NCT06924710

Adaptive Therapy for Resected Stage ⅠA2-Ⅱ NSCLC Patients With Undetectable MRD

A Prospective Multicenter Randomized Controlled Study of Adaptive Therapy in Resected Stage ⅠA2-Ⅱ NSCLC Patients With Undetectable MRD

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is a prospective, multicenter, randomized controlled trial to investigate the predictive value of MRD on adjuvant therapy. Stage IA2-II resected NSCLC patients will undergo two-round MRD tests after surgery, first in 3-7 days and second in 1 month after surgery. And patients who confirm two-round landmark undetectable MRD will be enrolled and randomly assigned to the conventional treatment group or the adaptive therapy group . Patients in the the adaptive therapy group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Standard Therapy	For patients with negative EGFR/ALK mutation, adjuvant chemotherapy or adjuvant chemotherapy combined with immunotherapy was administered, for patients with positive EGFR/ALK mutation, targeted therapy was administered.
OTHER	Adaptive Therapy	Patients will be under close MRD and imaging monitoring without adjuvant therapy if the MRD was negative.

Timeline

• Start date: 2025-04-06
• Primary completion: 2029-06-15
• Completion: 2029-12-31
• First posted: 2025-04-11
• Last updated: 2025-10-02

Locations

1 site across 1 country: China