Science and Research

Phase III, Randomized, Placebo Controlled Trial of Platinum Doublet Chemotherapy +/- Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants with Resectable Stage II or IIIA Non-Small Cell Lung Cancer (NSCLC) (Keynote-671)

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).

Study details
Study-ID: NCT03425643, 2017-001832-21
Study-ID: NCT03425643, 2017-001832-21
DZL Disease Area: LC
DZL Disease Area: LC
Study Type: Interventional
Study Type: Interventional
DZL Role: DZL recruiting center
DZL Role: DZL recruiting center
Funding: Externally - industry
Funding: Externally - industry
DZL Participating Sites: ARCN
DZL Participating Sites: ARCN
Start Date: 24.04.2018
Completion Date: 29.06.2026
Status: Active / not recruiting
Status: Active / not recruiting
DZL recruiting center
Link to Study


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