Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 28, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT03976323). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1003 participants (ACTUAL). Conditions: Carcinoma, Nonsquamous Non-small-cell Lung. Interventions: BIOLOGICAL: Pembrolizumab; DRUG: Pemetrexed; DRUG: Carboplatin; DRUG: Cisplatin; DRUG: Olaparib. Primary outcome measures: Progression-free Survival (PFS) , Up to ~31 months; Overall Survival (OS) , Up to ~51 months. Brief summary: 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).