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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC
• Intervention / Treatment: Other: Adaptive Therapy; Drug: Standard Therapy

• Study Type: Interventional
• Enrollment (Estimated): 286
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luyan Shen, Ph.D.; Phone Number: 86-1581140843; Email: shenluyan@pku.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Peking University Cancer Hospital & Institute
      • Contact: Luyan Shen; Phone Number: 86-1581140843; Email: shenluyan@pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Therapy; Patients in this group will be treated following the guidelines.	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.
Experimental: Adaptive Therapy; Patients in this group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative.	Other: Adaptive Therapy; Patients will be under close MRD and imaging monitoring without adjuvant therapy if the MRD was negative.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two-years disease free survival rates	The 2-year DFS rate of patients in both arms	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of adjuvant therapy	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	2 years
Questionnaire on Quality of Life	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)	2 years
Five-years disease free survival rates	The 5-year DFS rate of patients in both arms	5 years

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Collaborators: Peking University First Hospital; Beijing Friendship Hospital; The First Hospital of Jilin University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Tianjin Chest Hospital; Geneplus-Beijing Co. Ltd.; Liaoning Cancer Hospital & Institute
• Investigators: Principal Investigator: Shaohua Ma, M.D., Peking University Cancer Hospital & Institute, Beijing 100142, China

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2025
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: ctDNA; MRD
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2024KT205; ZLRK202524 (Other Grant/Funding Number: Beijing Hospitals Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No