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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-06

Study Completion Date

2029-12-31

Brief Summary

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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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Detailed Description

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Conditions

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NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Therapy

Patients in this group will be treated following the guidelines.

Group Type ACTIVE_COMPARATOR

Standard Therapy

Intervention Type 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

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

Group Type EXPERIMENTAL

Adaptive Therapy

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Adaptive Therapy

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No