Trial reportEuropean journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery2026
A Subgroup Analysis of Perioperative Pembrolizumab in Clinical Stage II Non-Small-Cell Lung Cancer from the Randomized KEYNOTE-671 Study.
Trial report in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03425643 (A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab), which is not on this map. Cited by 2 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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)
Who cites it
2 citing papers in PubMed.
- Is Neoadjuvant Chemoimmunotherapy Safe in Surgically High-Risk Lung Cancer Patients? A Single-Centre IPTW Analysis.Journal of clinical medicine · 2026Article
- Review
Corrections and comments
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Authors and funding
21 authors.
Funding
Abstract
objectivesPerioperative pembrolizumab plus neoadjuvant chemotherapy significantly improved outcomes versus neoadjuvant chemotherapy alone in early-stage, resectable, non-small-cell lung cancer (NSCLC) in the phase 3 KEYNOTE-671 study. We report outcomes in participants with baseline clinical stage II disease.
methodsParticipants with untreated, resectable, stage II-IIIB (N2) NSCLC were randomized 1:1 to receive pembrolizumab 200 mg or placebo every 3 weeks plus chemotherapy for 4 cycles, followed by surgery and adjuvant pembrolizumab or placebo for 13 cycles (∼9 months). Exploratory analyses were performed in participants with clinical stage II disease.
resultsOf 797 randomized participants, 239 had stage II disease (pembrolizumab plus chemotherapy, n = 118; chemotherapy only, n = 121). Median study follow-up at data cutoff (August 19, 2024) was 49.9 (range, 32.2-75.3) months. Among participants who underwent surgery, 94/99 (94.9%) had R0 resections in the pembrolizumab arm and 89/103 (86.4%) in the neoadjuvant chemotherapy only arm. Event-free survival (hazard ratio [HR], 0.50; 95% CI, 0.34-0.74), overall survival (HR, 0.69; 95% CI, 0.43-1.11), major pathological response (difference, 25.7%; 95% CI, 15.3-35.9), and pathological complete response (difference, 21.3%; 95% CI, 13.2-30.2) were improved in the pembrolizumab arm. Grade 3-4 treatment-related adverse events (AEs) occurred in 50.0% of participants treated with pembrolizumab plus chemotherapy and 40.5% with chemotherapy; no treatment-related AEs led to death.
conclusionsIn participants with stage II NSCLC, perioperative pembrolizumab improved efficacy outcomes with manageable safety versus neoadjuvant chemotherapy alone, consistent with the overall KEYNOTE-671 population. These results support the use of this regimen in patients with stage II disease.
trial registrationClinicalTrials.gov, NCT03425643, registered/first posted on February 7, 2018 (https://www.clinicaltrials.gov/study/NCT03425643).
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