Durvalumab after Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer
Scott J. Antonia,A. Villegas,Davey B. Daniel,David Vicente,Shuji Murakami,Rina Hui,Takashi Yokoi,Alberto Chiappori,Ki Hyeong Lee,Maike de Wit,Byoung Chul Cho,M. Bourhaba,Xavier Quantin,Takaaki Tokito,Tarek Mekhail,David Planchard,Young-Chul Kim,Christos S. Karapetis,Sandrine Hiret,Gyula Ostoros,Kaoru Kubota,Jhanelle E. Gray,Luis Paz-Ares,Javier de Castro Carpeño,Catherine Wadsworth,Giovanni Melillo,Haiyi Jiang,Y. Huang,Phillip A. Dennis,Mustafa Ozguroglu,Pacific Investigators +30 more
TLDR
Progression‐free survival was significantly longer with durvalumab than with placebo, and safety was similar between the groups, and the secondary end points also favored durvalsumab.Abstract:
BackgroundMost patients with locally advanced, unresectable, non–small-cell lung cancer (NSCLC) have disease progression despite definitive chemoradiotherapy (chemotherapy plus concurrent radiation therapy). This phase 3 study compared the anti–programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy. MethodsWe randomly assigned patients, in a 2:1 ratio, to receive durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) or placebo every 2 weeks for up to 12 months. The study drug was administered 1 to 42 days after the patients had received chemoradiotherapy. The coprimary end points were progression-free survival (as assessed by means of blinded independent central review) and overall survival (unplanned for the interim analysis). Secondary end points included 12-month and 18-month progression-free survival rates, the objective res...read more
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