NCT03425643

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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)

Phase

Phase 3

Status

Active not recruiting

Conditions

Non-small Cell Lung Cancer

Interventions

Pembrolizumab; Placebo; Cisplatin; Gemcitabine; Pemetrexed

Arms

• NAC + Neoadjuvant/Adjuvant Pembrolizumab · Experimental
• NAC + Neoadjuvant/Adjuvant Placebo · Placebo comparator

Enrollment

797

Primary outcomes

• Event Free Survival (EFS)
• Overall Survival (OS)

Sponsor

Merck Sharp & Dohme LLC

Start

Apr 24, 2018

Primary completion

Jul 10, 2023

Results posted

Yes

Registry record

NCT03425643 · updated Jul 29, 2026

• Spicer JD, Garassino MC, Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Arunachalam A, Keller SM, Samkari A, Gao S; KEYNOTE-671 Investigators. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Sep 28;404(10459):1240-1252. doi: 10.1016/S0140-6736(24)01756-2. Epub 2024 Sep 14. PubMed 39288781
• Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Gao S, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Keller SM, Samkari A, Spicer JD; KEYNOTE-671 Investigators. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):491-503. doi: 10.1056/NEJMoa2302983. Epub 2023 Jun 3. PubMed 37272513
• Tsuboi M, Saji H, Okada M, Ikeda N, Takamochi K, Sugio K, Horio Y, Tanaka F, Nishio W, Muto S, Horinouchi H, Wakelee H, Han S, Mori T, Keller SM, Kato T. Perioperative Pembrolizumab in Japanese Participants With Early-Stage NSCLC: Subgroup Analysis From KEYNOTE-671. JTO Clin Res Rep. 2026 May 2;7(10):101009. doi: 10.1016/j.jtocrr.2026.101009. eCollection 2026 Oct. PubMed 42774586
• Wakelee H, Spicer JD, Gao S, Liberman M, Tsuboi M, Kato T, Chen KN, Dooms C, Majem M, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Halmos B, Jones DR, Chaft JE, Reck M, Jensen E, Keller SM, Samkari A, Garassino MC. Five-Year Outcomes of Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer From the Randomized KEYNOTE-671 Study. Ann Oncol. 2026 Aug 21:S0923-7534(26)01462-6. doi: 10.1016/j.annonc.2026.08.005. Online ahead of print. PubMed 42628840
• Tsuboi M, Wakelee H, Garassino MC, Gao S, Luft A, Chen KN, Spicer JD, Zhu Y, Saji H, Okada M, Vanakesa T, Chen H, Zhao G, Ikeda N, Jones DR, Weksler B, Huang CS, Jensen E, Keller SM, Samkari A, Liberman M. A Subgroup Analysis of Perioperative Pembrolizumab in Clinical Stage II Non-Small-Cell Lung Cancer from the Randomized KEYNOTE-671 Study. Eur J Cardiothorac Surg. 2026 Mar 10;68(3):ezag028. doi: 10.1093/ejcts/ezag028. PubMed 41875364
• Aredo JV, Wakelee HA. Top advances of the year: Perioperative therapy for lung cancer. Cancer. 2024 Sep 1;130(17):2897-2903. doi: 10.1002/cncr.35357. Epub 2024 May 8. PubMed 38717993
• Romero Roman A, Campo-Canaveral de la Cruz JL, Macia I, Escobar Campuzano I, Figueroa Almanzar S, Delgado Roel M, Galvez Munoz C, Garcia Fontan EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martinez Tellez E, Partida Gonzalez C, Jimenez Lopez MF, Jimenez Maestre U, Mongil Poce R, Sanchez Lorente D, Alvarez Kindelan A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007. PubMed 33661301