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
    Recruiting
  • End date
    Jun 29, 2026
  • participants needed
    786
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 5 December 2021
pemetrexed
gemcitabine
pembrolizumab
cancer chemotherapy
solid tumour
mk-3475
platinum doublet
lung carcinoma

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 blinded central pathologist or by imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by blinded independent central review (BICR); and 2) overall survival (OS).

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment cisplatin, Placebo, Gemcitabine, Pembrolizumab, Pemetrexed
Clinical Study IdentifierNCT03425643
SponsorMerck Sharp & Dohme Corp.
Last Modified on5 December 2021

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