A Phase 2 interventional study of Pembrolizumab in Non Small Cell Lung Cancer, sponsored by Spanish Lung Cancer Group. Completed at 12 sites in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Spanish Lung Cancer Group · Phase 2, Interventional, and Treatment
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Among 127 studies testing pembrolizumab in Carcinoma, Non-Small-Cell Lung — 29 open to participants now, 48 under way, 13 of them phase 3. pembrolizumab · Carcinoma, Non-Small-Cell Lung.
Among the 127 studies testing pembrolizumab in Carcinoma, Non-Small-Cell Lung, this one is the 59th largest by enrollment, is one of 15 that started in 2017, is one of 65 in phase 2, and was the 43rd 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 →29 of the 127 studies testing pembrolizumab in Carcinoma, Non-Small-Cell Lung are open now, in 10 countries. Recruiting first, the newest first:
University of Chicago · Sites in United States
Ages 18+
EuroCityClinic LLC · Sites in Russia
Ages 18+
AHS Cancer Control Alberta · Sites in Canada
Ages 18+
UNICANCER · Sites in France
Ages 18+
Hunan Province Tumor Hospital · Sites in China
Ages 18–75
By country, each count listing its studies:
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. 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: 70 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, pembrolizumab is the treatment under test here. Read study by study →
127 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 29 · Phase 2 74 · Phase 3 30 · Phase 4 1
First in 2013; this study’s year is marked. 15 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 83 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 65 across the 127 interventional studies. Of the 67 that completed or were terminated, 56 (84%) have results posted.
This tab as a report to print or save as PDF → With an account.
39 of 127 have an industry lead sponsor. The 10 most frequent:
Spanish Lung Cancer Group is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
17 studies in Carcinoma, Non-Small-Cell Lung by Spanish Lung Cancer Group: none open now, none under way, none of them phase 3. Of 17 finished, 10 (59%) have results posted.
Among the 17 studies in Carcinoma, Non-Small-Cell Lung by Spanish Lung Cancer Group, this one is the 8th largest by enrollment of the 13 interventional ones that give a count, is one of 3 that started in 2017, is one of 6 in phase 2, and was the 14th registered.
Spanish Lung Cancer Group’s Carcinoma, Non-Small-Cell Lung studies by the year they started, since 1999.
13 of the studies testing pembrolizumab in Carcinoma, Non-Small-Cell Lung that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07162883Phase 3Qilu Pharmaceutical Co., Ltd.Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC) | 2026-12-31 |
| NCT04380636Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) | 2027-05-05 |
| NCT05085028Phase 3Imperial College LondonA Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) | 2027-05-31 |
| NCT05493566Emory UniversityLow-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer | 2027-01-07 |
| NCT06388031Peking Union Medical College HospitalICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI | 2027-01-10 |
Add all 13 to your calendar (.ics) → With an account.
Among the 127 studies testing pembrolizumab in Carcinoma, Non-Small-Cell Lung, from their registry updates:
Among Spanish Lung Cancer Group’s 17 in Carcinoma, Non-Small-Cell Lung:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a multi-center phase II trial of intravenous (IV) Pembrolizumab MK-3475 in subjects older than 70 years with advanced Non-small cell Lung Cancer (NSCLC) expressing Programmed death-ligand 1 (PD-L1). 82 patients will be enrolled in this trial to examine the efficacy, the impact on geriatric assessments, the quality of life and the self-reported outcomes.
Subjects will receive MK-3475 at a fixed dose of 200 mg every 3 weeks (Q3W) (Figure 1). Subjects will be evaluated every 9 weeks (63 ± 7 days) with radiographic imaging to assess response to treatment. QoL and Self-reported Health Questionnaires, as well as geriatric follow-up will be performed at the same intervals. Investigators will make all treatment-based decisions using immune-related Response Criteria (irRC). However, for determination of overall response rate (ORR) and progression-free survival (PFS), the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be used. Adverse events will be monitored throughout the trial and graded in severity according to the guidelines outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Treatment with MK-3475 will continue until two years of therapy have been administered, documented disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, noncompliance with trial treatment or procedure requirements, or administrative reasons.
After the end of treatment, each subject will be followed for a minimum of 30 days for adverse event monitoring (serious adverse events will be collected for up to 90 days after the end of treatment unless the subject starts a new anticancer therapy between days 31 and 90). Subjects will have post-treatment follow-up for disease status, including initiating a non-study cancer treatment and experiencing disease progression, until death, withdrawing consent, or becoming lost to follow-up.
