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

NCT06924710 | Recruiting

• 2 other identifiers: 2024KT205ZLRK202524
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Keywords

MRD; ctDNA

Outcome Measures

Primary Outcomes (1)

• Two-years disease free survival rates

  The 2-year DFS rate of patients in both arms

  2 years

Secondary Outcomes (3)

• Use of adjuvant therapy

  2 years

• Questionnaire on Quality of Life

  2 years

• Five-years disease free survival rates

  5 years

Study Arms (2)

Standard Therapy

ACTIVE COMPARATOR

Patients in this group will be treated following the guidelines.

Drug: Standard Therapy

Adaptive Therapy

EXPERIMENTAL

Patients in this group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative.

Other: Adaptive Therapy

Interventions

Standard Therapy DRUG

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.

Standard Therapy

Adaptive Therapy OTHER

Patients will be under close MRD and imaging monitoring without adjuvant therapy if the MRD was negative.

Adaptive Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Tianjin Chest Hospital: collaborator
• Peking University First Hospital: collaborator
• Bethune First Hospital of Jilin University: collaborator
• Beijing Friendship Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Geneplus-Beijing Co. Ltd.: collaborator

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shaohua Ma, M.D.

  Peking University Cancer Hospital & Institute, Beijing 100142, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luyan Shen, Ph.D.

CONTACT

86-1581140843; shenluyan@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 11, 2025
• Study Start: April 6, 2025
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)