A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer

医学 安慰剂 内科学 危险系数 卡铂 依托泊苷 肺癌 胃肠病学 不利影响 临床终点 外科 随机对照试验 化疗 病理 置信区间 替代医学 顺铂
作者
Zhiwei Chen,Jianhua Chen,Dingzhi Huang,Wei Zhang,Lin Wu,Tienan Yi,Qiming Wang,Han Liang,Liping Tan,Yinyin Li,Zhihong Zhang,Na Li,Jie Li,Tongmei Zhang,Ying Hu,Hongmei Sun,Youhua Wu,Zhiyong He,Runxiang Yang,Cheng Peng,Xingya Li,Jianhua Shi,Guohua Yu,Daiyuan Ma,Benjamin Xiaoyi Li,Xiangrong Dai,Michael Wong,Yujie Li,Xiaohui Yu,Shun Lü,Benjamin Xiaoyi Li,Xiangrong Dai,Michael Wong,Yujie Li,Xiaohui Yu
出处
期刊:Signal Transduction and Targeted Therapy [Springer Nature]
卷期号:10 (1)
标识
DOI:10.1038/s41392-024-02115-5
摘要

Abstract This is a randomized, double-blind, placebo-controlled phase 3 clinical trial (ClinicalTrials.gov, NCT04878016) conducted in 54 hospitals in China. Adults who were histologically diagnosed and never treated for extensive-stage small cell lung cancer (ES-SCLC) were enrolled. Eligible Patients were randomly assigned (1:1) to receive four cycles (21 days as one cycle) of intravenous carboplatin (area under the curve of 5 mg/mL per min, day 1 of each cycle) and etoposide (100 mg/m² of body-surface area, on days 1–3 of each cycle) with either socazolimab (5 mg/kg, day 1 of each cycle) or matching placebo, following maintenance therapy with socazolimab or placebo. From July 15, 2021, to May 12, 2022, 498 eligible patients were randomly assigned to receive socazolimab (250 patients) or placebo (248 patients) combined with chemotherapy. As of October 13, 2023, patients treated with socazolimab presented significant overall survival (OS) benefit (13.90 months) compared with the placebo plus EC group (11.58 months) (hazard ratio for death, 0.799; 95% CI, 0.652–0.979; p = 0.0158). The median progression free survival (PFS) was 5.55 months in the socazolimab plus EC group, prolonging disease progression or death by nearly 1.2 months (5.55 months vs 4.37 months, hazard ratio for progression or death, 0.569; 95% CI, 0.457–0.708; p < 0.0001). 200 (80.3%) patients in the socazolimab plus EC group experienced ≥ grade 3 treatment-related adverse events and 187 (75.7%) patients occurred in the placebo plus EC group. Socazolimab combined with standard EC regimen chemotherapy for first-line treatment of ES-SCLC significantly prolonged overall survival and did not increase the safety risk of treatment.
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