Non-Small Cell Lung CancerLUNG-MRDetectNCT07921888
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
An observational study of Non-Small Cell Lung Cancer and Minimal Residual Disease, run by Eun Hye Lee at 3 sites in South Korea.
Trial summary
This is a multicenter, prospective, observational pilot cohort study in patients with surgically resected non-small cell lung cancer (NSCLC, pathologic stage IA3-IIIA). Whole exome sequencing (WES) of each patient's resected tumor tissue and matched normal blood (buffy coat) is used to build a patient-specific… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Minimal Residual Disease
- What is being tested?
- Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA) and Bronchoscopy with bronchial washing for reserach
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 28 Sep 2026to 31 Dec 2031
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (aged 19 years or older) who underwent curative-intent (R0) surgical resection for pathologically confirmed non-small cell lung cancer (NSCLC) with a final pathologic stage of IA3 to IIIA, and who are followed at three tertiary referral hospitals in Korea (Severance Hospital, Gangnam Severance Hospital, and Yongin Severance Hospital). Eligible patients are identified through outpatient and inpatient medical record review and enrolled within 1 month after surgery. A total of 40 participants will be enrolled competitively across the three sites over 2 years.
Who may be able to join
- Adults aged 19 years or older
- Pathologically confirmed non-small cell lung cancer who underwent curative-intent complete (R0) surgical resection
- Final pathologic stage IA3 (tumor size >2 cm) to IIIA after surgery
- Able to attend the first outpatient visit within 1 month after surgery, and agrees to research blood sampling, provision of surgical tissue slides, and long-term follow-up
- Provided voluntary written informed consent after adequate explanation of the study purpose and methods
Who cannot join
- Pathologic stage IA1 or IA2 (tumor size ≤2 cm), stage IV, or confirmed distant metastasis
- Incomplete resection (non-R0) or clear residual tumor after surgery
- History of other malignancy, including synchronous malignancy in another organ, that may confound interpretation of MRD results (cancers judged cured for more than 5 years may be included)
- Poor performance status or other conditions making repeated blood sampling or bronchoscopy difficult
- Unstable cardiopulmonary function, or high risk with sedation or additional procedures, in the judgment of the treating physician
- Unable to provide informed consent, or judged unable to comply with regular follow-up during the study period
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Not yet recruiting
Severance Hospital
Seoul, 03722
YONG Seunghyun, Ph.D.Course of Medical Science, +82-10-6366-0213, roneirire@yuhs.ac
SHIN Seonhye, Bachelor Degree, Nursing, +82-10-7767-3489, fresh@yuhs.ac
- Not yet recruiting
Gangnam Severance Hospital
Seoul, 06229
KIM Chiyoung, Ph.D.Course of Medical Science, +82-10-4182-1095, cykim@yuhs.ac
SHIN Seonhye, Bachelor Degree, Nursing, +82-10-7767-3489, fresh@yuhs.ac
- Recruiting
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, 16995
LEE Eunhye, Ph.D.Course of Medical Science, +82-10-4099-3780, hieunhye@yuhs.ac
SHIN Seonhye, Bachelor Degree, Nursing, +82-10-7767-3489, fresh@yuhs.ac
About this study
Official title: Development of a Patient-Specific MRD Liquid Biopsy Platform in Resected NSCLC: Combined Analysis of Plasma and Bronchial Washing ctDNA
This is a multicenter, prospective, observational pilot cohort study in patients with surgically resected non-small cell lung cancer (NSCLC, pathologic stage IA3-IIIA). Whole exome sequencing (WES) of each patient's resected tumor tissue and matched normal blood (buffy coat) is used to build a patient-specific (tumor-informed) minimal residual disease (MRD) panel, after excluding germline and clonal hematopoiesis variants. MRD is then assessed in paired plasma circulating tumor DNA (ctDNA) and bronchial washing fluid (BWF) ctDNA collected at 6, 12, 18 and 24 months after surgery. The study evaluates whether MRD positivity in plasma and/or BWF is associated with subsequent clinical or radiologic recurrence, compares MRD detection rates and quantitative values between plasma and BWF, and explores the lead time of MRD detection relative to standard surveillance with chest CT and serum CEA. MRD results are not used to confirm recurrence or to change treatment; all clinical decisions follow standard of care. Forty participants will be enrolled at three Severance hospitals in Korea.
