Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD

Recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Diagnostic Test: Molecular residual disease test

• Registration Number: NCT05457049
• Lead Sponsor: Guangdong Association of Clinical Trials

Brief Summary

Molecular residual disease (MRD) has strong relationship with clinical outcome in multiple solid tumors. Here, the investigators try to verify the negative predictive value of undetectable MRD, which is considered as a superior prognostic factor for resected NSCLC patients, and not requiring excessive adjuvant therapy. Stage IB-IIIA resected NSCLC patients with landmark and longitudinal undetectable MRD are enrolled and under close surveillance in this study.

Detailed Description

Stage IB-IIIA resected NSCLC patients will undergo two-round MRD tests after operation, first in 3-7 days and second in 1 month after operation. And patients who confirm two-round landmark undetectable MRD will be enrolled. Enrolled patients will be under close MRD and imaging monitoring without any adjuvant therapy.

Study Timeline

• Study First Submitted: 2022-07-09
• Study First Submitted QC: 2022-07-09
• Study First Posted: 2022-07-13
• Study Start: 2022-08-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29
• Primary Completion: 2023-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Stage IB-IIIA non-small cell cancer patients who after complete resection.
• ≥18 years.
• Two-round MRD tests confirm landmark undetectable MRD.
• Expected survival ≥12 weeks.
• Expected survival ≥12 weeks.
• ECOG PS 1-2.
• Willing to accept MRD monitoring every 3 months for a total of 2 years after operation.

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.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Undetectable MRD	Molecular residual disease test	Stage IB-IIIA NSCLC patients who after complete resection. And patients who maintain MRD negativity in two-round MRD landmark test (first in 3-7 days after surgery, second in 1 months ±7 days after surgery) will be enrolled. And patients will be under close dynamic monitoring at least two years.

Primary Outcome Measures

Name	Time	Method
Two-years disease free survival rates for patients with longitudinal undetectable MRD	2 year	The 2-year DFS rate of patients who maintain 2-years undetectable MRD.

Secondary Outcome Measures

Name	Time	Method
Two-years disease free survival rates for patients with 18-months longitudinal undetectable MRD	2 year	The 2-year DFS rate of patients who maintain 18-months undetectable MRD.
Two-years event-free survival rates for enrolled patients in two years	2 year	The events are defined as disease recurrence or detectable MRD.
Two-years disease free survival rates for patients with six months longitudinal undetectable MRD	2 year	The 2-year DFS rate of patients who maintain 6-months undetectable MRD.
Two-years disease free survival rates for patients with 12-months longitudinal undetectable MRD	2 year	The 2-year DFS rate of patients who maintain 12-months undetectable MRD.

Trial Locations

Locations (1)

Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences; 🇨🇳 Guangzhou, Guangdong, China