Participation in this trial will be dependent upon supplying tumor tissue from a newly obtained formalin-fixed specimen from locations not radiated prior to biopsy. The specimen will be evaluated at a central laboratory facility for expression status of Programmed death-ligand 1(PD-L1) in a prospective manner. Only subjects whose tumors express Programmed death-ligand 1(PD-L1) as determined by the central laboratory facility will be eligible for inclusion in this study.
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:
Has any geriatric 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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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 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.
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.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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 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.
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.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
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.
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.
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.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
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.
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.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Drug: Pembrolizumab
Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Also known as: KEYTRUDA
Overall Survival
Defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.
Time frame: From the date of inclusion of the first patient to until end of follow up, up to 36 months.
Changes in Health-related Quality of Life With Lung Cancer Symptom Scale
To evaluate changes in health-related quality of life in responder and non-responder patients older than 70 years with advanced non-small cell lung cancer. QLQ-C30 Quality of Life Questionnaire. The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. All EORTC QLQ-C30 scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom- atology
Time frame: Beginning of cycle 1 (week 1) and beginning of cycle 18 (week 54) (each cycle is 3 weeks)
Impact on Functional Assessments Measured With Barthel Scale
To evaluate the impact on functional geriatric assessments of patients older than 70 years with advanced non-small cell lung cancer. The Barthel Index assesses activities in two major categories: Personal care and mobility. The personal care items include tasks such as drinking from a cup, dressing, grooming, bathing, and bowel and bladder continence. The scoring is as follows: scores of 0-20 indicate "total" dependency. scores of 21-60 indicate "severe" dependency. scores of 61-90 indicate "moderate" dependency. scores of 91-99 indicate "slight" dependency, score of 100 indicate independent.
Time frame: Beginning of cycle 1 (week 1), beginning of cycle 4 (week 12), beginning of cycle 7 (week 21), beginning of cycle 10 (week 30), beginning of cycle 13 (week 39), beginning of cycle 16 (week 48) and beginning of cycle 18 (week 54) (each cycle is 3 weeks)
Progression-free Survival (PFS)
To describe Progression-free Survival (PFS), according to RECIST criteria v. 1.1 of the first-line treatment with pembrolizumab (MK-3475) in elderly patients with advanced NSCLC. PFS defined as the length of time from the date of randomization to the date of the first documented progression of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From the inclusion date in the study until first progression or end of follow up, up to 36 months
Overall Survival Rate at 2 Years.
To evaluate the overall survival percentage of the patients included at two years
Time frame: From the date of inclusion of the first patient until two years follow up visit, up to 24 months
OS for Patients With a PD-L1 Under 50%
Defined as the length of time from the date of the start of the treatment that patients diagnosed with the disease and PD¨-L1 under 50% are still alive.
Time frame: From the initiation of treatment until end of follow up, up to 36 months
OS for Patients With a PD-L1 Greater Than or Equal to 50%
Defined as the length of time from the start of the treatment that patients diagnosed with the disease and PD-L1 greater than or equal to 50% are still alive.
Time frame: From the initiation of treatment until end of follow up, up to 36 months
| Milestone | Pembrolizumab Arm |
|---|---|
| Started | 83 |
| Completed | 74 |
| Not completed | 9 |
| Withdrew: Death | 1 |
| Withdrew: Did not meet inclusion criteria | 8 |
Defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.
| Months | Pembrolizumab Arm |
|---|---|
| Overall Survival | 19.2 (11.3 to 25.5) |
To evaluate changes in health-related quality of life in responder and non-responder patients older than 70 years with advanced non-small cell lung cancer. QLQ-C30 Quality of Life Questionnaire. The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. All EORTC QLQ-C30 scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom- atology
| units on a scale | Pembrolizumab Arm |
|---|---|
| At the beginning of the first cycle | 66.7 (16.7 to 100) |
| At the beginning of the eighteenth cycle | 92.3 (72.3 to 100) |
To evaluate the impact on functional geriatric assessments of patients older than 70 years with advanced non-small cell lung cancer. The Barthel Index assesses activities in two major categories: Personal care and mobility. The personal care items include tasks such as drinking from a cup, dressing, grooming, bathing, and bowel and bladder continence. The scoring is as follows: scores of 0-20 indicate "total" dependency. scores of 21-60 indicate "severe" dependency. scores of 61-90 indicate "moderate" dependency. scores of 91-99 indicate "slight" dependency, score of 100 indicate independent.
