OncRef

Clinical Trial: NCT03976362

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)

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-02-25

Study Overview

Brief Summary

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.

Official Title

A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

Conditions

Carcinoma, Squamous Cell, Non-small-cell Lung

Intervention / Treatment

  • Biological: Pembrolizumab
  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Drug: Nab-paclitaxel
  • Drug: Olaparib
  • Drug: Placebo

Other Study ID Numbers

  • 7339-008
  • MK-7339-008
  • KEYLYNK-008
  • 194894
  • 2023-508449-41-00
  • U1111-1298-1950
  • 2018-004721-88
  • 2018
  • 2023

Start Date (Actual)

2019-06-28

Primary Completion Date (Actual)

2023-09-21

Study Completion Date (Actual)

2026-01-30

Enrollment (Actual)

851

Study Type

Interventional

Phase

Phase 3