Evaluating Adjuvant Sintilimab Versus Observation After Surgery and Neoadjuvant Immunochemotherapy in Patients with High-Risk Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are investigating the effects of adjuvant sintilimab treatment in patients with non-small cell lung cancer NSCLC who have undergone surgery after receiving neoadjuvant immunochemotherapy and remain at high risk of cancer recurrence. This phase II, randomized, open-label trial seeks to clarify the benefits and safety of adding postoperative immune checkpoint inhibitor therapy to standard care in this patient group. Participants will be randomly assigned to one of two groups one receiving sintilimab 200 mg by intravenous infusion every 4 weeks for up to 1 year, and the other under observation without additional immune checkpoint inhibitor therapy. Treatment will continue unless the disease recurs, unacceptable side effects occur, participants withdraw consent, or other criteria for stopping arise. Both groups will be monitored regularly for disease recurrence, survival, and side effects. During the study, participants will undergo evaluations including blood and tumor tissue sample collection to analyze immune responses and molecular markers. The primary outcome measured is the rate of disease-free survival at 18 months post-surgery. Secondary outcomes include overall survival, safety, and disease-free survival over up to 36 months. Participants will be assessed for adverse events from the start of treatment through 30 days after completion or discontinuation, with follow-up continuing for up to one year.

Adjuvant Immune Checkpoint Inhibitor Versus Observation After Neoadjuvant Immunochemotherapy and Surgery in High-Risk NSCLC