Camrelizumab Plus Apatinib In Extensive-Stage Small-Cell Lung Cancer (Passion): A Multicenter, Two-Stage, Phase 2 Trial

Background: Treatment options in 2nd-line extensive-stage small-cell lung cancer (ED-SCLC) setting are very limited. PASSION (NCT03417895) was a phase 2 study of camrelizumab plus apatinib in ED-SCLC after platinum-based chemotherapy. Methods: In the randomized, open-label, three-parallel-cohort Stage 1, patients (pts) were randomly assigned (1:1:1) to receive intravenous camrelizumab 200 mg every 2 weeks plus oral apatinib 375 mg once daily (QD), 5 days on/2 days off, or 7 days on/7 days off (six pts each cohort). Based on the tolerability during the first 28-day cycle and efficacy data in Stage 1, one cohort was chosen to expand to 45 pts in Stage 2. The primary endpoints were objective response rate (ORR) per RECIST 1.1 and safety. Results: From Apr 20, 2018 to Mar 12, 2019, 59 pts were enrolled, with 47 in the QD cohort. Findings as of Dec 12, 2019 are listed in the table. In the QD cohort, confirmed ORR reached 34.0% (95% CI 20.9-49.3), median progression-free survival (PFS) was 3.6 months (95% CI 1.9-4.6), and median overall survival (OS) was 8.4 months (95% CI 4.7-12.3). Chemo-sensitive and chemo-resistant pts (defined as pts with disease relapsed ≥90 and Citation Format: Jie Wang, Yun Fan, Jun Zhao, Qiming Wang, Dingzhi Huang, Xingya Li, Jianhua Chen, Yong Fang, Zhijie Wang, Caicun Zhou, Yanping Hu, Haihua Yang, Yi Hu, Jianying Zhou, Xiaoyan Lin, Lifeng Wang, Yanjun Xu, Hanying Li. Camrelizumab plus apatinib in extensive-stage small-cell lung cancer (PASSION): A multicenter, two-stage, phase 2 trial [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr CT083.