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)

Completed · Phase 3

Conditions studied: Carcinoma, Nonsquamous Non-small-cell Lung

In brief

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).

Key facts

Study ID

NCT03976323

Run by

Merck Sharp & Dohme LLC

People needed

1003

Starts

2019-06-28

Expected to finish

2026-01-29

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
• Have stage IV nonsquamous NSCLC.
• Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
• Have measurable disease based on RECIST 1.1.
• 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.
• Have a life expectancy of at least 3 months.
• 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.
• Have not received prior systemic treatment for their advanced/metastatic NSCLC.
• Have adequate organ function.
• 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.
• 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.

You may not qualify if…

• Has predominantly squamous cell histology NSCLC.
• Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
• Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
• Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
• Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
• 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).
• Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
• Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
• Has completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Where it is running

• Northwest Alabama Cancer Center, PC ( Site 0002) — Muscle Shoals, Alabama, United States
• Disney Family Cancer Center ( Site 0005) — Burbank, California, United States
• Boca Raton Regional Hospital ( Site 0018) — Boca Raton, Florida, United States
• Mid-Florida Cancer Centers ( Site 0022) — Orange City, Florida, United States
• Moffitt Cancer Center ( Site 0024) — Tampa, Florida, United States
• Columbus Regional Research Institute ( Site 0098) — Columbus, Georgia, United States
• Mount Sinai Hospital Medical Center ( Site 0032) — Chicago, Illinois, United States
• Oncology of Northshore ( Site 0033) — Rolling Meadows, Illinois, United States
• Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036) — Merrillville, Indiana, United States
• Medstar Good Samaritan Hospital ( Site 0040) — Baltimore, Maryland, United States
• Barbara Ann Karmanos Cancer Institute ( Site 0041) — Detroit, Michigan, United States
• Hattiesburg Clinic ( Site 0045) — Hattiesburg, Mississippi, United States
• Frontier Oncology ( Site 0080) — Billings, Montana, United States
• Bozeman Health Deaconness Cancer Center ( Site 0046) — Bozeman, Montana, United States
• Waverly Hematology Oncology ( Site 0081) — Cary, North Carolina, United States
• Thompson Cancer Survival Center ( Site 2812) — Knoxville, Tennessee, United States
• University of Tennessee Medical Center Knoxville ( Site 0060) — Knoxville, Tennessee, United States
• Renovatio Clinical ( Site 0062) — The Woodlands, Texas, United States
• Cancer Care Northwest ( Site 0071) — Spokane Valley, Washington, United States
• Hospital Italiano Regional del Sur ( Site 0509) — Bahía Blanca, Buenos Aires, Argentina
• Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0511) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Hospital Britanico de Buenos Aires ( Site 0500) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Instituto Medico Rio Cuarto ( Site 0501) — Río Cuarto, Córdoba Province, Argentina
• Centro Oncológico de Rosario ( Site 0507) — Rosario, Santa Fe Province, Argentina
• Alabama Oncology Bruno Cancer Center ( Site 0001) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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