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

Peking University Cancer Hospital & Institute286 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

286

Conditions

NSCLC

Interventions

Standard Therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Two-years disease free survival rates

The 2-year DFS rate of patients in both arms

Time frame: 2 years

Secondary Outcomes

Use of adjuvant therapy

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

Time frame: 2 years

Questionnaire on Quality of Life

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)

Time frame: 2 years

Five-years disease free survival rates

The 5-year DFS rate of patients in both arms

Time frame: 5 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts