Chen Zhiwei, Chen Jianhua, Huang Dingzhi, Zhang Wei, Wu Lin, Yi Tienan, Wang Qiming, Han Liang, Tan Liping, Li Yinyin, Zhang Zhihong, Li Na, Li Jie, Zhang Tongmei, Hu Ying, Sun Hongmei, Wu Youhua, He Zhiyong, Yang Runxiang, Cheng Peng, Li Xingya, Shi Jianhua, Yu Guohua, Ma Daiyuan, Li Benjamin Xiaoyi, Dai Xiangrong, Wong Michael, Li Yujie, Yu Xiaohui, Lu Shun
Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Medical Oncology, Hunan Cancer Hospital, Changsha, China.
Signal Transduct Target Ther. 2025 Jan 13;10(1):28. doi: 10.1038/s41392-024-02115-5.
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.
这是一项在中国54家医院开展的随机、双盲、安慰剂对照3期临床试验（ClinicalTrials.gov，NCT04878016）。纳入组织学确诊且从未接受过广泛期小细胞肺癌（ES-SCLC）治疗的成年人。符合条件的患者被随机分配（1:1）接受四个周期（21天为一个周期）的静脉注射卡铂（每个周期第1天，曲线下面积为5mg/mL每分钟）和依托泊苷（每个周期第1 - 3天，体表面积100mg/m²），同时联合索卡唑单抗（每个周期第1天，5mg/kg）或匹配的安慰剂，之后接受索卡唑单抗或安慰剂维持治疗。从2021年7月15日至2022年5月12日，498例符合条件的患者被随机分配接受索卡唑单抗（250例患者）或安慰剂（248例患者）联合化疗。截至2023年10月13日，与安慰剂加EC组（11.58个月）相比，接受索卡唑单抗治疗的患者总生存期（OS）有显著获益（13.90个月）（死亡风险比，0.799；95%置信区间，0.652 - 0.979；p = 0.0158）。索卡唑单抗加EC组的中位无进展生存期（PFS）为5.55个月，疾病进展或死亡时间延长近1.2个月（5.55个月对4.37个月，进展或死亡风险比，0.569；95%置信区间，0.457 - 0.708；p < 0.0001）。索卡唑单抗加EC组200例（80.3%）患者发生≥3级治疗相关不良事件，安慰剂加EC组有187例（75.7%）患者发生。索卡唑单抗联合标准EC方案化疗一线治疗ES-SCLC可显著延长总生存期且未增加治疗安全风险。
