Omitting adjuvant therapy for lung cancer patients with undetectable molecular residual disease
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
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 |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guangdong Association of Clinical Trials Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05457049 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have received prior anti-tumor therapies or have unstable systemic diseases may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yi-Long Wu, M.D
- Email: syylwu@live.cn
- Phone: 020-83827812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.