Efficacy and safety of neoadjuvant camrelizumab and apatinib combined with chemotherapy in stage IIIA (N2) NSCLC: a multi-center, single-arm, phase II trial.

Abstract

Camrelizumab (an anti-programmed cell death protein-1 antibody) combined with apatinib (an antiangiogenic agent) has conferred benefits for advanced NSCLC. This study aimed to assess the efficacy and safety of camrelizumab and apatinib alongside chemotherapy in patients with resectable stage IIIA (N2) NSCLC as neoadjuvant therapy. Patients with stage IIIA (N2) NSCLC were treated with a combination of chemotherapy, camrelizumab (200 mg, once every 3 weeks [q3w]), and apatinib (250 mg, once daily). Surgery was planned after 2-4 cycles of therapy. The primary endpoint was major pathological response (MPR) rate, with secondary endpoints including pathological complete response (pCR) rate, R0 resection rate, objective response rate (ORR), and safety. The trial was registered at ChiCTR.org.cn (ChiCTR2200059608). Thirty-one patients were enrolled from August 4, 2021, to October 8, 2023. The disease control rate (DCR) was 93.5%, while the ORR was 87.1% and a clinical down-staging rate of 19.4%. Among them, 20 patients underwent complete resection, the MPR rate was 65.0%, and the pCR rate was 40%. Any grade neoadjuvant adverse events (AEs) were reported in 31 (100%) of the patients, and grade 3/4 AEs in 19 (61.3%). The most common AEs of any grade were fatigue (61.3%), nausea (54.8%), and decreased white blood cell count (51.6%). These conditions typically return to normal within a short period following observation or pharmacological treatment. No treatment-related deaths occurred. The synergistic application of chemotherapy with camrelizumab and apatinib showed clinically meaningful anti-tumor activity and manageable safety, with few hematologic toxicities, and might be a promising therapeutic alternative for individuals with resectable stage IIIA (N2) NSCLC.