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)
NCT03976323 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1003
Last updated 2026-02-25
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).
Conditions
- Carcinoma, Nonsquamous Non-small-cell Lung
Interventions
- BIOLOGICAL
-
IV infusion
- DRUG
-
Pemetrexed
IV infusion
- DRUG
-
IV infusion
- DRUG
-
IV infusion
- DRUG
-
Oral Tablet
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-28
- Primary Completion
- 2024-02-07
- Completion
- 2026-01-29
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Brazil
- Canada
- Colombia
- France
- Germany
- Japan
- New Zealand
- Poland
- Romania
- Russia
- South Korea
- Spain
- Taiwan
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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