Read the detailed description
Background. Postoperative recurrence is frequent in resected early-stage and locally advanced NSCLC (stage I-IIIA), most often within 2-3 years after surgery. Standard surveillance relies on chest CT and serum tumor markers such as CEA, which cannot detect molecular recurrence at the MRD stage before it appears on imaging. ctDNA-based MRD assessment is being actively investigated in several solid tumors. In early-stage lung cancer, however, plasma ctDNA levels after surgery are very low, which may limit detection sensitivity. Bronchial washing fluid reflects the local tumor environment of the lung, and prior studies suggest it may detect tumor-derived mutations with higher sensitivity than plasma. This study builds a patient-specific, tumor-informed MRD panel for each participant, instead of relying on a fixed generic gene panel, and evaluates plasma and BWF MRD in parallel.
Hypotheses. (1) A patient-specific MRD panel built from resected tumor tissue and normal control specimens can detect postoperative recurrence earlier than conventional imaging-based diagnosis. (2) BWF ctDNA, which reflects the local tumor environment, may show higher MRD detection sensitivity than plasma ctDNA.
Objectives. The primary objective is to evaluate whether MRD positivity in plasma and BWF is associated with subsequent clinical or radiologic recurrence in resected NSCLC. The secondary objectives are (a) to compare MRD detection rates and quantitative values between plasma and BWF and determine which specimen is more sensitive for detecting recurrence, and (b) to explore the lead time of MRD detection relative to recurrence confirmation and compare it with CT and CEA.
Design and procedures. At baseline (first outpatient visit within 1 month after surgery), unstained (10) and stained (1) slides of the surgical pathology specimen are obtained, together with blood for normal control and cfDNA. WES is performed on tumor tissue and buffy coat, and a patient-specific mutation panel is designed. At 6, 12, 18 and 24 months after surgery, 20 mL of blood and 20 mL of BWF (collected by bronchoscopy from the lobe or segment of the original lesion, using saline) are obtained for MRD analysis. Additional blood/BWF MRD assessments may be performed at unscheduled visits when recurrence is clinically suspected. MRD follow-up ends at 24 months, recurrence or death. After 24 months, participants are followed under standard practice (CT and CEA every 3 months) without additional MRD testing. All specimens are shipped under anonymized serial codes to an external laboratory (IMBDx) for analysis and are handled according to the participant's consent regarding retention and secondary use.
Statistical analysis. The main analysis set includes enrolled participants whose patient-specific panel was successfully built and who have at least one evaluable postoperative MRD result. Recurrence-free survival (RFS) of MRD-positive and MRD-negative groups is estimated by the Kaplan-Meier method and compared with the log-rank test. Hazard ratios with 95% confidence intervals are estimated by Cox regression as exploratory analyses. Paired plasma-BWF detection rates are compared with McNemar's test, and paired quantitative values (variant allele frequency) with the paired t-test or Wilcoxon signed-rank test. Sensitivity, specificity, PPV, NPV, ROC curve and AUC are computed exploratorily. Lead time is summarized descriptively. Missing data are not imputed. Because this is a pilot study of 40 participants, results are interpreted by effect sizes and confidence intervals rather than formal significance testing.
Safety and monitoring. MRD results are not used alone to confirm recurrence or change adjuvant therapy. Adverse events related to blood sampling and bronchoscopy are recorded. An independent safety monitor, who is not a member of the study team, will perform two monitoring visits. Serious adverse events are reported according to each institution's IRB requirements. Data from all sites are de-identified, coded, and managed centrally.
- Being tested
- Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA), Bronchoscopy with bronchial washing for reserach
- Keywords
- ctDNA, circulating tumor DNA, bronchial washing fluid, tumor-informed MRD, liquid biopsy, whole exome sequencing, postoperative recurrence, resected NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA)Diagnostic test
WES of surgical tumor tissue and matched normal blood to design a patient-specific mutation panel, followed by MRD detection in plasma ctDNA and BWF ctDNA at 6, 12, 18 and 24 months after surgery and at unscheduled visits if recurrence is suspected. Results are not used for treatment decisions.
