Efficacy and safety of a low-dose nivolumab regimen (240 mg) as neoadjuvant immunochemotherapy in Chinese patients with resectable non-small cell lung cancer: a prospective single-arm, exploratory study.

[BACKGROUND] Neoadjuvant immunotherapy has gained increasing importance in the multidisciplinary management of resectable Non-Small Cell Lung Cancer (NSCLC). Based on the CheckMate 816 trial, this study aimed to evaluate the efficacy and safety of neoadjuvant nivolumab in Chinese patients with NSCLC.

[METHODS] This prospective, exploratory, single-arm study enrolled patients with stage IB-IIIA NSCLC. Participants received three cycles of neoadjuvant nivolumab (240 mg) plus platinum-based chemotherapy. The primary endpoints were pathological complete response (pCR) rate and event-free survival (EFS), which were descriptively analyzed and contextualized with historical data from the CheckMate 816 trial (nivolumab 360 mg) as an external reference. The secondary endpoints included major pathological response (MPR) rate and overall survival (OS).

[RESULTS] As of September 30, 2025, a total of 37 eligible patients were screened. Among them, 30 completed three cycles of neoadjuvant immunotherapy as planned, and 23 ultimately underwent surgical resection. One patient postponed surgery due to personal reasons, and no patients experienced surgical delay or cancellation due to treatment-related adverse events (TRAEs). Eight (21.6%) patients developed Grade 3 or 4 TRAEs. Pathological evaluation revealed that the pCR rate was 43.3% and the MPR rate was 56.7%. The median follow-up time was 25.5 months (interquartile range [IQR]: 3.0-31.7). The estimated 2-year EFS rate was 56.1% (95% confidence interval [CI]: 38.3%-73.9%), and the 2-year disease-free survival (DFS, defined as the time from surgery to recurrence or death) rate was 66.6% (95% CI: 56.4%-86.8%). The pCR rate was 43.3%, which was numerically higher than that reported in CheckMate 816 (24.0%), though formal statistical comparison was not performed due to the single-arm design.

[CONCLUSION] In Chinese patients with potentially resectable NSCLC, neoadjuvant therapy with low-dose nivolumab (240 mg) combined with chemotherapy followed by surgery demonstrated promising efficacy and a manageable safety profile. Although formal statistical comparison was not performed due to the single-arm design, the observed pCR (43.3%) and EFS rates were numerically comparable to those reported with the higher-dose nivolumab (360 mg) regimen in the CheckMate 816 trial, while the incidence of adverse events was numerically lower. These preliminary findings suggest that a reduced-dose nivolumab regimen may maintain antitumor activity with potentially improved tolerability, offering a clinically relevant option for Chinese patients. Further validation in larger, randomized controlled studies is warranted.