First-Line Camrelizumab Versus Placebo Plus Chemotherapy With or Without Radiotherapy for Brain Metastases in NSCLC: The CTONG 2003 Randomized Placebo-Controlled Trial

作者：Yang-Si Li, Qitao Yu, Qing Bu, Lizhu Lin, Fangling Ning, Yun Zhao, Gang Wu, Gen Lin, Aimin Zang, Hao Sun, Jie Huang, Hai-Yan Tu, Shenglin Ma, Chengzhi Zhou, Anwen Liu, Cailian Wang, Yao Yu, Guang Han, Jun Zhao, Qing Zhou, Hong-Hong Yan, Si‐Yang Maggie Liu, Mei-Mei Zheng, Jingye Lv, Fengzhuo Cheng, Zhongjiang Chen, Wen‐Zhao Zhong, Yi Pan, Jin-Ji Yang, Yi‐Long Wu · 发表于：Journal of Thoracic Oncology · 年份：2025 · DOI：10.1016/j.jtho.2025.02.004 · 被引用次数：18 · 研究领域：Brain Metastases and Treatment、Lung Cancer Research Studies、Lung Cancer Treatments and Mutations

INTRODUCTION: Retrospective studies have indicated the potential benefits of immunotherapy for brain metastases (BMs) in NSCLC. To our knowledge, CTONG 2003 is the first randomized controlled trial to evaluate camrelizumab for untreated BM of NSCLC. METHODS: CTONG 2003 is a multicenter, randomized, double-blind, placebo-controlled trial. Treatment-naïve NSCLC with BM, negative for EGFR mutations and ALK fusions, were randomized 1:1 to receive either camrelizumab or placebo, plus platinum-doublet chemotherapy for four to six cycles, followed by maintenance therapy with camrelizumab or placebo with or without pemetrexed for up to 31 cycles. Radiotherapy was administered for BM, if necessary, within 42 days of the first treatment dose. The co-primary endpoints were intracranial progression-free survival (iPFS) and progression-free survival (PFS). The planned enrollment included 200 patients, but recruitment was terminated early because of therapeutic paradigm shifts globally. RESULTS: Between May 28, 2021, and July 21, 2023, 60 patients were randomized, with 32 assigned to the camrelizumab group and 28 to the placebo group. The median iPFS was 12.7 months (95% confidence interval [CI]: 7.1-25.3) for camrelizumab versus 9.9 months (95% CI: 6.3-14.6) for placebo (hazard ratio = 0.45, 95% CI: 0.21-0.96). The median PFS was 9.7 months (95% CI: 6.6-14.0) for camrelizumab versus 6.7 months (95% CI: 4.1-8.6) for placebo (hazard ratio = 0.57, 95% CI: 0.29-1.11). Grade 3 or higher treatm...