Neoadjuvant camrelizumab plus chemotherapy or apatinib for resectable stage IIA–IIIA NSCLC: a multicenter, two-arm, phase II exploratory trial

BACKGROUND: This study aimed to evaluate the efficacy and safety of camrelizumab, an anti-PD-1 antibody, combined with either chemotherapy or apatinib, a VEGFR-2 inhibitor, as neoadjuvant treatment for stage IIA-IIIA NSCLC. METHODS: This prospective, multicenter, dual-arm, non-randomized phase II trial enrolled participants from four hospitals in China between September 2020 and March 2022. Patients received 2-4 cycles of neoadjuvant treatment followed by surgery. Arm-AR (n = 28) included patients treated with camrelizumab (200 mg every 3 weeks) plus platinum-based chemotherapy, regardless of PD-L1 status. Arm-BR (n = 10) included PD-L1-positive patients treated with camrelizumab (200 mg every 3 weeks) plus apatinib (250 mg daily). The primary endpoint was the major pathological response (MPR) rate. Secondary endpoints included pathological complete response (pCR) rate, objective response rate (ORR), disease control rate (DCR), event-free survival (EFS), overall survival (OS), and safety profiles. RESULTS: In the ITT population, MPR rates were 25.0% (95% CI 10.7-44.9) in arm-AR and 60.0% (95% CI 26.2-87.8) in arm-BR. The 24-month EFS rates were 53.6% and 70.0%, respectively, after a median follow-up of 30.5 months. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 25% of arm-AR patients and 10% of arm-BR patients. CONCLUSIONS: Camrelizumab combined with platinum-based chemotherapy demonstrated promising efficacy and tolerability for resectable IIA-IIIA NSCLC, regardless of PD-L1 status. In PD-L1-positive patients, camrelizumab plus apatinib showed improved safety and effectiveness, highlighting a potential treatment option for this subgroup. TRIAL REGISTRATION: NCT04379739, initiated on July 26, 2020.