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
Abstract
Summary Background: At the first interim analysis of the KEYNOTE-671 trial, adding perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved event-free survival in participants with early-stage non-small-cell lung cancer (NSCLC). We report overall survival and health-related quality of life outcomes from the second interim analysis. Methods: KEYNOTE-671 was a global phase 3 trial done at 189 medical centres. Eligible participants with resectable stage II, IIIA, or IIIB (N2) NSCLC were randomised (1:1) to neoadjuvant cisplatin-based chemotherapy plus pembrolizumab (200 mg) or placebo administered intravenously every 3 weeks for 4 cycles and adjuvant pembrolizumab (200 mg) or placebo administered intravenously every 3 weeks for 13 cycles. Randomisation was done centrally using an interactive response technology system and was stratified by disease stage, PD-L1 expression, histology, and geographic region in blocks of four. Participants, investigators, and sponsor personnel were masked to treatment assignments; local pharmacists were unmasked to support treatment preparation. Overall survival evaluated in the intention-to-treat population was a primary endpoint. This study is registered at ClinicalTrials.gov, NCT03425643. Findings: Between April 2018 and December 2021, 1364 patients were screened for eligibility, 797 of whom were randomised to the pembrolizumab group (n=397) or the placebo group (n=400). Median study follow-up at the second interim analysis…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 400 participants or records.
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