OncRef

Clinical Trial: NCT03425643

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-07-29

Study Overview

Brief Summary

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).

Official Title

A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

Conditions

Non-small Cell Lung Cancer

Intervention / Treatment

  • Biological: Pembrolizumab
  • Drug: Placebo
  • Drug: Cisplatin
  • Drug: Gemcitabine
  • Drug: Pemetrexed

Other Study ID Numbers

  • 3475-671
  • MK-3475-671
  • 183970
  • 2023-504820-24-00
  • U1111-1289-8426
  • 2017-001832-21
  • 2017
  • 2023

Start Date (Actual)

2018-04-24

Primary Completion Date (Actual)

2023-07-10

Study Completion Date (Estimated)

2026-10-15

Enrollment (Actual)

797

Study Type

Interventional

Phase

Phase 3