BENITIONSClinical Trial Intelligence

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)

Phase 3 Completed NCT03976323

ConditionCarcinoma, Nonsquamous Non-small-cell Lung
PhasePhase 3
SponsorMerck Sharp & Dohme LLC
StatusCompleted
Enrollment1,003 participants
InterventionsPembrolizumab, Pemetrexed, Carboplatin, Cisplatin, Olaparib
Start dateJun 28, 2019
Completion dateFeb 7, 2024
Results postedFeb 6, 2025

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).

Progression-free Survival (PFS)

Up to ~31 months · Months

Pembrolizumab + Olaparib (Maintenance Phase)7.1 Months
Pembrolizumab + Pemetrexed (Maintenance Phase)8.3 Months
p-value0.8721
Hazard Ratio (HR)1.12 (95% CI 0.92–1.36)

Overall Survival (OS)

Up to ~51 months · Months

Pembrolizumab + Olaparib (Maintenance Phase)20.7 Months
Pembrolizumab + Pemetrexed (Maintenance Phase)23.0 Months
p-value0.6649
Hazard Ratio (HR)1.04 (95% CI 0.87–1.25)

Open in BENITIONS View on ClinicalTrials.gov

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