessed EFS.
Time frame: Up to 87.8 months
EGFR/ALK WT-ITT: Investigator-assessed EFS
EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median Investigator-assessed EFS.
Time frame: Up to 87.8 months
Stage IIB-IIIB WT: Investigator-assessed DFS
DFS was defined as the time from the first date of no disease (i.e., date of surgery) to local or distant recurrence (including occurrence of new primary NSCLC), or death due to any cause, whichever occurred first, as determined by the investigator during the adjuvant treatment and observation follow-up. DFS was analyzed only for participants who underwent surgery and had no evidence of residual NSCLC disease. K-M method was used to estimate median investigator-assessed DFS.
Time frame: From day of surgery (any time from Day 114 to Day 144) up to 87.8 months
EGFR/ALK WT-ITT: Investigator-assessed DFS
DFS was defined as the time from the first date of no disease (i.e., date of surgery) to local or distant recurrence (including occurrence of new primary NSCLC), or death due to any cause, whichever occurred first, as determined by the investigator during the adjuvant treatment and observation follow-up. DFS was analyzed only for participants who underwent surgery and had no evidence of residual NSCLC disease. K-M method was used to estimate median investigator-assessed DFS.
Time frame: From day of surgery (any time from Day 114 to Day 144) up to 87.8 months
Stage IIB-IIIB WT: 2-year and 3-year OS Rate During the Study
2-year and 3-year OS rates were defined as the percentage of participants who were alive 2 years and 3 years after randomization. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate the OS rate. Percentages have been rounded off.
Time frame: At Years 2 and 3
EGFR/ALK WT-ITT: 2-year and 3-year OS Rate During the Study
2-year and 3-year OS rates were defined as the percentage of participants who were alive 2 years and 3 years after randomization. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate the OS rate. Percentages have been rounded off.
Time frame: At Years 2 and 3
Stage IIB-IIIB WT: 2-year and 3-year IRF-assessed EFS Rate During the Study
2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. IRF-assessed EFS was defined as the time from randomization to the first occurrence of PD per RECIST v1.1 that precluded surgery, local or distant disease recurrence (including occurrence of new primary NSCLC), or death from any cause, as assessed by the IRF. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.
Time frame: At Years 2 and 3
EGFR/ALK WT-ITT: 2-year and 3-year IRF-assessed EFS Rate During the Study
2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. IRF-assessed EFS was defined as the time from randomization to the first occurrence of PD per RECIST v1.1 that precluded surgery, local or distant disease recurrence (including occurrence of new primary NSCLC), or death from any cause, as assessed by the IRF. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.
Time frame: At Years 2 and 3
Stage IIB-IIIB WT: 2-year and 3-year Investigator-assessed EFS Rate During the Study
2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.
Time frame: At Years 2 and 3
EGFR/ALK WT-ITT: 2-year and 3-year Investigator-assessed EFS Rate During the Study
2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.
Time frame: At Years 2 and 3
Stage IIB-IIIB WT: Change From Baseline in Health-related Quality-of-life (HRQoL) Scores, as Assessed Using Global Health Status (GHS)/Quality of Life (QoL) Subscale of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, \& social), 3 symptom scales (fatigue, nausea, vomiting, \& pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Participants were asked to answer the following questions for GHS/QoL: "How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?" These questions were scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a range of 0-100. High score on GHS/QoL scale indicates better HRQoL.
Time frame: Baseline; Day 1 Cycles 2,3,4,12,18,20; Pre-surgery (114 days); Surgery (144 days); Post-surgery (165 days); OFU visits 1-9 (every 2 cycles: cycles 5-21); Treatment/Follow-up discontinuation (621 days); SFU: every 3 months: Months 3-60 (1 Cycle=21 days)
EGFR/ALK WT-ITT: Change From Baseline in HRQoL Scores, as Assessed Using GHS/QoL Subscale of the EORTC QLQ-C30
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, \& social), 3 symptom scales (fatigue, nausea, vomiting, \& pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Participants were asked to answer the following questions: "How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?" These questions were scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to range of 0-100. High score on GHS/QoL scale indicates better HRQoL.
