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RecruitingNCT05457049Updated Sep 16, 2026

Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD

An observational study in Non Small Cell Lung Cancer, sponsored by Guangdong Association of Clinical Trials. Recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Guangdong Association of Clinical Trials · Observational

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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. Patients who confirm two-round landmark undetectable MRD will be enrolled to be under close MRD and imaging monitoring without any adjuvant therapy. Patients who are MRD positive during the two-round MRD screening period will receive treatment and follow-up in accordance with Clinical Practice Guidelines.

02

Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • Molecular residual disease
  • Adjuvant therapy
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 180 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Guangdong Association of Clinical Trials is the lead sponsor of 53 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Diagnostic testMolecular residual disease test

    OncoMRD Lung

06

What researchers measure

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.

    Time frame: 2 year

Secondary outcomes

  1. 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.

    Time frame: 2 year

  2. 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.

    Time frame: 2 year

  3. 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.

    Time frame: 2 year

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

    The events are defined as disease recurrence or detectable MRD.

    Time frame: 2 year

  5. Two-years disease free survival rates for patients who tested positive for MRD and failed screening during the two-round MRD tests.

    The 2-year DFS rate of patients who tested positive for MRD and failed screening during the two-round MRD tests.

    Time frame: 2 year

07

Study locations

5 of 5 sites recruiting
  • The First People's Hospital of Foshan
    Foshan, Guangdong 528000, China
    Recruiting
  • Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
    Guangzhou, Guangdong 510080, China
    • Wen-Zhao Zhong, MD · Contact
    • Yi-Long Wu, MD · Contact · syylwu@live.cn · +86 20 83827812
    • Yi-Long Wu, MD · Principal investigator
    • Wen-Zhao Zhong, MD · Sub investigator
    Recruiting
  • Shantou Centeral Hospital
    Shantou, Guangdong 515031, China
    Recruiting
  • the First Affiliated Hospital of Shantou University Medical College
    Shantou, Guangdong 515041, China
    Recruiting
  • Zhongshan City People's Hospital
    Zhongshan, Guangdong 528445, China
    Recruiting
08

References and documents

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. PubMed 35543554 ↗
  • Huang Z, He J, Li Y, Xu Z, Peng H, Gao X, Zhou H, Guo J, Yang N. Non-invasive radiogenomic mapping of the SMARCAL1-driven ferroptotic niche is associated with longitudinal MRD-negative surveillance in early-stage NSCLC. Front Immunol. 2026 May 25;17:1835413. doi: 10.3389/fimmu.2026.1835413. eCollection 2026. PubMed 42266691 ↗
  • 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. PubMed 37880076 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05457049
Lead sponsor
Guangdong Association of Clinical Trials
Responsible party
Yi-Long Wu (Principal Investigator, Guangdong Association of Clinical Trials) — Principal investigator
First posted
Jul 13, 2022
Start date
Aug 1, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 16, 2026

Study contacts

Yi-Long Wu, M.D
Contact
syylwu@live.cn
020-83827812
Xue-Ning Yang, Ph.D
Contact
yangxuening@gdph.org.cn
020-83827812

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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