Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Yi-Long Wu, M.D; Phone Number: 020-83827812; Email: syylwu@live.cn
• Study Contact Backup: Name: Xue-Ning Yang, Ph.D; Phone Number: 020-83827812; Email: yangxuening@gdph.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
      • Contact: Wen-Zhao Zhong, MD
      • Contact: Yi-Long Wu, MD; Phone Number: 51221 +86 20 83827812; Email: syylwu@live.cn
      • Principal Investigator: Yi-Long Wu, MD
      • Sub-Investigator: Wen-Zhao Zhong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Stage IB-IIIA NSCLC patients who after complete resection and undetectable landmark MRD.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two-years disease free survival rates for patients with longitudinal undetectable MRD	The 2-year DFS rate of patients who maintain 2-years undetectable MRD.	2 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangdong Association of Clinical Trials

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: July 9, 2022
• First Submitted That Met QC Criteria: July 9, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Adjuvant therapy; Molecular residual disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CTONG 2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No