Observational Strategy for Resected NSCLC Patients With Longitudinal Undetectable MRD

Sponsor

Guangdong Association of Clinical Trials (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05457049

Collaborator

(none)

180

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Molecular residual disease (MRD) has strong relationship with clinical outcome in multiple solid tumors. Here, we 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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Diagnostic Test: Molecular residual disease test

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 Design

Study Type:

Observational

Anticipated Enrollment :

180 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Dynamic Observational Strategy for Stage IB-IIIA Non-Small Cell Lung Cancer Patients After Complete Resection Based on Longitudinal Undetectable Molecular Residual Disease: Prospective, Multicenter, Single-Arm Study

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Undetectable MRD 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.	Diagnostic Test: Molecular residual disease test OncoMRD Lung

Arm

Intervention/Treatment

Undetectable MRD

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.

Diagnostic Test: Molecular residual disease test

OncoMRD Lung

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Guangdong Association of Clinical Trials

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Zhang JT, Liu SY, Gao W, Liu SM, Yan HH, Ji L, Chen Y, Gong Y, Lu HL, Lin JT, Yin K, Jiang BY, Nie Q, Liao RQ, Dong S, Guan Y, Dai P, Zhang XC, Yang JJ, Tu HY, Xia X, Yi X, Zhou Q, Zhong WZ, Yang XN, Wu YL. Longitudinal Undetectable Molecular Residual Disease Defines Potentially Cured Population in Localized Non-Small Cell Lung Cancer. Cancer Discov. 2022 Jul 6;12(7):1690-1701. doi: 10.1158/2159-8290.CD-21-1486.

Responsible Party:

Yi-Long Wu, Principal Investigator, Guangdong Association of Clinical Trials

ClinicalTrials.gov Identifier:

NCT05457049

Other Study ID Numbers:

CTONG 2201

First Posted:

Jul 13, 2022

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yi-Long Wu, Principal Investigator, Guangdong Association of Clinical Trials

Molecular residual disease

Adjuvant therapy

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jul 13, 2022