Trial · NCT02220894
Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)
NCT02220894, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2019-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042). Trials, record NCT02220894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02220894
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)
- NCT number
- NCT02220894
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,274 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- pembrolizumab, carboplatin, paclitaxel, pemetrexed
- First posted
- 2014-08-20
- Last updated
- 2026-06-25
- Other registries' IDs
- eudract:2014-001473-14
- Results first posted
- 2019-03-15
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50% | Up to approximately 44 months | OS was determined for participants with a TPS of ≥50% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was OS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The OS for participants with a TPS ≥50% is presented. |
| Primary | Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20% | Up to approximately 44 months | OS was determined for participants with a TPS of ≥20% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was OS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The OS for participants with a TPS ≥20% is presented. |
| Primary | Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1% | Up to approximately 44 months | OS was determined for participants with a TPS of ≥1% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was OS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The OS for participants with a TPS ≥1% is presented. |
| Secondary | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50% | Up to approximately 44 months | PFS was determined for participants with a TPS of ≥50% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was PFS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The PFS for participants with a TPS ≥50% is presented. |
| Secondary | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20% | Up to approximately 44 months | PFS was determined for participants with a TPS of ≥20% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was PFS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The PFS for participants with a TPS ≥20% is presented. |
| Secondary | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥1% | Up to approximately 44 months | PFS was determined for participants with a TPS of ≥1% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was PFS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The PFS for participants with a TPS ≥1% is presented. |
| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50% | Up to approximately 44 months | ORR was determined for participants with a TPS of ≥50%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was ORR in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The percentage of participants who had a TPS ≥50% and who experienced a CR or PR is presented. |
| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20% | Up to approximately 44 months | ORR was determined for participants with a TPS of ≥20%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was ORR in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The percentage of participants who had a TPS ≥20% and who experienced a CR or PR is presented. |
| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥1% | Up to approximately 44 months | ORR was determined for participants with a TPS of ≥1%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was ORR in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The percentage of participants who had a TPS ≥1% and who experienced a CR or PR is presented. |
| Secondary | Number of Participants Who Experienced At Least One Adverse Event (AE) | Up to approximately 38 months | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50% | Up to approximately 44 months | The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20% | Up to approximately 44 months | The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1% | Up to approximately 44 months | The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50% | Up to approximately 44 months | The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20% | Up to approximately 44 months | The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥1% | Up to approximately 44 months | The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50% | Up to approximately 44 months | The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20% | Up to approximately 44 months | The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥1% | Up to approximately 44 months | The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced At Least One Adverse Event (AE) | Up to approximately 38 months | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50% | Pembrolizumab | 20.0 | 95% Confidence Interval 15.9 to 24.2 | Months | |
| Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50% | Chemotherapy (SOC Treatment) | 12.2 | 95% Confidence Interval 10.4 to 14.6 | Months | |
| Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20% | Pembrolizumab | 18.0 | 95% Confidence Interval 15.4 to 21.9 | Months | |
| Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20% | Chemotherapy (SOC Treatment) | 13.0 | 95% Confidence Interval 11.6 to 15.3 | Months | |
| Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1% | Pembrolizumab | 16.4 | 95% Confidence Interval 14.0 to 19.7 | Months | |
| Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1% | Chemotherapy (SOC Treatment) | 12.1 | 95% Confidence Interval 11.3 to 13.3 | Months | |
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50% | Pembrolizumab | 6.5 | 95% Confidence Interval 5.9 to 8.5 | Months | |
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50% | Chemotherapy (SOC Treatment) | 6.4 | 95% Confidence Interval 6.2 to 7.2 | Months | |
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20% | Pembrolizumab | 6.2 | 95% Confidence Interval 5.1 to 7.4 | Months | |
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20% | Chemotherapy (SOC Treatment) | 6.7 | 95% Confidence Interval 6.3 to 8.0 | Months |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab | 637 | |
| Overall Study | STARTED | Chemotherapy (Standard of Care [SOC] Treatment) | 637 | |
| Overall Study | Treated | Pembrolizumab | 636 | |
| Overall Study | Treated | Chemotherapy (Standard of Care [SOC] Treatment) | 615 | |
| Overall Study | COMPLETED | Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Chemotherapy (Standard of Care [SOC] Treatment) | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab | 637 | |
| Overall Study | NOT COMPLETED | Chemotherapy (Standard of Care [SOC] Treatment) | 637 |
Source ClinicalTrials.gov
Adverse events912
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab | 102 | 636 | 124 |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy (SOC Treatment) | 253 | 615 | 332 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 2 | 34 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab | 10 | 636 | 17 |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy (SOC Treatment) | 35 | 615 | 63 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 1 | 34 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab | 6 | 636 | 9 |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy (SOC Treatment) | 85 | 615 | 177 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 0 | 34 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pembrolizumab | 6 | 636 | 7 |
1 to 10 of 912Source ClinicalTrials.gov
See all 912 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab | 528 | 637 |
| Total, all-cause mortality | Chemotherapy (SOC Treatment) | 582 | 637 |
| Total, all-cause mortality | Pembrolizumab Second Course | 18 | 34 |
| Total, other adverse events | Pembrolizumab | 535 | 636 |
| Total, other adverse events | Chemotherapy (SOC Treatment) | 577 | 615 |
| Total, other adverse events | Pembrolizumab Second Course | 21 | 34 |
| Total, serious adverse events | Pembrolizumab | 261 | 636 |
| Total, serious adverse events | Chemotherapy (SOC Treatment) | 193 | 615 |
| Total, serious adverse events | Pembrolizumab Second Course | 8 | 34 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab vs Chemotherapy (SOC Treatment): Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Trial comparisons |
| Pembrolizumab vs Chemotherapy (SOC Treatment): Number of Participants Who Experienced At Least One Adverse Event (AE) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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