drugset / Trial / NCT07177105

Primary Tumor Resection With Sintilimab and Chemotherapy in Advanced NSCLC

NCT07177105

Phase 2 Not yet recruiting 118 enrolled Jianxing He
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to evaluate whether resecting the primary tumor can improve the outcomes of treatment with sintilimab and chemotherapy in advanced EGFR/ALK-negative non-small cell lung cancer (NSCLC). Patients will be randomly assigned to one of two groups: one group will undergo primary tumor resection followed by sintilimab, pemetrexed, and carboplatin, while the other group will only receive sintilimab, pemetrexed, and carboplatin. The study will assess progression-free survival, overall survival, treatment response, safety, and the impact of treatment on quality of life. Through this study, we hope to determine whether primary tumor resection can provide additional benefits of anti-PD-1 therapy and chemotherapy for advanced NSCLC.

Timeline

Start
2025-09-10
Primary completion
2028-10-01
Completion
2030-10-01

Drugs

EvaluationDrugModalityDoseRoute
Background Carboplatin Small molecule 5 unknown Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous
Background Sintilimab Monoclonal antibody 200 mg Intravenous