A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Squamous Cell, Non-small-cell Lung

In brief

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS). As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.

Key facts

Study ID: NCT03976362
Run by: Merck Sharp & Dohme LLC
People needed: 851
Starts: 2019-06-28
Expected to finish: 2026-01-30
Last updated by the study team: 2026-02-25

Who can join

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

You may qualify if…

Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
Have Stage IV squamous NSCLC.
Have measurable disease based on RECIST 1.1.
Have not received prior systemic treatment for their advanced/metastatic NSCLC.
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 receive study intervention(s). 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 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 a life expectancy of at least 3 months.
Has 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 during the treatment period and for 180 days afterwards.

You may not qualify if…

Has non-squamous 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 metastases and/or carcinomatous meningitis.
Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib.
Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
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.

Where it is running

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
H. Lee Moffitt Cancer Center and Research Institute ( Site 0024) — Tampa, Florida, United States
Columbus Regional Research Institute ( Site 0099) — Columbus, Georgia, United States
Mount Sinai Hospital Medical Center ( Site 0035) — Chicago, Illinois, United States
Oncology of Northshore ( Site 0036) — Rolling Meadows, Illinois, United States
Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039) — Merrillville, Indiana, United States
MedStar Franklin Square Medical Center ( Site 0044) — Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute ( Site 0046) — Detroit, Michigan, United States
Hattiesburg Clinic ( Site 0051) — Hattiesburg, Mississippi, United States
Frontier Oncology ( Site 0052) — Billings, Montana, United States
Bozeman Health Deaconness Cancer Center ( Site 0053) — Bozeman, Montana, United States
Waverly Hematology Oncology ( Site 0054) — Cary, North Carolina, United States
Thompson Cancer Survival Center ( Site 2812) — Knoxville, Tennessee, United States
Renovatio Clinical ( Site 0074) — The Woodlands, Texas, United States
Cancer Care Northwest ( Site 0083) — Spokane Valley, Washington, United States
Hospital Italiano Regional del Sur ( Site 0509) — Bahía Blanca, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516) — Mar del Plata, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires ( Site 0500) — Buenos Aires, Buenos Aires F.D., Argentina
Instituto Medico Rio Cuarto ( Site 0501) — Río Cuarto, Córdoba Province, Argentina
Sanatorio Parque ( Site 0515) — Rosario, Santa Fe Province, Argentina
Centro Oncológico de Rosario ( Site 0507) — Rosario, Santa Fe Province, Argentina
Centro Medico San Roque ( Site 0506) — San Miguel de Tucumán, Tucumán Province, Argentina
Alabama Oncology Bruno Cancer Center ( Site 0001) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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