Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC

Summary

This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.

Timeline

Start

2022-12-02

Primary completion

2024-12-31

Completion

2026-12-31

Publications

• Cai G, Song P, Wang Z, Zhao J, Wang K, Li M, Wang X, Zhu J, Xu J, Huang B, Han X, Zhou H, Xie C, Fu S, Jia H, Teng F, Wang S, Sun H, Li W, Yu J, Meng X. Neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB non-small cell lung cancer: integrated multidimensional biomarker analysis from a phase II study. J Immunother Cancer. 2026 Jun 19;14(6):e015604. doi: 10.1136/jitc-2026-015604.
• Wang K, Wang X, Meng X, Zhang G, Cai G. Molecular imaging using 18F-FDG PET/CT and circulating inflammatory and immune indicators to predict pathological response to neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB NSCLC. Ann Nucl Med. 2025 Aug;39(8):862-874. doi: 10.1007/s12149-025-02057-0. Epub 2025 May 10.

Drugs

Indications