Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD

NCT05457049 | Unknown

• 1 other identifier: CTONG 2201
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Molecular residual disease; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Two-years disease free survival rates for patients with six months longitudinal undetectable MRD

  2 year

• Two-years disease free survival rates for patients with 12-months longitudinal undetectable MRD

  2 year

• Two-years disease free survival rates for patients with 18-months longitudinal undetectable MRD

  2 year

• Two-years event-free survival rates for enrolled patients in two years

  2 year

Study Arms (1)

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

Interventions

Molecular residual disease test DIAGNOSTIC_TEST

OncoMRD Lung

Undetectable MRD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

Study Sites (1)

Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 35543554 BACKGROUND

• Zhang JT, Dong S, Gu WQ, Zhao N, Liang Y, Tang WF, Liu SY, Wang F, Wang GS, Peng B, Wu N, Yan S, Geng GJ, Xie ZF, Yang YL, Zhang JH, Zhang T, Yang N, Jiao WJ, Xiong YY, Cai M, Li F, Chen RR, Yan HH, Maggie Liu SY, Yi X, Zhong WZ, Yang XN, Wu YL. Adjuvant Therapy-Free Strategy for Stage IB to IIIA Non-Small-Cell Lung Cancer Patients After Radical Resection Based on Longitudinal Undetectable Molecular Residual Disease: Prospective, Multicenter, Single-Arm Study (CTONG 2201). Clin Lung Cancer. 2024 Jan;25(1):e1-e4. doi: 10.1016/j.cllc.2023.09.008. Epub 2023 Oct 6.

  PMID: 37880076 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Every MRD test will take 20ml peripheral blood for DNA extraction.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yi-Long Wu, M.D

CONTACT

020-83827812; syylwu@live.cn

Xue-Ning Yang, Ph.D

CONTACT

020-83827812; yangxuening@gdph.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2022
• First Posted: July 13, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2025
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

CN (1)