Caicun Zhou, Ziping Wang, Meili Sun, Lejie Cao, Zhiyong Ma, Rong Wu, Yan Yu, Wenxiu Yao, Si Sun, Jianhua Chen, Wu Zhuang, Jiuwei Cui, Xueqin Chen, You Lu, Hong Shen, Chunhong Hu, Jiwei Liu, Yunpeng Liu, Mengzhao Wang, Xingya Li, Ping Sun, Yongqian Shu, Jianying Zhou, Jingzhang Li, Kangsheng Gu, Changli Wang, Hui Zhao, Yiping Zhang, Chunling Liu, Jingru Wang, Rumei Chen, Mengmeng Qin, Hao Wang, Jason Yang
The randomized, double-blinded, multi-center, phase III GEMSTONE-302 ( NCT03789604 ) study evaluated the efficacy and safety of sugemalimab versus placebo in combination with chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (NSCLC). In this study, 479 treatment-naive patients with stage IV squamous or non-squamous NSCLC without known EGFR sensitizing mutations, ALK, ROS1 or RET fusions were randomized (2:1) to receive 1,200 mg of sugemalimab (n = 320) or placebo (n = 159) every 3 weeks in combination with platinum-based chemotherapy for up to four cycles, followed by maintenance therapy with sugemalimab or placebo for squamous NSCLC and sugemalimab or placebo plus pemetrexed for non-squamous NSCLC...
June 2023: Nature Cancer