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

NCT06924710 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2025-10-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Tianjin Chest Hospital

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • The First Hospital of Jilin University

    collaborator OTHER

  • Beijing Friendship Hospital

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Liaoning Cancer Hospital & Institute

    collaborator OTHER

  • Geneplus-Beijing Co. Ltd.

    collaborator INDUSTRY

  • Peking University Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Shaohua Ma, M.D. · Peking University Cancer Hospital & Institute, Beijing 100142, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-06
Primary Completion
2029-06-15
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06924710 on ClinicalTrials.gov