This multicentre, two-arm, phase 2 study aimed to explore the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy or apatinib in patients with initially unresectable stage II–III non-small-cell lung cancer (NSCLC). Eligible patients regardless of PD-L1 expression received neoadjuvant camrelizumab 200 mg and platinum-doublet chemotherapy every 3 weeks (arm A) or those with PD-L1-positive tumors received neoadjuvant camrelizumab and apatinib 250 mg once daily (arm B), for 2–4 cycles, followed by surgery. The primary endpoint was major pathological response (MPR) rate. Thirty patients in arm A and 21 in arm B were enrolled. Surgery rates were 50.0% (15/30) in arm A and 42.9% (9/21) in arm B, with all patients achieving R0 resections. Of these patients, the MPR and pathological complete response rates were both 20.0% (95% CI 4.3–48.1) in arm A and were 55.6% (95% CI 21.2–86.3) and 11.1% (95% CI 0.3–48.2) in arm B, respectively. The corresponding objective response rates were 33.3% (95% CI 11.8–61.6) and 55.6% (95% CI 21.2–86.3). With a median follow-up of 22.4 months (95% CI 19.0–26.0), the median event-free survival was not reached (NR; 95% CI 13.6-NR) in arm A and 16.8 months (95% CI 8.6-NR) in arm B. Grade 3 or above treatment-related adverse events occurred in eight (26.7%) patients in arm A and three (14.3%) in arm B. Biomarker analysis showed baseline TYROBP expression was predictive of treatment response in arm B. Neoadjuvant camrelizumab plus chemotherapy or apatinib exhibits preliminary efficacy and manageable toxicity in patients with initially unresectable stage II–III NSCLC.

这项多中心、双臂、2 期研究旨在探讨新辅助卡瑞利珠单抗联合化疗或阿帕替尼治疗最初不可切除的 II-III 期非小细胞肺癌 (NSCLC) 患者的疗效和安全性。符合条件的患者，无论 PD-L1 表达如何，每 3 周接受新辅助卡瑞利珠单抗 200 mg 和铂类双药化疗（A 组），或 PD-L1 阳性肿瘤患者每天接受一次新辅助卡瑞利珠单抗和阿帕替尼 250 mg（B 组），持续 2 次。 –4 个周期，然后进行手术。主要终点是主要病理缓解（MPR）率。 A 组有 30 名患者，B 组有 21 名患者。 A 组的手术率为 50.0% (15/30)，B 组的手术率为 42.9% (9/21)，所有患者均实现 R0 切除。在这些患者中，A 组的 MPR 和病理完全缓解率均为 20.0% (95% CI 4.3–48.1)，而 A 组的 MPR 和病理完全缓解率分别为 55.6% (95% CI 21.2–86.3) 和 11.1% (95% CI 0.3–48.2)。分别为B臂。相应的客观缓解率为 33.3% (95% CI 11.8–61.6) 和 55.6% (95% CI 21.2–86.3)。中位随访时间为 22.4 个月（95% CI 19.0–26.0），A 组未达到中位无事件生存期（NR；95% CI 13.6-NR），而 A 组为 16.8 个月（95% CI 8.6-NR）。 ）在 B 组中。A 组中的 8 名患者（26.7%）和 B 组中的 3 名患者（14.3%）发生了 3 级或以上的治疗相关不良事件。生物标志物分析显示基线 TYROBP 表达可预测 B 组的治疗反应。新辅助卡瑞利珠单抗联合化疗或阿帕替尼对最初不可切除的 II-III 期 NSCLC 患者显示出初步疗效和可控制的毒性。