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NCT Number: NCT06924710

Adaptive Therapy for 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.

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Location contact

Luyan Shen

CONTACT

[email protected]

86-1581140843

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Adaptive Therapy

Other

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

Primary outcomes

  1. Two-years disease free survival rates

    Time frame: 2 years

    The 2-year DFS rate of patients in both arms

Secondary outcomes

  1. Use of adjuvant therapy

    Time frame: 2 years

    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. Questionnaire on Quality of Life

    Time frame: 2 years

    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)

  3. Five-years disease free survival rates

    Time frame: 5 years

    The 5-year DFS rate of patients in both arms

Study contacts

Contact information is provided by the study sponsor or research team.

Luyan Shen, Ph.D.

CONTACT

[email protected]

86-1581140843

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Collaborators

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

Registry information

Official study title

A Prospective Multicenter Randomized Controlled Study of Adaptive Therapy in Resected Stage ⅠA2-Ⅱ NSCLC Patients With Undetectable MRD

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 11, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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