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MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Sponsor: Peking University People's Hospital
Summary
This study is a prospective single-arm clinical trial targeting patients with stage IB-IIIA non-small cell lung cancer (NSCLC) who have received neoadjuvant immunotherapy. The primary objective is to evaluate whether a personalized follow-up and adjuvant treatment strategy-based on the combination of ctDNA-based minimal residual disease (MRD) testing and pathological response-can effectively improve the 2-year postoperative recurrence-free survival (RFS). The study will enroll 100 patients scheduled for radical surgery who have undergone neoadjuvant immunotherapy (in combination with platinum-based chemotherapy). Patients will receive individualized follow-up and adjuvant therapy based on dynamic changes in ctDNA at various preoperative and postoperative timepoints, as well as pathological response. Adjuvant therapy will be recommended if patients do not achieve pathological complete response (pCR) after surgery, or if ctDNA testing is positive after neoadjuvant therapy or post-surgery. Only patients who achieve pCR and have negative ctDNA at both specified timepoints will forgo adjuvant therapy; these patients will undergo blood sampling at each routine follow-up, with adjuvant therapy initiated upon ctDNA seroconversion to positive. The primary endpoint is 2-year RFS after surgery; secondary endpoints include overall survival (OS) and the diagnostic rate of recurrence/metastasis based on ctDNA-MRD testing. This project aims to explore the refinement of adaptive treatment strategies in the neoadjuvant immunotherapy lung cancer population, with the ultimate goal of improving overall therapeutic efficacy and establishing a standardized, integrated postoperative management system suitable for lung cancer patients.
Official title: Establishment of Post-Operative Optimal Surveillance Model and Adaptive Treatment Decision System Based on MRD Molecular Response Combined With Pathological Response Status
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-08-12
Completion Date
2027-10-31
Last Updated
2026-10-26
Healthy Volunteers
No
Interventions
Adaptive therapy of de-escalation and escalation based on MRD testing and pathological response
Postoperative adjuvant therapy is administered if any of the following criteria are met: absence of pathological complete response (pCR), positive preoperative ctDNA after neoadjuvant therapy, or positive postoperative ctDNA. Treatment regimens are determined by multidisciplinary review. Monthly blood sampling is performed during adjuvant therapy. Based on current evidence, treatment de-escalation based solely on ctDNA status is not supported in lung cancer patients receiving neoadjuvant immunotherapy. Thus, patients achieving pCR with negative ctDNA at both predefined timepoints receive no adjuvant therapy. Blood is collected at routine follow-up visits, and adjuvant therapy is initiated upon ctDNA seroconversion to positive.
Locations (1)
Peking University People's Hospital
Beijing, Beijing Municipality, China