Trial · NCT02504372

Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091)

NCT02504372, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2024-02-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091). Trials, record NCT02504372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02504372

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091)
NCT number: NCT02504372
Status: Completed
Phases: Phase 3
Enrollment: 1,177 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Non-small Cell Lung Cancer
Interventions: Pembrolizumab, Placebo
First posted: 2015-07-21
Last updated: 2026-03-17
Other registries' IDs: eudract:2015-000575-27
Results first posted: 2024-02-15

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease-Free Survival (DFS)	Up to approximately 84 months	DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.
Primary	DFS in Programmed Death Ligand-1 (PDL-1) Strong Positive Participants With Tumor Proportion Score (TPS) ≥50%	Up to approximately 84 months	DFS in PDL-1 strong positive participants with TPS ≥50% was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.
Secondary	DFS in PDL-1 Strong Positive Participants With TPS ≥1%	Up to approximately 84 months	DFS in PDL-1 strong positive participants with TPS ≥1% was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.
Secondary	Overall Survival (OS)	Up to approximately 132 months	OS was defined as the time from randomization to the date of death.
Secondary	OS in PDL-1 Strong Positive Participants With TPS ≥50%	Up to approximately 132 months	OS in PDL-1 Strong Positive Participants with TPS ≥50% was defined as the time from randomization to the date of death.
Secondary	OS in PDL-1 Strong Positive Participants With TPS ≥1%	Up to approximately 132 months	OS in PDL-1 Strong Positive Participants with TPS ≥1% was defined as the time from randomization to the date of death.
Secondary	Lung Cancer Specific Survival (LCSS)	Up to approximately 132 months	LCSS was defined as the time from randomization to the date of death (due to lung cancer specifically).
Secondary	Number of Participants Who Experienced an Adverse Event (AE)	Up to approximately 22 months	An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. The number of participants who experienced an AE were reported.
Secondary	Number of Participants Who Discontinued Study Treatment Due to an AE	Up to approximately 19 months	An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. The number of participants who discontinued study treatment due to an AE were reported.
Other	DFS at 68 Months	Up to approximately 68 months	DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-Free Survival (DFS)	Up to approximately 84 months	All randomized participants. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	Months	MEDIAN
PRIMARY	DFS in Programmed Death Ligand-1 (PDL-1) Strong Positive Participants With Tumor Proportion Score (TPS) ≥50%	Up to approximately 84 months	All randomized PDL-1 strong positive participants with TPS ≥50%. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	Months	MEDIAN
SECONDARY	DFS in PDL-1 Strong Positive Participants With TPS ≥1%	Up to approximately 84 months	All randomized PDL-1 strong positive participants with TPS ≥1%. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	Months	MEDIAN
SECONDARY	Overall Survival (OS)	Up to approximately 132 months
SECONDARY	OS in PDL-1 Strong Positive Participants With TPS ≥50%	Up to approximately 132 months
SECONDARY	OS in PDL-1 Strong Positive Participants With TPS ≥1%	Up to approximately 132 months
SECONDARY	Lung Cancer Specific Survival (LCSS)	Up to approximately 132 months
SECONDARY	Number of Participants Who Experienced an Adverse Event (AE)	Up to approximately 22 months	All randomized participants who received at least one dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Discontinued Study Treatment Due to an AE	Up to approximately 19 months		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	DFS at 68 Months	Up to approximately 68 months	All randomized participants. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	Months	MEDIAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Disease-Free Survival (DFS)	Pembrolizumab	53.8	95% Confidence Interval 46.2 to 67.0	Months
Disease-Free Survival (DFS)	Placebo	43.0	95% Confidence Interval 35.0 to 51.6	Months
DFS in Programmed Death Ligand-1 (PDL-1) Strong Positive Participants With Tumor Proportion Score (TPS) ≥50%	Pembrolizumab	67.0	95% Confidence Interval 47.8 to NA	Months
DFS in Programmed Death Ligand-1 (PDL-1) Strong Positive Participants With Tumor Proportion Score (TPS) ≥50%	Placebo	47.6	95% Confidence Interval 36.4 to NA	Months
DFS in PDL-1 Strong Positive Participants With TPS ≥1%	Pembrolizumab	58.7	95% Confidence Interval 46.2 to 76.7	Months
DFS in PDL-1 Strong Positive Participants With TPS ≥1%	Placebo	42.8	95% Confidence Interval 35.0 to 57.8	Months
Number of Participants Who Experienced an Adverse Event (AE)	Pembrolizumab	556		Participants
Number of Participants Who Experienced an Adverse Event (AE)	Placebo	529		Participants
Number of Participants Who Discontinued Study Treatment Due to an AE	Pembrolizumab	116		Participants
Number of Participants Who Discontinued Study Treatment Due to an AE	Placebo	34		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pembrolizumab	590
Overall Study	STARTED	Placebo	587
Overall Study	Treated	Pembrolizumab	580
Overall Study	Treated	Placebo	581
Overall Study	COMPLETED	Pembrolizumab	0
Overall Study	COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Pembrolizumab	590
Overall Study	NOT COMPLETED	Placebo	587

Source ClinicalTrials.gov

Adverse events456

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	Hyperthyroidism	Endocrine disorders	Pembrolizumab	62	580	65
other	Hyperthyroidism	Endocrine disorders	Placebo	17	581	18
other	Hypothyroidism	Endocrine disorders	Pembrolizumab	120	580	148
other	Hypothyroidism	Endocrine disorders	Placebo	27	581	29
other	Constipation	Gastrointestinal disorders	Pembrolizumab	35	580	38
other	Constipation	Gastrointestinal disorders	Placebo	41	581	53
other	Diarrhoea	Gastrointestinal disorders	Pembrolizumab	104	580	179
other	Diarrhoea	Gastrointestinal disorders	Placebo	82	581	160
other	Nausea	Gastrointestinal disorders	Pembrolizumab	52	580	64
other	Nausea	Gastrointestinal disorders	Placebo	37	581	48

1 to 10 of 456Source ClinicalTrials.gov

See all 456 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pembrolizumab	136	590
Total, all-cause mortality	Placebo	154	587
Total, other adverse events	Pembrolizumab	510	580
Total, other adverse events	Placebo	458	581
Total, serious adverse events	Pembrolizumab	142	580
Total, serious adverse events	Placebo	90	581

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36108662	DERIVED

Source PubMed

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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pembrolizumab vs Placebo: Number of Participants Who Experienced an Adverse Event (AE)	Trial comparisons
Pembrolizumab vs Placebo: deaths from any cause	Trial comparisons
Pembrolizumab vs Placebo: Number of Participants Who Discontinued Study Treatment Due to an AE	Trial comparisons
Pembrolizumab vs Placebo: serious adverse events	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

GET https://conductscience.org/api/trials/v1/NCT02504372

GET https://conductscience.org/api/trials/v1/NCT02504372/events?page=2

API reference For AI assistants