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

Not Applicable

Recruiting

• Conditions: NSCLC
• Interventions: Drug: Standard Therapy; Other: Adaptive Therapy

• Registration Number: NCT06924710
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-20
• Status Verified: 2025-04
• Study Start: 2025-04-06
• Study First Submitted QC: 2025-04-06
• Study First Posted: 2025-04-11
• Last Update Submitted: 2025-09-28
• Last Update Posted: 2025-10-02
• Primary Completion: 2029-06-15
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Stage IA2-II non-small cell cancer patients who after complete resection.
• Two-round MRD tests confirm landmark undetectable MRD
• Expected survival ≥24 months
• ECOG PS 0-1
• Willing to accept MRD monitoring every 3 months for a total of 2 years after surgery

Exclusion Criteria

• Patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy
• Patients with a history of other malignancies in the past 5 years
• Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.) or other conditions that investigators considered would limit the ability of the patient to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Therapy	Standard Therapy	Patients in this group will be treated following the guidelines.
Adaptive Therapy	Adaptive Therapy	Patients in this group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative.

Primary Outcome Measures

Name	Time	Method
Two-years disease free survival rates	2 years	The 2-year DFS rate of patients in both arms

Secondary Outcome Measures

Name	Time	Method
Five-years disease free survival rates	5 years	The 5-year DFS rate of patients in both arms
Use of adjuvant therapy	2 years	Differences in adjuvant therapy use between the Adaptive Therapy group (no adjuvant therapy if MRD persistently negative and initiation of adjuvant therapy if MRD positive) and the Standard Treatment Group
Questionnaire on Quality of Life	2 years	Differences in the Quality of Life between the Adaptive Therapy group (no adjuvant therapy if MRD persistently negative and initiation of adjuvant therapy if MRD positive) and the Standard Treatment Group, by using Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, V3)

Trial Locations

Locations (1)

Peking University Cancer Hospital & Institute; 🇨🇳 Beijing, Beijing Municipality, China