Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)
CompletedPhase 3Results postedLast updated 25 February 2026
What this trial tests
Phase 3 trial testing Pembrolizumab in Carcinoma, Nonsquamous Non-small-cell Lung in 1,003 participants. Completed in 29 January 2026.
18 and older, any sex, with Carcinoma, Nonsquamous Non-small-cell Lung. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS)Primary· Up to ~31 months
PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS was analyzed by the non-parametric Kaplan-Meier (K-M) method. The proto
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
7.1
5.6 – 8.7
Pembrolizumab + Pemetrexed (Maintenance Phase)
8.3
6.9 – 11.5
Overall Survival (OS)Primary· Up to ~51 months
OS was defined as the time from randomization to death due to any cause. OS was analyzed by the non-parametric K-M method. Participants without documented death at the time of analyses were censored at the date of last known to be alive. The protocol specified final analysis of OS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
20.7
18.0 – 24.8
Pembrolizumab + Pemetrexed (Maintenance Phase)
23.0
19.0 – 26.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale ScoreSecondary· Baseline and Week 24
EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
-5.34
-7.78 – -2.90
Pembrolizumab + Pemetrexed (Maintenance Phase)
-3.44
-5.90 – -0.98
Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale ScoreSecondary· Up to ~24 months
EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participant responses to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD is defined as the time fro
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
19.81
15.97 – NA
Pembrolizumab + Pemetrexed (Maintenance Phase)
17.28
9.46 – NA
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale ScoreSecondary· Baseline and Week 24
EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding cough (Item 1): "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or cond
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
-1.98
-4.90 – 0.94
Pembrolizumab + Pemetrexed (Maintenance Phase)
-1.82
-4.77 – 1.12
TTD in EORTC QLQ-LC13 Cough (Item 1) Scale ScoreSecondary· Up to ~24 months
EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding cough (Item 1): "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 1). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
NA
NA – NA
Pembrolizumab + Pemetrexed (Maintenance Phase)
NA
NA – NA
Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale ScoreSecondary· Baseline and Week 24
EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding chest pain (Item 10): "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
-0.82
-3.25 – 1.61
Pembrolizumab + Pemetrexed (Maintenance Phase)
-0.47
-2.92 – 1.98
TTD in EORTC QLQ-LC13 Chest Pain (Item 10) Scale ScoreSecondary· Up to ~24 months
EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding chest pain (Item 10): "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in chest pain (Item 10). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
NA
NA – NA
Pembrolizumab + Pemetrexed (Maintenance Phase)
NA
NA – NA
Change From Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale ScoreSecondary· Baseline and Week 24
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question regarding dyspnea (Item 8): "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score is presented. The protocol specified final analysis for the first pembrolizumab course in Maintenance Phase is reported. Per protocol, analysis for this outcome meas
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
-0.16
-3.07 – 2.76
Pembrolizumab + Pemetrexed (Maintenance Phase)
1.35
-1.60 – 4.31
TTD in EORTC QLQ-C30 Dyspnea (Item 8) Scale ScoreSecondary· Up to ~24 months
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question regarding dyspnea (Item 8): "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in dyspnea (Item 8). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outco
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
NA
NA – NA
Pembrolizumab + Pemetrexed (Maintenance Phase)
NA
NA – NA
Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale ScoreSecondary· Baseline and Week 24
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 is computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score is presented. The protocol spe
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
-2.79
-4.92 – -0.65
Pembrolizumab + Pemetrexed (Maintenance Phase)
-2.78
-4.93 – -0.62
TTD in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale ScoreSecondary· Up to ~24 months
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 is computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physica
Group
Value
95% CI
Pembrolizumab + Olaparib (Maintenance Phase)
20.96
13.34 – NA
Pembrolizumab + Pemetrexed (Maintenance Phase)
NA
17.28 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to ~51 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
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NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527
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NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M
· Phase 3
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NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 25 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03976323.