Bronchoscopy with bronchial washing for reserachProcedure or surgery
Bronchoscopy performed by the treating pulmonologist, with 20 mL saline bronchial washing from the lobe or segment of the original tumor, at 6, 12, 18 and 24 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Resected NSCLC (stage IA3-IIIA) | Adults who underwent curative-intent (R0) resection for pathologic stage IA3-IIIA NSCLC. Participants undergo patient-specific MRD panel construction and serial plasma and BWF MRD testing at 6, 12, 18 and 24 months after surgery. Receives: Diagnostic Test: Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA); Procedure: Bronchoscopy with bronchial washing for reserach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS) according to MRD status in plasma and/or BWF ctDNA
RFS of MRD-positive versus MRD-negative participants, defined as the time from surgery to first clinical or radiologic recurrence (or death, if applicable). Estimated by the Kaplan-Meier method and compared with the log-rank test. Hazard ratio with 95% confidence interval estimated exploratorily by Cox regression.
Measured: Up to 24 months after surgery
Secondary outcomes (4)
MRD detection rate in plasma ctDNA versus BWF ctDNA
Proportion of MRD-positive results in paired plasma and BWF samples collected at the same time point, compared with McNemar's test.
Measured: 6, 12, 18 and 24 months after surgery
Quantitative MRD value (variant allele frequency) in plasma versus BWF
ariant allele frequency of patient-specific variants in paired plasma and BWF samples, compared with the paired t-test or Wilcoxon signed-rank test.
Measured: 6, 12, 18 and 24 months after surgery
Diagnostic performance of MRD for recurrence
Sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve (AUC) of plasma and BWF MRD for detecting recurrence, evaluated exploratorily and compared descriptively with CT and CEA.
Measured: Up to 24 months after surgery
Lead time of MRD positivity before recurrence confirmation
Interval (months) from first MRD positivity to recurrence confirmed by CT or clinical diagnosis, summarized as mean ± SD or median (IQR), range, and 95% confidence interval, and compared with CT and CEA.
Measured: Up to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start28 Sep 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eun Hye Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Gangnam Severance Hospital
- Responsible party
- Sponsor-investigator, Eun Hye Lee, Yonsei University
- Investigators
- LEE Eunhye, Ph.D.Course of Medical Science, Principal investigator, Division of Pulmonology, Allergy and Critical Care Medicine, Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921888
- Sponsor's protocol ID
- 9-2026-0153
- Acronym
- LUNG-MRDetect
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be de-identified and managed centrally; individual participant data are not planned to be shared at this time.
Publications
Ohara S, Suda K, Sudhaman S, Hamada A, Chiba M, Shimoji M, Takemoto T, Kalashnikova E, Cheung SK, Krainock M, Feeney J, Sethi H, Liu MC, Soh J, Tsutani Y, Mitsudomi T. Clinical Significance of Perioperative Minimal Residual Disease Detected by Circulating Tumor DNA in Patients With Lung Cancer With a Long Follow-up Data: An Exploratory Study. JTO Clin Res Rep. 2024 Nov 12;6(3):100762. doi: 10.1016/j.jtocrr.2024.100762. eCollection 2025 Mar.
PubMed 39990137Kim MH, Kim SH, Seong H, Eom JS. Enhanced Detection of Druggable Mutations in Non-Small Cell Lung Cancer Using Targeted Collection of Bronchial Washing Fluid Compared With Plasma and Tumor Tissue. JCO Precis Oncol. 2025 Aug;9:e2500299. doi: 10.1200/PO-25-00299. Epub 2025 Aug 1.
PubMed 40749152Lee SH, Kim EY, Kim T, Chang YS. Compared to plasma, bronchial washing fluid shows higher diagnostic yields for detecting EGFR-TKI sensitizing mutations by ddPCR in lung cancer. Respir Res. 2020 Jun 9;21(1):142. doi: 10.1186/s12931-020-01408-x.
