Phase II Study of Adjuvant Sintilimab Therapy Guided by Minimal Residual Disease in Patients With Stage II-IIIB Non-Small Cell Lung Cancer After Neoadjuvant Immunotherapy and Chemotherapy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of adjuvant sintilimab therapy guided by minimal residual disease MRD in patients with Stage II to IIIB non-small cell lung cancer NSCLC who did not achieve a complete pathological response after receiving neoadjuvant immunotherapy combined with chemotherapy. This is a multicenter, prospective, open-label Phase II trial led by the Guangdong Association of Clinical Trials, aiming to improve outcomes in NSCLC patients post-surgery. Eligible patients undergo two MRD tests after surgeryone between 3 to 7 days and another around 28 days post-operation. Those with positive MRD results receive sintilimab infusions 200 mg intravenously every three weeks for up to 18 cycles, with treatment continuing or stopping based on subsequent MRD test results. Patients with negative MRD results enter a follow-up observation period with chest CT scans and MRD testing every three months sintilimab treatment starts if MRD becomes positive during follow-up. Participants will be monitored through regular chest CT scans and MRD tests every three months during follow-up. Researchers will assess safety through adverse events and lab tests, and measure outcomes such as the two-year event-free survival rate. The study includes long-term monitoring of overall survival and quality of life for up to 24 months, with some assessments extending to 100 months after enrollment.

Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)