drugset / Trial / NCT06709274

Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC

NCT06709274

RandomizedParallel-groupOpen-labelTreatment

Summary

This investigator-initiated study aims to evaluate the effectiveness of minimal residual disease (MRD) as a biomarker for guiding adjuvant therapy decisions in patients with Stage I non-small-cell lung cancer (NSCLC). The study will compare outcomes between an MRD-guided management group and a standard-of-care group, focusing on whether the use of MRD information can improve the 3-year disease-free survival rate compared to existing treatment protocols. Participants in the MRD-guided management group will receive targeted therapy, immunotherapy, or observation based on their postoperative MRD status, while those in the standard-of-care group will receive treatments or observation according to current clinical guidelines.

Timeline

Start
2024-11
Primary completion
2029-01
Completion
2032-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Alectinib Small molecule 600 mg
Subject Osimertinib Small molecule 80 mg
Subject Toripalimab Monoclonal antibody 240 mg