Time frame: Baseline; Day 1 Cycles 2,3,4,12,18,20; Pre-surgery (114 days); Surgery (144 days); Post-surgery (165 days); OFU visits 1-9 (every 2 cycles: cycles 5-21); Treatment/Follow-up discontinuation (621 days); SFU: every 3 months: Months 3-60 (1 Cycle=21 days)
Number of Participants With Adverse Events (AEs), and Serious Adverse Events (SAEs)
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any AE that met any of the following criteria: was fatal; was life-threatening; required or prolonged in-patient hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was a significant medical event in the investigator's judgment.
Time frame: Up to approximately 23.44 months
Number of Participants With Immune-mediated AEs
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants with immune-mediated AEs have been reported here.
Time frame: Up to approximately 23.44 months
Number of Participants With Surgical Delays
Participants were scheduled to undergo surgical resection of their tumor upon completion of 4 cycles of neo-adjuvant therapy. Prior to the surgery, the attending surgeon and medical oncologist assessed the participant to check if it was clinically feasible for them to undergo surgery (pre-surgery visit). Pre-surgery visit occurred within 30 days after the last dose of neo-adjuvant treatment, and surgery was performed within 30 days after the pre-surgery visit. Assessment of surgical delays were made by assessing the data entered in the electronic case report forms (eCRFs).
Time frame: Day of surgery (any time from Day 114 to Day 144) to approximately 3.2 months
Length of Surgical Delays
Time frame: Day of surgery (any time from Day 114 to Day 144) to approximately 3.2 months
Number of Participants With Operative and Post-operative Complications
Participants who underwent surgical resection of their tumor and had intraoperative or post-operative complications were reported.
Time frame: From day of surgery (up to approximately 144 days) up to end of SFU (up to approximately 19.7 months)
Number of Participants With Reasons for Surgical Cancellations
Participants who did not undergo surgical resection for various reasons have been reported here.
Time frame: From Day 114 (pre-surgery) to Day 144
Serum Concentration of Atezolizumab at Specified Timepoints
Time frame: Pre-dose on Day 1 of Cycles 1, 3, 5, 7, 11, and 19; 30 minutes post-dose on Day 1 of Cycles 1 and 5; Treatment discontinuation (TD) or OFU completion or early discontinuation (ED) (621 days); Predose on PD or disease recurrence visit (651 days)
Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response).
Time frame: Up to 20.44 months
A total of 451 participants with histologically or cytologically confirmed resectable Stage II, IIIA, or select IIIB (T3N2 only) non-small-cell lung cancer (NSCLC) took part in the study at 120 investigative sites across 24 countries from 24 April 2018 to 31 December 2025.
| Milestone | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Started | 225 | 226 |
| Safety-evaluable (se) population | 224 | 226 |
| Completed | 193 | 181 |
| Not completed | 32 | 45 |
| Withdrew: Adverse event | 12 | 18 |
| Withdrew: Death | 2 | 6 |
| Withdrew: Physician decision | 7 | 13 |
| Withdrew: Progressive disease | 4 | 3 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Symptomatic deterioration | 2 | 0 |
| Withdrew: Withdrawal by subject | 5 | 4 |
| Milestone | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Started | 179 | 175 |
| Completed | 111 | 100 |
| Not completed | 68 | 75 |
| Withdrew: Adverse event | 0 | 26 |
| Withdrew: Death | 2 | 4 |
| Withdrew: Physician decision | 1 | 5 |
| Withdrew: Progressive disease | 43 | 26 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 8 | 9 |
| Withdrew: Reason not specified | 13 | 5 |
| Milestone | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Started | 213 | 213 |
| Completed | 0 | 0 |
| Not completed | 213 | 213 |
| Withdrew: Death | 87 | 70 |
| Withdrew: Lost to follow-up | 6 | 8 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Withdrawal by subject | 20 | 16 |
| Withdrew: Study ended by sponsor | 99 | 117 |
| Withdrew: Reason not specified | 0 | 1 |
IRF-assessed EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the IRF. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions. Kaplan-Meier (K-M) method was used to estimate median IRF-assessed EFS.
| months | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Stage IIB-IIIB Wild-type (WT): Independent Review Facility (IRF)-Assessed Event-free Survival (EFS) | 34.92 (24.57 to 63.80) | 62.78 (41.43 to NA) |
IRF-assessed EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the IRF. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median IRF-assessed EFS.
| months | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| EGFR/ALK WT-ITT: IRF-assessed EFS | 43.86 (28.02 to 63.80) | 67.15 (49.15 to NA) |
IRF-assessed pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Stage IIB-IIIB WT: IRF-assessed Pathological Complete Response (pCR) Rate | 8.5 (5.00 to 13.20) | 29.6 (23.30 to 36.51) |
IRF-assessed pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| EGFR/ALK WT-ITT: IRF-assessed pCR Rate | 8.6 (5.26 to 13.10) | 30.6 (24.56 to 37.16) |
IRF-assessed MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Stage IIB-IIIB WT: IRF-assessed Major Pathological Response (MPR) Rate | 24.4 (18.61 to 30.92) | 53.6 (46.33 to 60.71) |
IRF-assessed MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the central pathology laboratory. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| EGFR/ALK WT-ITT: IRF-assessed MPR Rate | 24.9 (19.33 to 31.13) | 54.3 (47.49 to 61.06) |
MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Stage IIB-IIIB WT: Investigator-assessed MPR Rate at the Time of Surgical Resection | 23.4 (17.72 to 29.85) | 48.0 (40.79 to 55.19) |
MPR rate was defined as the percentage of participants with ≤ 10% residual viable tumor cells in the primary tumor at the time of surgical resection, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| EGFR/ALK WT-ITT: Investigator-assessed MPR Rate at the Time of Surgical Resection | 24.0 (18.51 to 30.17) | 49.3 (42.51 to 56.13) |
pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Stage IIB-IIIB WT: Investigator-assessed pCR Rate at the Time of Surgical Resection | 5.5 (2.76 to 9.58) | 18.9 (13.65 to 25.07) |
pCR rate was defined as the percentage of participants with an absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes, as assessed by the investigator site pathologist after surgical resection of the primary tumor. Participants who did not meet this criteria, including those who did not undergo surgical resection were considered as non-responders. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| EGFR/ALK WT-ITT: Investigator-assessed pCR Rate at the Time of Surgical Resection | 5.4 (2.84 to 9.29) | 18.3 (13.38 to 24.03) |
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as assessed by the investigator (confirmation not required) according to RECIST v1.1 during the neo-adjuvant treatment phase. CR was defined as the disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Stage IIB-IIIB WT: Investigator-Assessed Objective Response Rate (ORR) | 54.2 (47.07 to 61.26) | 68.4 (61.36 to 74.81) |
ORR was defined as the percentage of participants with a best overall response of CR or PR, as assessed by the investigator (confirmation not required) according to RECIST v1.1 during the neo-adjuvant treatment phase. CR was defined as the disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| EGFR/ALK WT-ITT: Investigator-Assessed ORR | 56.1 (49.29 to 62.76) | 68.0 (61.42 to 74.16) |
OS was defined as the time from randomization to death from any cause during the course of the study. K-M method was used to estimate the median OS.
| months | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Stage IIB-IIIB WT: Overall Survival (OS) | 81.74 (66.79 to NA) | NA (NA to NA) |
OS was defined as the time from randomization to death from any cause during the course of the study. K-M method was used to estimate the median OS.
| months | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| EGFR/ALK WT-ITT: OS | 81.74 (63.80 to NA) | NA (NA to NA) |
EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median Investigator-assessed EFS.
| months | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Stage IIB-IIIB WT: Investigator-assessed EFS | 34.56 (24.18 to 51.58) | 62.78 (41.76 to NA) |
EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median Investigator-assessed EFS.
| months | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| EGFR/ALK WT-ITT: Investigator-assessed EFS | 36.53 (26.97 to 60.75) | 64.95 (47.18 to NA) |
DFS was defined as the time from the first date of no disease (i.e., date of surgery) to local or distant recurrence (including occurrence of new primary NSCLC), or death due to any cause, whichever occurred first, as determined by the investigator during the adjuvant treatment and observation follow-up. DFS was analyzed only for participants who underwent surgery and had no evidence of residual NSCLC disease. K-M method was used to estimate median investigator-assessed DFS.
| months | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Stage IIB-IIIB WT: Investigator-assessed DFS | 47.74 (24.15 to 66.00) | 82.69 (53.62 to NA) |
DFS was defined as the time from the first date of no disease (i.e., date of surgery) to local or distant recurrence (including occurrence of new primary NSCLC), or death due to any cause, whichever occurred first, as determined by the investigator during the adjuvant treatment and observation follow-up. DFS was analyzed only for participants who underwent surgery and had no evidence of residual NSCLC disease. K-M method was used to estimate median investigator-assessed DFS.
| months | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| EGFR/ALK WT-ITT: Investigator-assessed DFS | 54.41 (30.23 to 66.00) | 82.69 (54.31 to NA) |
2-year and 3-year OS rates were defined as the percentage of participants who were alive 2 years and 3 years after randomization. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate the OS rate. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Year 2 | 79.86 (74.05 to 85.67) | 84.17 (78.98 to 89.37) |
| Year 3 | 70.19 (63.51 to 76.87) | 78.19 (72.27 to 84.10) |
2-year and 3-year OS rates were defined as the percentage of participants who were alive 2 years and 3 years after randomization. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate the OS rate. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Year 2 | 80.85 (75.44 to 86.26) | 84.02 (79.10 to 88.95) |
| Year 3 | 71.16 (64.88 to 77.44) | 78.22 (72.64 to 83.79) |
2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. IRF-assessed EFS was defined as the time from randomization to the first occurrence of PD per RECIST v1.1 that precluded surgery, local or distant disease recurrence (including occurrence of new primary NSCLC), or death from any cause, as assessed by the IRF. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Year 2 | 58.78 (51.56 to 66.01) | 63.50 (56.51 to 70.49) |
| Year 3 | 49.39 (42.00 to 56.79) | 58.90 (51.73 to 66.07) |
2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. IRF-assessed EFS was defined as the time from randomization to the first occurrence of PD per RECIST v1.1 that precluded surgery, local or distant disease recurrence (including occurrence of new primary NSCLC), or death from any cause, as assessed by the IRF. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Year 2 | 60.74 (53.93 to 67.55) | 65.19 (58.68 to 71.70) |
| Year 3 | 51.77 (44.76 to 58.78) | 61.13 (54.44 to 67.81) |
2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Year 2 | 57.36 (50.17 to 64.54) | 65.69 (58.86 to 72.52) |
| Year 3 | 47.73 (40.44 to 55.02) | 61.16 (54.12 to 68.21) |
2-year and 3-year EFS rates were defined as the percentage of participants who remained event-free 2 years and 3 years after randomization. EFS was defined as the time from the date of randomization to any of the following events, whichever occurred first: PD per RECIST v1.1 that precluded surgery; local or distant disease recurrence (including occurrence of new primary NSCLC); or death due to any cause, as assessed by the investigator. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the EFS rates. Percentages have been rounded off.
| percentage of participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Year 2 | 59.41 (52.62 to 66.19) | 67.11 (60.74 to 73.48) |
| Year 3 | 50.21 (43.28 to 57.15) | 63.11 (56.54 to 69.68) |
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, \& social), 3 symptom scales (fatigue, nausea, vomiting, \& pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Participants were asked to answer the following questions for GHS/QoL: "How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?" These questions were scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a range of 0-100. High score on GHS/QoL scale indicates better HRQoL.
| units on a scale | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Baseline | 72.69 ± 20.33 | 72.39 ± 20.53 |
| Change on Day 1 of Cycle 2 | -0.05 ± 18.07 | -1.08 ± 19.42 |
| Change on Day 1 of Cycle 3 | -0.71 ± 19.52 | -1.70 ± 21.00 |
| Change on Day 1 of Cycle 4 | -4.29 ± 21.48 | -2.44 ± 21.36 |
| Change at Pre-surgery | -4.55 ± 22.44 | -2.62 ± 22.70 |
| Change at Thoracic Surgery | -14.10 ± 20.80 | 7.78 ± 24.49 |
| Change at Post-surgery | -13.77 ± 24.13 | -11.68 ± 25.41 |
| Change at OFU Visit 1 | -4.93 ± 21.36 | -4.61 ± 23.21 |
| Change at OFU Visit 2 | -1.53 ± 21.48 | -0.41 ± 20.63 |
| Change at OFU Visit 3 | 0.43 ± 22.95 | 1.65 ± 20.33 |
| Change at OFU Visit 4 | 0.44 ± 19.07 | -0.20 ± 20.76 |
| Change on Day 1 of Cycle 12 | — | 8.33 ± NA |
| Change at OFU Visit 5 | -1.76 ± 21.15 | -0.98 ± 22.29 |
| Change at OFU Visit 6 | 2.08 ± 18.44 | 0.51 ± 21.50 |
| Change at OFU Visit 7 | 2.38 ± 19.26 | 1.80 ± 19.04 |
| Change on Day 1 of Cycle 18 | — | 8.33 ± NA |
| Change at OFU Visit 8 | 3.07 ± 20.23 | 1.48 ± 20.92 |
| Change on Day 1 of Cycle 20 | — | 0.00 ± NA |
| Change at OFU Visit 9 | -8.33 ± 11.79 | — |
| Change at Treatment/Follow-up Discontinuation | -4.50 ± 23.73 | -3.13 ± 23.39 |
| Change at SFU Month 3 | -3.80 ± 25.81 | -1.58 ± 25.91 |
| Change at SFU Month 6 | -3.17 ± 24.33 | 1.32 ± 25.24 |
| Change at SFU Month 9 | -0.61 ± 23.45 | 0.51 ± 25.54 |
| Change at SFU Month 12 | -1.84 ± 30.09 | 0.45 ± 22.45 |
| Change at SFU Month 15 | -0.22 ± 27.02 | -0.29 ± 24.63 |
| Change at SFU Month 18 | 6.67 ± 25.28 | 4.93 ± 24.23 |
| Change at SFU Month 21 | 0.76 ± 28.16 | 6.53 ± 23.25 |
| Change at SFU Month 24 | 13.73 ± 30.89 | 6.79 ± 22.17 |
| Change at SFU Month 27 | 4.55 ± 41.22 | 3.75 ± 29.55 |
| Change at SFU Month 30 | 7.41 ± 35.22 | 12.50 ± 21.54 |
| Change at SFU Month 33 | 22.22 ± 22.44 | 7.35 ± 28.85 |
| Change at SFU Month 36 | 9.72 ± 31.37 | 13.33 ± 22.29 |
| Change at SFU Month 39 | -4.17 ± 53.03 | 9.26 ± 28.09 |
| Change at SFU Month 42 | -3.33 ± 50.89 | 12.50 ± 23.42 |
| Change at SFU Month 45 | -25.00 ± 58.33 | 13.89 ± 25.09 |
| Change at SFU Month 48 | 8.33 ± 35.36 | 25.00 ± 44.10 |
| Change at SFU Month 51 | — | -33.33 ± NA |
| Change at SFU Month 54 | 16.67 ± NA | -33.33 ± NA |
| Change at SFU Month 57 | -66.67 ± NA | -33.33 ± NA |
| Change at SFU Month 60 | -66.67 ± NA | — |
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, \& social), 3 symptom scales (fatigue, nausea, vomiting, \& pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Participants were asked to answer the following questions: "How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?" These questions were scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to range of 0-100. High score on GHS/QoL scale indicates better HRQoL.
| units on a scale | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Baseline | 72.43 ± 20.21 | 72.78 ± 20.32 |
| Change on Day 1 of Cycle 2 | 0.37 ± 18.08 | -1.33 ± 19.31 |
| Change on Day 1 of Cycle 3 | -0.60 ± 19.27 | -2.07 ± 21.78 |
| Change on Day 1 of Cycle 4 | -3.62 ± 21.19 | -2.67 ± 21.61 |
| Change at Pre-surgery | -4.10 ± 22.36 | -2.47 ± 22.75 |
| Change at Thoracic Surgery | -12.50 ± 20.87 | 7.78 ± 24.49 |
| Change at Post-surgery | -13.17 ± 23.79 | -12.36 ± 25.92 |
| Change at OFU Visit 1 | -5.37 ± 20.76 | -4.82 ± 23.07 |
| Change at OFU Visit 2 | -2.38 ± 21.57 | -0.61 ± 20.84 |
| Change at OFU Visit 3 | 0.56 ± 22.52 | 1.69 ± 20.38 |
| Change at OFU Visit 4 | -0.20 ± 19.90 | -0.42 ± 20.57 |
| Change on Day 1 of Cycle 12 | — | 8.33 ± NA |
| Change at OFU Visit 5 | -1.92 ± 21.89 | -1.54 ± 22.49 |
| Change at OFU Visit 6 | 1.64 ± 19.59 | 0.32 ± 21.28 |
| Change at OFU Visit 7 | 1.95 ± 20.35 | 0.65 ± 18.98 |
| Change on Day 1 of Cycle 18 | — | 8.33 ± NA |
| Change at OFU Visit 8 | 2.73 ± 20.66 | 0.89 ± 20.58 |
| Change on Day 1 of Cycle 20 | — | 0.00 ± NA |
| Change at OFU Visit 9 | -8.33 ± 11.79 | — |
