Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD

NCT ID: NCT05457049

Last Updated: 2022-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-08-01

Brief Summary

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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

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Molecular residual disease test

Intervention Type DIAGNOSTIC_TEST

OncoMRD Lung

Interventions

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Molecular residual disease test

OncoMRD Lung

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Association of Clinical Trials

OTHER

Sponsor Role lead

Responsible Party

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Yi-Long Wu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi-Long Wu, M.D

Role: CONTACT

020-83827812

Xue-Ning Yang, Ph.D

Role: CONTACT

020-83827812

Facility Contacts

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Wen-Zhao Zhong, MD

Role: primary

Yi-Long Wu, MD

Role: backup

+86 20 83827812 ext. 51221

References

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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.

Reference Type BACKGROUND
PMID: 35543554 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37880076 (View on PubMed)

Other Identifiers

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CTONG 2201

Identifier Type: -

Identifier Source: org_study_id

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