PubMed 32517757Wang Y, Shao W, Li H, Zhao P, Tian L, Zhang L, Lan S, Zhong R, Zhang S, Cheng Y. Clinical application of minimal residual disease detection by ctDNA testing in non-small cell lung cancer: a narrative review. Transl Lung Cancer Res. 2025 Mar 31;14(3):1007-1020. doi: 10.21037/tlcr-24-942. Epub 2025 Mar 27.
PubMed 40248720Lu D, Lin N, Li S, Jing Q, Yin JC, Shi L, Zhang Z, Chen Z, Wang Z, Tong Y, Zhai J, Feng S, Cai K. Predictive Effectiveness of Circulating Tumor DNA in Recurrent Early-Stage Non-Small Cell Lung Cancer: An Updated Meta-Analysis. JCO Precis Oncol. 2025 Oct;9:e2500489. doi: 10.1200/PO-25-00489. Epub 2025 Oct 9.
PubMed 41066727Kim KY, Kim HC, Kim TJ, Kim HK, Moon MH, Beck KS, Suh YG, Song CH, Ahn JS, Lee JE, Jeon JH, Jung CY, Cho JS, Choi YD, Hwang SS, Choi CM, Jang SH, Lim JU; Korean Association for Lung Cancer, Korea Central Cancer Registry. Factors Associated with Postoperative Recurrence in Stage I to IIIA Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation: Analysis of Korean National Population Data. Cancer Res Treat. 2025 Jan;57(1):83-94. doi: 10.4143/crt.2024.073. Epub 2024 Jul 10.
PubMed 38993094Ahn JH, Choi SH, Park SH, Kim I, Park JH, Kim JY, Kim TH, Lee T, Cho HK, Jeong JH, Yang JW, Park JE, Kim TH, Lee HK, Lee HY, Jung HJ, Kim J, Son J, Eom JS. Longitudinal Analysis of Recurrence and Risk Factors of Early-Stage Resected Adenocarcinoma With Common EGFR Mutations: A Multicenter Retrospective Cohort Study in South Korea. Clin Lung Cancer. 2025 Jun;26(4):314-323.e6. doi: 10.1016/j.cllc.2025.02.016. Epub 2025 Mar 7.
PubMed 40157900Rajaram R, Huang Q, Li RZ, Chandran U, Zhang Y, Amos TB, Wright GWJ, Ferko NC, Kalsekar I. Recurrence-Free Survival in Patients With Surgically Resected Non-Small Cell Lung Cancer: A Systematic Literature Review and Meta-Analysis. Chest. 2024 May;165(5):1260-1270. doi: 10.1016/j.chest.2023.11.042. Epub 2023 Dec 6.
PubMed 38065405
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Patient-Specific MRD Liquid Biopsy Platform in Resected NSCLC: Combined Analysis of Plasma and Bronchial Washing ctDNA
- ClinicalTrials.gov ID
- NCT07921888
- Acronym / sponsor ID
- LUNG-MRDetect / 9-2026-0153
- Keywords
- ctDNA, circulating tumor DNA, bronchial washing fluid, tumor-informed MRD, liquid biopsy, whole exome sequencing, postoperative recurrence, resected NSCLC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eun Hye LeeUniversity, hospital or other
- Collaborators
- Severance Hospital, Gangnam Severance Hospital
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 6 Nov 2026 (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.
This is a multicenter, prospective, observational pilot cohort study in patients with surgically resected non-small cell lung cancer (NSCLC, pathologic stage IA3-IIIA). Whole exome sequencing (WES) of each patient's resected tumor tissue and matched normal blood (buffy coat) is used to build a patient-specific (tumor-informed) minimal residual disease (MRD) panel, after excluding germline and clonal hematopoiesis variants. MRD is then assessed in paired plasma circulating tumor DNA (ctDNA) and bronchial washing fluid (BWF) ctDNA collected at 6, 12, 18 and 24 months after surgery. The study evaluates whether MRD positivity in plasma and/or BWF is associated with subsequent clinical or radiologic recurrence, compares MRD detection rates and quantitative values between plasma and BWF, and explores the lead time of MRD detection relative to standard surveillance with chest CT and serum CEA. MRD results are not used to confirm recurrence or to change treatment; all clinical decisions follow standard of care. Forty participants will be enrolled at three Severance hospitals in Korea.
