Camrelizumab Combined With SRT/WBRT and Chemotherapy in Patients With Brain Metastases of Driven Gene-negative NSCLC

Summary

This study is a randomized, double-blind, placebo-controlled, multi-center clinical study. Target population is patients with stage IV non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of Camrelizumab + carboplatin/cisplatin + pemetrexed /paclitaxel / albumin paclitaxel ± SRT/WBRT with placebo + carboplatin/cisplatin + pemetrexed /paclitaxel / albumin paclitaxel ± SRT/WBRT. Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Timeline

Start

2021-05-28

Primary completion

2026-03-01

Completion

2026-04-30

Outcome

Mixed primary results

paper median iPFS was 12.7 months (95% confidence interval [CI]: 7.1-25.3) for camrelizumab versus 9.9 months PMID 39929333 ↗

paper for placebo (hazard ratio = 0.45, 95% CI: 0.21-0.96). PMID 39929333 ↗

paper 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) PMID 39929333 ↗

Publications

• Li YS, Yu Q, Bu Q, Lin L, Ning F, Zhao Y, Wu G, Lin G, Zang A, Sun H, Huang J, Tu HY, Ma S, Zhou C, Liu A, Wang C, Yao Y, Han G, Zhao J, Zhou Q, Yan HH, Liu SM, Zheng MM, Lv J, Cheng F, Chen Z, Zhong WZ, Pan Y, Yang JJ, Wu YL. First-Line Camrelizumab Versus Placebo Plus Chemotherapy With or Without Radiotherapy for Brain Metastases in NSCLC: The CTONG 2003 Randomized Placebo-Controlled Trial. J Thorac Oncol. 2025 Jul;20(7):928-940. doi: 10.1016/j.jtho.2025.02.004. Epub 2025 Feb 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Camrelizumab	Monoclonal antibody	—	Intravenous
Background	Albumin paclitaxel	Unknown	—	Intravenous
Background	Carboplatin	Small molecule	—	Intravenous
Background	Cisplatin	Other / unclassified	—	Intravenous
Background	Paclitaxel	Small molecule	—	Intravenous
Background	Pemetrexed	Small molecule	—	Intravenous

Indications