NCT06709274

Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC

Minimal Residual Disease (MRD)-Guided Adjuvant Therapy in Stage I Non-Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib	80mg daily, for EGFR-positive patients
DRUG	Alectinib	600mg BID, for ALK-rearranged patients
DRUG	TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy	Toripalimab 240mg + Platinum-based chemotherapy (Q3W for 4 cycles), followed by Toripalimab maintenance therapy (240mg Q3W for one year), for EGFR/ALK wildtype patients

Timeline

• Start date: 2024-11-01
• Primary completion: 2029-01-01
• Completion: 2032-01-01
• First posted: 2024-11-29
• Last updated: 2024-11-29

Locations

15 sites across 1 country: China