Detailed description
Background. Postoperative recurrence is frequent in resected early-stage and locally advanced NSCLC (stage I-IIIA), most often within 2-3 years after surgery. Standard surveillance relies on chest CT and serum tumor markers such as CEA, which cannot detect molecular recurrence at the MRD stage before it appears on imaging. ctDNA-based MRD assessment is being actively investigated in several solid tumors. In early-stage lung cancer, however, plasma ctDNA levels after surgery are very low, which may limit detection sensitivity. Bronchial washing fluid reflects the local tumor environment of the lung, and prior studies suggest it may detect tumor-derived mutations with higher sensitivity than plasma. This study builds a patient-specific, tumor-informed MRD panel for each participant, instead of relying on a fixed generic gene panel, and evaluates plasma and BWF MRD in parallel.
Hypotheses. (1) A patient-specific MRD panel built from resected tumor tissue and normal control specimens can detect postoperative recurrence earlier than conventional imaging-based diagnosis. (2) BWF ctDNA, which reflects the local tumor environment, may show higher MRD detection sensitivity than plasma ctDNA.
Objectives. The primary objective is to evaluate whether MRD positivity in plasma and BWF is associated with subsequent clinical or radiologic recurrence in resected NSCLC. The secondary objectives are (a) to compare MRD detection rates and quantitative values between plasma and BWF and determine which specimen is more sensitive for detecting recurrence, and (b) to explore the lead time of MRD detection relative to recurrence confirmation and compare it with CT and CEA.
Design and procedures. At baseline (first outpatient visit within 1 month after surgery), unstained (10) and stained (1) slides of the surgical pathology specimen are obtained, together with blood for normal control and cfDNA. WES is performed on tumor tissue and buffy coat, and a patient-specific mutation panel is designed. At 6, 12, 18 and 24 months after surgery, 20 mL of blood and 20 mL of BWF (collected by bronchoscopy from the lobe or segment of the original lesion, using saline) are obtained for MRD analysis. Additional blood/BWF MRD assessments may be performed at unscheduled visits when recurrence is clinically suspected. MRD follow-up ends at 24 months, recurrence or death. After 24 months, participants are followed under standard practice (CT and CEA every 3 months) without additional MRD testing. All specimens are shipped under anonymized serial codes to an external laboratory (IMBDx) for analysis and are handled according to the participant's consent regarding retention and secondary use.
Statistical analysis. The main analysis set includes enrolled participants whose patient-specific panel was successfully built and who have at least one evaluable postoperative MRD result. Recurrence-free survival (RFS) of MRD-positive and MRD-negative groups is estimated by the Kaplan-Meier method and compared with the log-rank test. Hazard ratios with 95% confidence intervals are estimated by Cox regression as exploratory analyses. Paired plasma-BWF detection rates are compared with McNemar's test, and paired quantitative values (variant allele frequency) with the paired t-test or Wilcoxon signed-rank test. Sensitivity, specificity, PPV, NPV, ROC curve and AUC are computed exploratorily. Lead time is summarized descriptively. Missing data are not imputed. Because this is a pilot study of 40 participants, results are interpreted by effect sizes and confidence intervals rather than formal significance testing.