| Change at Treatment/Follow-up Discontinuation | -4.81 ± 22.90 | -3.06 ± 22.87 |
| Change at SFU Month 3 | -3.22 ± 25.47 | -1.75 ± 24.84 |
| Change at SFU Month 6 | -2.64 ± 23.99 | 1.03 ± 24.42 |
| Change at SFU Month 9 | -1.25 ± 23.65 | 0.88 ± 25.54 |
| Change at SFU Month 12 | -1.90 ± 28.49 | 0.49 ± 21.38 |
| Change at SFU Month 15 | 0.87 ± 25.68 | 0.00 ± 23.53 |
| Change at SFU Month 18 | 6.90 ± 23.53 | 4.68 ± 23.41 |
| Change at SFU Month 21 | 0.72 ± 27.51 | 5.62 ± 22.55 |
| Change at SFU Month 24 | 13.43 ± 30.00 | 5.91 ± 21.96 |
| Change at SFU Month 27 | 4.55 ± 41.22 | 2.90 ± 28.49 |
| Change at SFU Month 30 | 7.41 ± 35.22 | 11.36 ± 20.98 |
| Change at SFU Month 33 | 22.22 ± 22.44 | 7.41 ± 27.99 |
| Change at SFU Month 36 | 9.72 ± 31.37 | 12.88 ± 21.20 |
| Change at SFU Month 39 | -4.17 ± 53.03 | 8.33 ± 26.64 |
| Change at SFU Month 42 | -3.33 ± 50.89 | 12.50 ± 23.42 |
| Change at SFU Month 45 | -25.00 ± 58.33 | 10.71 ± 24.40 |
| Change at SFU Month 48 | 8.33 ± 35.36 | 18.06 ± 35.91 |
| Change at SFU Month 51 | — | 2.78 ± 33.68 |
| Change at SFU Month 54 | 16.67 ± NA | -33.33 ± NA |
| Change at SFU Month 57 | -66.67 ± NA | -33.33 ± NA |
| Change at SFU Month 60 | -66.67 ± NA | — |
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any AE that met any of the following criteria: was fatal; was life-threatening; required or prolonged in-patient hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was a significant medical event in the investigator's judgment.
| Participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| AEs | 222 | 226 |
| SAEs | 72 | 105 |
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants with immune-mediated AEs have been reported here.
| Participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Immune-mediated Rash | 41 | 83 |
| Immune-mediated Hepatitis (Diagnosis & Lab Abnormalities) | 28 | 38 |
| Immune-mediated Hepatitis (Lab Abnormalities) | 28 | 35 |
| Immune-mediated Hypothyroidism | 5 | 33 |
| Immune-Mediated Pneumonitis | 7 | 22 |
| Immune-Mediated Hyperthyroidism | 6 | 21 |
| Immune-Mediated Colitis | 3 | 6 |
| Immune-Mediated Hepatitis (Diagnosis) | 1 | 5 |
| Immune-Mediated Pancreatitis | 0 | 5 |
| Immune-Mediated Adrenal Insufficiency | 0 | 3 |
| Immune-Mediated Pericardial Disorders | 2 | 1 |
| Immune-Mediated Severe Cutaneous Reactions | 1 | 2 |
| Immune-Mediated Diabetes Mellitus | 0 | 2 |
| Immune-Mediated Myositis (Myositis+Rhabdomyolysis) | 0 | 2 |
| Immune-Mediated Nephritis | 1 | 1 |
| Immune-Mediated Vasculitis | 1 | 1 |
| Immune-Mediated Hypophysitis | 0 | 1 |
| Immune-Mediated Myositis | 0 | 1 |
| Other Immune-Mediated Ocular Inflammatory Toxicity | 0 | 1 |
Participants were scheduled to undergo surgical resection of their tumor upon completion of 4 cycles of neo-adjuvant therapy. Prior to the surgery, the attending surgeon and medical oncologist assessed the participant to check if it was clinically feasible for them to undergo surgery (pre-surgery visit). Pre-surgery visit occurred within 30 days after the last dose of neo-adjuvant treatment, and surgery was performed within 30 days after the pre-surgery visit. Assessment of surgical delays were made by assessing the data entered in the electronic case report forms (eCRFs).
| Participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Number of Participants With Surgical Delays | 25 | 21 |
| weeks | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Length of Surgical Delays | 1.3 (0 to 14) | 1.0 (0 to 14) |
Participants who underwent surgical resection of their tumor and had intraoperative or post-operative complications were reported.
| Participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Intraoperative Complications | 10 | 7 |
| Post-operative Complications | 17 | 19 |
Participants who did not undergo surgical resection for various reasons have been reported here.
| Participants | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| Participant Withdrawal | 4 | 4 |
| PD | 9 | 5 |
| AEs | 5 | 8 |
| Other | 5 | 8 |
| micrograms per milliliter (µg/mL) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|
| Pre-dose on Day 1 of Cycle 1 | NA ± NA |
| 30 minutes post-dose on Day 1 of Cycle 1 | 394 ± 25.1 |
| Pre-dose on Day 1 of Cycle 3 | 116 ± 41.0 |
| Pre-dose on Day 1 of Cycle 5 | 10.1 ± 1537.7 |
| 30 minutes post-dose on Day 1 of Cycle 5 | 412 ± 73.5 |
| Pre-dose on Day 1 of Cycle 7 | 145 ± 67.1 |
| Pre-dose on Day 1 of Cycle 11 | 202 ± 42.9 |
| Pre-dose on Day 1 of Cycle 19 | 211 ± 40.1 |
| TD or OFU completion or ED | 96.5 ± 522.7 |
| PD or Disease Recurrence | 11.9 ± 121030.2 |
Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response).
| Participants | Atezolizumab + Platinum-based Chemotherapy |
|---|---|
| Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab | 46 |
Collected over SAEs and Other AEs: Up to approximately 23.44 months All-cause Mortality: Up to 89.5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + Platinum-based Chemotherapy (Control) | 92/224 (41.1%) | 72/224 (32.1%) | 217/224 (96.9%) |
| Atezolizumab + Platinum-based Chemotherapy | 81/226 (35.8%) | 105/226 (46.5%) | 224/226 (99.1%) |
| Event | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| PneumoniaInfections and infestations | 10/224 | 14/226 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/224 | 8/226 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/224 | 7/226 |
| Neutrophil count decreasedInvestigations | 6/224 | 2/226 |
| Atrial fibrillationCardiac disorders | 5/224 | 5/226 |
| AnaemiaBlood and lymphatic system disorders | 3/224 | 5/226 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/224 | 5/226 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/224 | 5/226 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 4/224 | 1/226 |
| Pulmonary fistulaRespiratory, thoracic and mediastinal disorders | 4/224 | 0/226 |
| Event | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 108/224 | 94/226 |
| NauseaGastrointestinal disorders | 90/224 | 104/226 |
| FatigueGeneral disorders | 73/224 | 84/226 |
| ConstipationGastrointestinal disorders | 73/224 | 82/226 |
| NeutropeniaBlood and lymphatic system disorders | 75/224 | 74/226 |
| AlopeciaSkin and subcutaneous tissue disorders | 66/224 | 56/226 |
| DiarrhoeaGastrointestinal disorders | 47/224 | 63/226 |
| Procedural painInjury, poisoning and procedural complications | 52/224 | 60/226 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 56/224 | 43/226 |
| Decreased appetiteMetabolism and nutrition disorders | 46/224 | 56/226 |
Intent-to-treat (ITT) population included all randomized participants, regardless of receipt of the assigned treatment.
| Age, Continuous(years) | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy | Total |
|---|---|---|---|
| Mean | 63.8 ± 9.3 | 64.0 ± 8.2 | 63.9 ± 8.7 |
| Sex: Female, Male(Participants) | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy | Total |
|---|---|---|---|
| Female | 71 | 68 | 139 |
| Male | 154 | 158 | 312 |
| Ethnicity (NIH/OMB)(Participants) | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy | Total |
|---|---|---|---|
| Hispanic or Latino | 12 | 10 | 22 |
| Not Hispanic or Latino | 197 | 198 | 395 |
| Unknown or Not Reported | 16 | 18 | 34 |
| Race (NIH/OMB)(Participants) | Placebo + Platinum-based Chemotherapy (Control) | Atezolizumab + Platinum-based Chemotherapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 30 | 39 | 69 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 7 | 9 | 16 |
| White | 170 | 161 | 331 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 18 | 16 | 34 |
Showing the first 100 of 117 sites across 24 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Ran from Apr 2018 to primary completion in Oct 2025, 89 months.
Results were first posted in Oct 2026, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atezolizumab