PACIFIC-5: a phase III clinical trial of consolidation durvalumab in patients with unresectable stage III NSCLC and no progression after concurrent or sequential chemoradiotherapy

作者：Yi-Long Lung Cancer Wu, Lin Wu, Nan Bi, Timuçin Çil, Hong Ge, Zhengfei Zhu, Chih‐Liang Wang, Wei Zhang, Dongqing Lv, E Mingyan, Jianguo Sun, Yi Pan, Maciej Jerzy Krzakowski, Mustafa Dikilitaş, Mehmet Ali Nahit Sendur, Young‐Chul Kim, Yanjiao Yang, Rui Mao, Biao Zhang, Lühua Wang · 发表于：Journal of Hematology & Oncology · 年份：2025 · DOI：10.1186/s13045-025-01768-1 · 被引用次数：10 · 研究领域：Lung Cancer Treatments and Mutations、Gastric Cancer Management and Outcomes、Colorectal Cancer Treatments and Studies

BACKGROUND: Consolidation durvalumab following no progression on concurrent chemoradiotherapy (cCRT) is standard of care for unresectable stage III non-small-cell lung cancer (NSCLC). However, in clinical practice many patients receive sequential CRT (sCRT). The PACIFIC-5 trial aimed to evaluate the efficacy and safety of consolidation durvalumab for unresectable stage III NSCLC following no progression on cCRT or sCRT. METHODS: This randomised, double-blind, placebo-controlled, phase III trial enrolled patients aged ≥ 18 years with unresectable stage III NSCLC, regardless of PD-L1 expression or sensitising EGFR or ALK aberrations, without disease progression after cCRT or sCRT. Patients were randomised (2:1) to durvalumab 1500 mg or placebo intravenously every 4 weeks (stratified by tumour PD-L1 expression and prior treatment) until disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was progression-free survival (PFS) by blinded independent central review in the modified intention-to-treat population (mITT). Secondary endpoints included overall survival (OS) in the mITT and safety. The safety analysis set include patients who received at least one dose of study treatment. RESULTS: Of 407 patients randomised to receive durvalumab (n = 272) or placebo (n = 135), 405 received at least one dose of durvalumab (n = 271) or placebo (n = 134). The mITT comprised 381 patients randomised to durvalumab (n = 252) or placebo (n = 129). Durvalumab show...