Using ctDNA to Guide Toripalimab Treatment After Surgery in Stage IB-IIIA Non-small Cell Lung Cancer Without EGFR or ALK Changes

What this Trial Is About

Researchers are evaluating the use of circulating tumor DNA ctDNA as a marker of minimal residual disease MRD to guide consolidation therapy with toripalimab in patients who have undergone complete surgical removal of stage IB-IIIA non-small-cell lung cancer NSCLC. This study aims to determine if monitoring ctDNA can help personalize treatment, deciding who may benefit from further consolidation therapy after standard adjuvant chemotherapy. Toripalimab, a humanized monoclonal antibody targeting the programmed cell death protein 1, has shown promise in improving outcomes in resectable NSCLC. Participants receive 4 cycles of toripalimab combined with platinum-based chemotherapy after surgery. Following this, patients with undetectable ctDNA enter an observation follow-up group, while those with detectable ctDNA receive consolidation toripalimab therapy for up to 13 cycles. The study compares the outcomes between these groups to explore if observation alone is as effective as additional therapy in certain patients. During the study, participants will undergo regular assessments including ctDNA testing, safety monitoring, and evaluations of disease-free survival over 2 years. Researchers will track adverse events and measure overall survival rates as secondary outcomes. The total follow-up includes observation for up to 24 months, with safety monitoring extending to 36 months to ensure comprehensive evaluation of treatment effects and patient well-being.

ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC