Non Small Cell Lung CancerNCT05457049
Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD
An observational study of Non Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 5 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Molecular residual disease test
- How many people
- 180 participants
- Where
- 5 sitesChina
- Study dates
- 1 Aug 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage IB-IIIA NSCLC patients who after complete resection and undetectable landmark MRD.
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Weiquan Gu, 086-0757-83163155, gwquan@fsyyy.com
- Recruiting
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080
Wen-Zhao Zhong, MD
Yi-Long Wu, MD, +86 20 83827812 ext. 51221, syylwu@live.cn
- Recruiting
Shantou Centeral Hospital
Shantou, Guangdong, 515031
Yanlong Yang, 086-0754-88550450, styylong@163.com
- Recruiting
the First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Zefeng Xie, 086-0754-88258290, zefengxie@sina.com
- Recruiting
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528445
Yi Liang, MD, 086-0760-88823566, yiliang2020@qq.com
About this study
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
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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Molecular residual disease test
- Keywords
- Molecular residual disease, Adjuvant therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular residual disease testDiagnostic test
OncoMRD Lung
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Molecular residual disease test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 year
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 2 year
Two-years event-free survival rates for enrolled patients in two years
The events are defined as disease recurrence or detectable MRD.
Measured: 2 year
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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Long Wu, Guangdong Association of Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457049
- Sponsor's protocol ID
- CTONG 2201
- Status last verified
- Mar 2026
- First submitted
- 9 Jul 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 35543554Huang 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 42266691Zhang 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05457049
- Acronym / sponsor ID
- CTONG 2201
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Molecular residual disease, Adjuvant therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undetectable MRD | – | Diagnostic Test: Molecular residual disease testStage 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage IB-IIIA NSCLC patients who after complete resection and undetectable landmark MRD.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular residual disease testOncoMRD Lung | Diagnostic test | Undetectable MRD |
Primary outcome
Two-years disease free survival rates for patients with longitudinal undetectable MRD
Time frame: 2 year
The 2-year DFS rate of patients who maintain 2-years undetectable MRD.
5 secondary outcomes
Two-years disease free survival rates for patients with six months longitudinal undetectable MRD
Time frame: 2 year
Two-years disease free survival rates for patients with 12-months longitudinal undetectable MRD
Time frame: 2 year
Two-years disease free survival rates for patients with 18-months longitudinal undetectable MRD
Time frame: 2 year
Two-years event-free survival rates for enrolled patients in two years
Time frame: 2 year
Two-years disease free survival rates for patients who tested positive for MRD and failed screening during the two-round MRD tests.
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 35543554Zhang 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.
- Derived from this study: PubMed 42266691Huang 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.
- Derived from this study: PubMed 37880076Zhang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Long Wu, M.D (020-83827812, syylwu@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-years disease free survival rates for patients with longitudinal undetectable MRD (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05457049, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.