A Phase II Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade (PD-1/CTLA-4) in Patients With Locally Advanced Non-Small Cell Lung Cancer
This study will enroll patients with locally advanced non-small cell lung cancer (NSCLC). Patients will receive neoadjuvant chemotherapy combined with dual immune checkpoint blockade (PD-1/CTLA-4), bevacizumab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with dual immune checkpoint blockade (PD-1/CTLA-4), surufatinib and thymosin alpha 1. The study aims to evaluate the efficacy and safety of this treatment regimen.
• Males or females aged 18 to 75 years or older;
• Patients must have histologically or cytologically confirmed locally advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC);
• EGFR, ALK, and ROS1 wild-type;
• No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy;
• Expected survival ≥ 12 weeks;
• WHO Performance Status (PS) score of 0 or 1;
• Female subjects must not be breastfeeding;
• Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment and for 5 months after the last dose of study drug (i.e., 30 days \[one ovulation cycle\] plus approximately five half-lives of the study drug);
• Adequate organ and bone marrow function as defined by the following criteria:
• Forced Expiratory Volume in 1 second (FEV1) ≥ 800 mL;
• Absolute neutrophil count ≥ 1.5 × 10⁹/L;
• Platelets ≥ 100 × 10⁹/L;
• Hemoglobin ≥ 9.0 g/dL;
• Creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976);
• Serum bilirubin ≤ 1.5 × upper limit of normal (ULN);
• AST and ALT ≤ 2.5 × ULN.