Durvalumab Alone or Combined With Novel Agents for Unresectable Stage III Non–Small Cell Lung Cancer

作者：Charu Aggarwal, Alex Martínez‐Martí, Margarita Majem, Fabrice Barlési, Enric Carcereny, Quincy Chu, I. Monnet, Alfredo Sánchez-Hernández, Shaker R. Dakhil, D. Ross Camidge, Marine Pillet, Miranda Brown, Christos Paliompeis, Adam Dowson, Zachary A. Cooper, Rakesh Kumar, Roy S. Herbst · 发表于：JAMA Network Open · 年份：2025 · DOI：10.1001/jamanetworkopen.2025.18440 · 被引用次数：25 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment

Importance: The PACIFIC trial established durvalumab as the standard-of-care therapy for unresectable, stage III non-small cell lung cancer (NSCLC) without progression following concurrent chemoradiotherapy (cCRT). Novel immunotherapy combinations involving the anti-CD73 monoclonal antibody oleclumab or the anti-NKG2A monoclonal antibody monalizumab have the potential to build on the durvalumab standard of care. Objective: To report updated results from the phase 2 COAST trial of consolidation durvalumab alone or combined with oleclumab or monalizumab in patients with unresectable, stage III NSCLC and no progression following cCRT. Design, Setting, and Participants: COAST was an open-label, phase 2, multidrug platform randomized clinical trial conducted across 73 sites globally. Patients with an Eastern Cooperative Oncology Group Performance Status of 0 or 1 and no progression following definitive platinum-based cCRT were enrolled between January 2019 and July 2020. The data cutoff for this final analysis was July 18, 2023. Data were analyzed from September 2023 to March 2024. Intervention: Patients were randomized 1:1:1, stratified by histologic type within 42 days after cCRT, to durvalumab alone or durvalumab combined with oleclumab or monalizumab for up to 12 months. Main Outcomes and Measures: The primary end point was investigator-assessed confirmed objective response rate (ORR). Key secondary end points included investigator-assessed progression-free survival (PFS), ove...