Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC.

Summary

This is an open-label, randomized, controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of spatially fractionated stereotactic body radiotherapy (SF-SBRT) combined with toripalimab and platinum-based chemotherapy versus toripalimab combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage II-III non-small cell lung cancer (NSCLC). Eligible participants will be randomized 2:1 to receive either neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy for two cycles, or toripalimab and platinum-based chemotherapy for three cycles. Randomization will be stratified by disease stage and histological subtype. Surgery is planned 4-6 weeks after completion of neoadjuvant treatment, and postoperative adjuvant therapy will be determined by the investigator. The primary endpoint is the 2-year event-free survival rate. Secondary endpoints include pathological complete response rate, major pathological response rate, objective response rate, R0 resection rate, event-free survival, overall survival, and safety. Adverse events will be assessed according to NCI CTCAE version 5.0 or later.

Timeline

Start

2026-05

Primary completion

2029-05

Completion

2030-05

Drugs

Indications