Primary Tumor Resection With Sintilimab and Chemotherapy in Advanced NSCLC

This study is a single-center, randomized, open-label, parallel-group trial designed to evaluate the efficacy and safety of primary tumor resection combined with sintilimab, pemetrexed, and carboplatin in patients with advanced, EGFR/ALK-negative NSCLC. A total of 118 patients will be enrolled and randomly assigned in a 1:1 ratio to one of two treatment groups: one group will receive tumor resection followed by the combination of sintilimab, pemetrexed, and carboplatin, while the other group will receive sintilimab, pemetrexed, and carboplatin without tumor resection. The primary endpoint of the study is progression-free survival (PFS), as assessed by independent radiological review according to RECIST v1.1 criteria. Secondary outcomes include overall survival (OS), objective response rate (ORR), disease control rate (DCR), adverse effects (AEs), serious adverse effects (SAEs) and quality of life (QoL). Statistical analysis will include Kaplan-Meier estimation of median PFS with 95% confidence intervals, log-rank testing for comparing differences between the two treatment groups, and Cox proportional hazards models for calculating hazard ratios. Stratification will be performed based on clinical stage, histological subtype, PD-L1 expression, tumor size, and baseline demographic characteristics. Patients will be followed up until disease progression or death from randomization. The results of this study will provide valuable insights into the potential benefits of combining surgery with anti-PD-1 therapy and chemotherapy for advanced NSCLC.