Safety and monitoring. MRD results are not used alone to confirm recurrence or change adjuvant therapy. Adverse events related to blood sampling and bronchoscopy are recorded. An independent safety monitor, who is not a member of the study team, will perform two monitoring visits. Serious adverse events are reported according to each institution's IRB requirements. Data from all sites are de-identified, coded, and managed centrally.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resected NSCLC (stage IA3-IIIA) | – | Diagnostic Test: Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA), Procedure: Bronchoscopy with bronchial washing for reserachAdults who underwent curative-intent (R0) resection for pathologic stage IA3-IIIA NSCLC. Participants undergo patient-specific MRD panel construction and serial plasma and BWF MRD testing at 6, 12, 18 and 24 months after surgery. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (aged 19 years or older) who underwent curative-intent (R0) surgical resection for pathologically confirmed non-small cell lung cancer (NSCLC) with a final pathologic stage of IA3 to IIIA, and who are followed at three tertiary referral hospitals in Korea (Severance Hospital, Gangnam Severance Hospital, and Yongin Severance Hospital). Eligible patients are identified through outpatient and inpatient medical record review and enrolled within 1 month after surgery. A total of 40 participants will be enrolled competitively across the three sites over 2 years.
Key inclusion criteria (5 listed)
- Adults aged 19 years or older
- Pathologically confirmed non-small cell lung cancer who underwent curative-intent complete (R0) surgical resection
- Final pathologic stage IA3 (tumor size >2 cm) to IIIA after surgery
- Able to attend the first outpatient visit within 1 month after surgery, and agrees to research blood sampling, provision of surgical tissue slides, and long-term follow-up
- Provided voluntary written informed consent after adequate explanation of the study purpose and methods
Key exclusion criteria (6 listed)
- Pathologic stage IA1 or IA2 (tumor size ≤2 cm), stage IV, or confirmed distant metastasis
- Incomplete resection (non-R0) or clear residual tumor after surgery
- History of other malignancy, including synchronous malignancy in another organ, that may confound interpretation of MRD results (cancers judged cured for more than 5 years may be included)
- Poor performance status or other conditions making repeated blood sampling or bronchoscopy difficult
- Unstable cardiopulmonary function, or high risk with sedation or additional procedures, in the judgment of the treating physician
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 |
|---|---|---|
| Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA)WES of surgical tumor tissue and matched normal blood to design a patient-specific mutation panel, followed by MRD detection in plasma ctDNA and BWF ctDNA at 6, 12, 18 and 24 months after surgery and at unscheduled visits if recurrence is suspected. Results are not used for treatment decisions. | Diagnostic test | Resected NSCLC (stage IA3-IIIA) |
| Bronchoscopy with bronchial washing for reserachBronchoscopy performed by the treating pulmonologist, with 20 mL saline bronchial washing from the lobe or segment of the original tumor, at 6, 12, 18 and 24 months after surgery. | Procedure or surgery | Resected NSCLC (stage IA3-IIIA) |
Primary outcome
Recurrence-free survival (RFS) according to MRD status in plasma and/or BWF ctDNA
Time frame: Up to 24 months after surgery
RFS of MRD-positive versus MRD-negative participants, defined as the time from surgery to first clinical or radiologic recurrence (or death, if applicable). Estimated by the Kaplan-Meier method and compared with the log-rank test. Hazard ratio with 95% confidence interval estimated exploratorily by Cox regression.
4 secondary outcomes
MRD detection rate in plasma ctDNA versus BWF ctDNA
Time frame: 6, 12, 18 and 24 months after surgery
Quantitative MRD value (variant allele frequency) in plasma versus BWF
Time frame: 6, 12, 18 and 24 months after surgery
Diagnostic performance of MRD for recurrence
Time frame: Up to 24 months after surgery
Lead time of MRD positivity before recurrence confirmation
Time frame: Up to 24 months after surgery
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 6 Nov 2026.
- Background: PubMed 39990137Ohara S, Suda K, Sudhaman S, Hamada A, Chiba M, Shimoji M, Takemoto T, Kalashnikova E, Cheung SK, Krainock M, Feeney J, Sethi H, Liu MC, Soh J, Tsutani Y, Mitsudomi T. Clinical Significance of Perioperative Minimal Residual Disease Detected by Circulating Tumor DNA in Patients With Lung Cancer With a Long Follow-up Data: An Exploratory Study. JTO Clin Res Rep. 2024 Nov 12;6(3):100762. doi: 10.1016/j.jtocrr.2024.100762. eCollection 2025 Mar.
