Clinical trial · Observational
Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Molecular residual disease test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Undetectable MRD
- description
- 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.
- interventionNames
- Diagnostic Test: Molecular residual disease test
Primary outcomes (1)
- measure
- Two-years disease free survival rates for patients with longitudinal undetectable MRD
- timeFrame
- 2 year
- description
- The 2-year DFS rate of patients who maintain 2-years undetectable MRD.
Secondary outcomes (5)
- measure
- Two-years disease free survival rates for patients with six months longitudinal undetectable MRD
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.).
References
Publications (3)
- BACKGROUNDZhang 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
- DERIVEDHuang 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. PMID 42266691
- DERIVEDZhang 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