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
Peking University Cancer Hospital & Institute
286 participants
Apr 6, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria3
- 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
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Interventions
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.
Patients will be under close MRD and imaging monitoring without adjuvant therapy if the MRD was negative.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06924710