CompletedPhase 3NCT03976323

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)

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).

Checked against the public recordLast updated Jul 6, 2026 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations178
SponsorMerck Sharp & Dohme LLC
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Merck Sharp & Dohme LLC
Interventions being studied
Biological: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin; Drug: Olaparib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC. 2. Have stage IV nonsquamous NSCLC. 3. Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated. 4. Have measurable disease based on RECIST 1.1. 5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can start the induction phase. Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time. 6. Have a life expectancy of at least 3 months. 7. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention. 8. Have not received prior systemic treatment for their advanced/metastatic NSCLC. 9. Have adequate organ function. 10. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards. 11. Male participants must refrain from donating sperm, and female participants must refrain from donating eggs to others or freeze/store for her own use during the treatment period and for 180 days afterwards. Exclusion Criteria: 1. Has predominantly squamous cell histology NSCLC. 2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment. 3. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 4. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. 5. Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib. 6. Has an active autoimmune disease that has required systemic treatment in past 2 years. 7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. 8. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection. 9. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment. 10. Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor. 11. Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137). 12. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML. 13. Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. 14. Has completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Alabama Oncology Bruno Cancer Center ( Site 0001)Birmingham, Alabama
  • Northwest Alabama Cancer Center, PC ( Site 0002)Muscle Shoals, Alabama
  • Disney Family Cancer Center ( Site 0005)Burbank, California
  • Boca Raton Regional Hospital ( Site 0018)Boca Raton, Florida
  • Mid-Florida Cancer Centers ( Site 0022)Orange City, Florida
  • Moffitt Cancer Center ( Site 0024)Tampa, Florida
  • Columbus Regional Research Institute ( Site 0098)Columbus, Georgia
  • Mount Sinai Hospital Medical Center ( Site 0032)Chicago, Illinois
  • Oncology of Northshore ( Site 0033)Rolling Meadows, Illinois
  • Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)Merrillville, Indiana
  • Medstar Good Samaritan Hospital ( Site 0040)Baltimore, Maryland
  • Barbara Ann Karmanos Cancer Institute ( Site 0041)Detroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2026. Always confirm current availability with the study team.

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