Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05457049
• Other study ID #: CTONG 2201
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: September 2022
• Source: Guangdong Association of Clinical Trials
• Contact: Yi-Long Wu, M.D
• Phone: 020-83827812
• Email: syylwu[@]live.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Diagnostic Test:
• Molecular residual disease test
OncoMRD Lung

Locations

Country	Name	City	State
China	Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Two-years event-free survival rates for enrolled patients in two years	The events are defined as disease recurrence or detectable MRD.	2 year