- Background: PubMed 40749152Kim MH, Kim SH, Seong H, Eom JS. Enhanced Detection of Druggable Mutations in Non-Small Cell Lung Cancer Using Targeted Collection of Bronchial Washing Fluid Compared With Plasma and Tumor Tissue. JCO Precis Oncol. 2025 Aug;9:e2500299. doi: 10.1200/PO-25-00299. Epub 2025 Aug 1.
- Background: PubMed 32517757Lee SH, Kim EY, Kim T, Chang YS. Compared to plasma, bronchial washing fluid shows higher diagnostic yields for detecting EGFR-TKI sensitizing mutations by ddPCR in lung cancer. Respir Res. 2020 Jun 9;21(1):142. doi: 10.1186/s12931-020-01408-x.
- Background: PubMed 40248720Wang Y, Shao W, Li H, Zhao P, Tian L, Zhang L, Lan S, Zhong R, Zhang S, Cheng Y. Clinical application of minimal residual disease detection by ctDNA testing in non-small cell lung cancer: a narrative review. Transl Lung Cancer Res. 2025 Mar 31;14(3):1007-1020. doi: 10.21037/tlcr-24-942. Epub 2025 Mar 27.
- Background: PubMed 41066727Lu D, Lin N, Li S, Jing Q, Yin JC, Shi L, Zhang Z, Chen Z, Wang Z, Tong Y, Zhai J, Feng S, Cai K. Predictive Effectiveness of Circulating Tumor DNA in Recurrent Early-Stage Non-Small Cell Lung Cancer: An Updated Meta-Analysis. JCO Precis Oncol. 2025 Oct;9:e2500489. doi: 10.1200/PO-25-00489. Epub 2025 Oct 9.
- Background: PubMed 38993094Kim KY, Kim HC, Kim TJ, Kim HK, Moon MH, Beck KS, Suh YG, Song CH, Ahn JS, Lee JE, Jeon JH, Jung CY, Cho JS, Choi YD, Hwang SS, Choi CM, Jang SH, Lim JU; Korean Association for Lung Cancer, Korea Central Cancer Registry. Factors Associated with Postoperative Recurrence in Stage I to IIIA Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation: Analysis of Korean National Population Data. Cancer Res Treat. 2025 Jan;57(1):83-94. doi: 10.4143/crt.2024.073. Epub 2024 Jul 10.
- Background: PubMed 40157900Ahn JH, Choi SH, Park SH, Kim I, Park JH, Kim JY, Kim TH, Lee T, Cho HK, Jeong JH, Yang JW, Park JE, Kim TH, Lee HK, Lee HY, Jung HJ, Kim J, Son J, Eom JS. Longitudinal Analysis of Recurrence and Risk Factors of Early-Stage Resected Adenocarcinoma With Common EGFR Mutations: A Multicenter Retrospective Cohort Study in South Korea. Clin Lung Cancer. 2025 Jun;26(4):314-323.e6. doi: 10.1016/j.cllc.2025.02.016. Epub 2025 Mar 7.
- Background: PubMed 38065405Rajaram R, Huang Q, Li RZ, Chandran U, Zhang Y, Amos TB, Wright GWJ, Ferko NC, Kalsekar I. Recurrence-Free Survival in Patients With Surgically Resected Non-Small Cell Lung Cancer: A Systematic Literature Review and Meta-Analysis. Chest. 2024 May;165(5):1260-1270. doi: 10.1016/j.chest.2023.11.042. Epub 2023 Dec 6.
- Individual participant dataSharing planned: No. Data will be de-identified and managed centrally; individual participant data are not planned to be shared at this time.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
LEE Eunhye, Ph.D.Course of Medical Science principal investigator
Division of Pulmonology, Allergy and Critical Care Medicine, Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine
3 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 and Minimal Residual Disease, run by Eun Hye Lee at 3 sites in South Korea.
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 5 inclusion and 6 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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 LEE Eunhye, Ph.D.Course of Medical Science (+82-10-4099-3780, hieunhye@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) according to MRD status in plasma and/or BWF ctDNA (time frame: Up to 24 months after surgery). 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 NCT07921888, which also lists 8 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 6 Nov 2026.