| units on a scale | Pembrolizumab Arm |
|---|---|
| At the beginning of Cycle 1 | 100 (50 to 100) |
| At the beginning of Cycle 4 | 100 (76 to 100) |
| At the beginning of Cycle 7 | 100 (65 to 100) |
| At the beginning of Cycle 10 | 100 (75 to 100) |
| At the beginning of Cycle 13 | 100 (70 to 100) |
| At the beginning of Cycle 16 | 100 (58 to 100) |
| At the beginning of Cycle 18 | 97 (90 to 100) |
To describe Progression-free Survival (PFS), according to RECIST criteria v. 1.1 of the first-line treatment with pembrolizumab (MK-3475) in elderly patients with advanced NSCLC. PFS defined as the length of time from the date of randomization to the date of the first documented progression of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| Months | Pembrolizumab Arm |
|---|---|
| Progression-free Survival (PFS) | 6.1 (4.6 to 8.6) |
To evaluate the overall survival percentage of the patients included at two years
| percentage of participants | Pembrolizumab Arm |
|---|---|
| Overall Survival Rate at 2 Years. | 40.2 (28.6 to 51.5) |
Defined as the length of time from the date of the start of the treatment that patients diagnosed with the disease and PD¨-L1 under 50% are still alive.
| Months | Pembrolizumab Arm |
|---|---|
| OS for Patients With a PD-L1 Under 50% | 16.5 (6.8 to 24.6) |
Defined as the length of time from the start of the treatment that patients diagnosed with the disease and PD-L1 greater than or equal to 50% are still alive.
| Months | Pembrolizumab Arm |
|---|---|
| OS for Patients With a PD-L1 Greater Than or Equal to 50% | 23.3 (14.8 to 36) |
Collected over 36 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab Arm | 46/74 (62.2%) | 46/74 (62.2%) | 59/74 (79.7%) |
| Event | Pembrolizumab Arm |
|---|---|
| Progression diseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 36/74 |
| Other causes of deathGeneral disorders | 10/74 |
| Event | Pembrolizumab Arm |
|---|---|
| FatigueGeneral disorders | 23/74 |
| PruritusSkin and subcutaneous tissue disorders | 19/74 |
| DiarrhoeaGastrointestinal disorders | 14/74 |
| Dry skinSkin and subcutaneous tissue disorders | 12/74 |
| AnorexiaMetabolism and nutrition disorders | 12/74 |
| RashSkin and subcutaneous tissue disorders | 11/74 |
| HyperthyroidismEndocrine disorders | 9/74 |
| HypothyroidismSkin and subcutaneous tissue disorders | 7/74 |
| Platelet count decreasedInvestigations | 6/74 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 6/74 |
We performed the analyses on the intention-to-treat (ITT) population.
| Age, Continuous(years) | Pembrolizumab Arm |
|---|---|
| Mean | 78.1 ± 5.50 |
| Sex: Female, Male(Participants) | Pembrolizumab Arm |
|---|---|
| Female | 10 |
| Male | 64 |
| Race (NIH/OMB)(Participants) | Pembrolizumab Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 74 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Pembrolizumab Arm |
|---|---|
| Spain | 74 |
| Histology(Participants) | Pembrolizumab Arm |
|---|---|
| Adenocarcinoma | 32 |
| Squamous | 33 |
| Large cell carcinoma | 2 |
| Aden squamous | 1 |
| Not otherwise specified / Undifferentiated | 6 |
| Current cancer stage(Participants) | Pembrolizumab Arm |
|---|---|
| IIIB | 6 |
| IV | 68 |
| Previous antineoplastic treatments(participants) | Pembrolizumab Arm |
|---|---|
| Radiotherapy | 24 |
| Surgery | 9 |
| Adjuvant chemotherapy | 6 |
| Concurrent chemoradiotherapy | 5 |
| Neo-adjuvant chemotherapy | 2 |
| No therapy | 28 |
| PD-L1(Participants) | Pembrolizumab Arm |
|---|---|
| 1-19% | 16 |
| 20-49% | 23 |
| ≥50% | 35 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2017 to primary completion in Apr 2023, 75 months.
Results were first posted in Sep 2024, 1 year 4 months after primary completion.
Of 730 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 84. This study's 75 months is above that.
Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pembrolizumab
Carcinoma, Non-Small-Cell Lung →
Spanish Lung Cancer Group