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

Peking University Cancer Hospital & Institute

Status: Enrolling

Conditions: NSCLC

Treatments: Drug: Standard Therapy; Other: Adaptive Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06924710

ZLRK202524 (Other Grant/Funding Number)

2024KT205

Details and patient eligibility

About

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.

Enrollment: 286 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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286 participants in 2 patient groups

Standard Therapy

Active Comparator group

Description:

Patients in this group will be treated following the guidelines.

Treatment:

Drug: Standard Therapy

Adaptive Therapy

Experimental group

Description:

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

Treatment:

Other: Adaptive Therapy