OncRef

Clinical Trial: NCT02504372

Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091)

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-03-17

Study Overview

Brief Summary

In this study, participants with Stage IB/II-IIIA non-small cell lung cancer (NSCLC) who have undergone surgical resection (lobectomy or pneumonectomy) with or without adjuvant chemotherapy will be treated with pembrolizumab or placebo. The primary study hypothesis is that pembrolizumab will provide improved disease-free survival (DFS) versus placebo.

Official Title

A Randomized, Phase 3 Trial With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo for Patients With Early Stage NSCLC After Resection and Completion of Standard Adjuvant Therapy (PEARLS)

Conditions

Non-small Cell Lung Cancer

Intervention / Treatment

  • Biological: Pembrolizumab
  • Other: Placebo

Other Study ID Numbers

  • 3475-091
  • EORTC-1416-LCG
  • 163457
  • MK-3475-091
  • KEYNOTE-091
  • 2023-509137-39-00
  • U1111-1309-6051
  • 2015-000575-27
  • 2015
  • 2023

Start Date (Actual)

2015-11-06

Primary Completion Date (Actual)

2023-01-24

Study Completion Date (Actual)

2026-01-21

Enrollment (Actual)

1177

Study Type

Interventional

Phase

Phase 3