Omitting adjuvant therapy for lung cancer patients with undetectable molecular residual disease
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
Run by Guangdong Association of Clinical Trials · NCT05457049 · Data updated 2026-11-12
This study is testing whether lung cancer patients who have no detectable cancer signs after surgery can safely skip additional treatment and just be monitored.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Guangdong Association of Clinical Trials Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Foshan, Guangdong and 4 other locations) |
| Status | Recruiting |
| Started | August 1, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT05457049 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with stage IB-IIIA NSCLC who have undergone complete surgical resection and have confirmed undetectable MRD.
✕Probably not a fit
Patients who have received prior anti-tumor therapies or have unstable systemic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with resected non-small cell lung cancer (NSCLC) who have shown longitudinal undetectable molecular residual disease (MRD). Participants will undergo MRD testing shortly after surgery and again one month later to confirm their MRD status. Those with confirmed undetectable MRD will be monitored closely without receiving additional adjuvant therapy. The goal is to evaluate the negative predictive value of undetectable MRD as a prognostic factor in this patient population.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary adjuvant therapy in patients with favorable MRD status, minimizing treatment-related side effects.
How similar studies have gone: While the concept of monitoring MRD is gaining traction, this specific approach to omitting adjuvant therapy based on MRD status is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.).
Where it's running
-
The First People's Hospital of Foshan
Foshan, Guangdong, China Recruiting -
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China Recruiting -
Shantou Centeral Hospital
Shantou, Guangdong, China Recruiting -
the First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China Recruiting -
Zhongshan City People's Hospital
Zhongshan, Guangdong, China Recruiting
Study contacts
- Study coordinator: Yi-Long Wu, M.D
- Email: syylwu@live.cn
- Phone: 020-83827812
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.