OncRef

Clinical Trial: NCT03976323

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)

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-09-28

Study Overview

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).

Official Title

A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC)

Conditions

Carcinoma, Nonsquamous Non-small-cell Lung

Intervention / Treatment

  • Biological: Pembrolizumab
  • Drug: Pemetrexed
  • Drug: Carboplatin
  • Drug: Cisplatin
  • Drug: Olaparib

Other Study ID Numbers

  • 7339-006
  • MK-7339-006
  • KEYLYNK-006
  • 194895
  • 2023-509774-40-00
  • U1111-1300-7107
  • 2018-004720-11
  • 2018
  • 2023

Start Date (Actual)

2019-06-28

Primary Completion Date (Actual)

2024-02-07

Study Completion Date (Actual)

2026-01-30

Enrollment (Actual)

1003

Study Type

Interventional

Phase

Phase 3