Detecting minimal residual disease in lung cancer patients
Dynamic Monitoring of MRD in Neoadjuvant Chemoimmunotherapy for Resectable Stage II-IIIB Non-small Cell Lung Cancer：An Observational Study
The First Hospital of Jilin University · NCT06267144
This study is testing if tracking minimal residual disease in lung cancer patients receiving treatment can help predict their chances of staying cancer-free and living longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University (other) |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT06267144 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the predictive value of minimal residual disease (MRD) in patients with potentially resectable Stage IIIA-IIIB non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemoimmunotherapy. The study will focus on long-term follow-up and dynamic monitoring of MRD to assess its correlation with disease-free survival, major pathologic response, and overall survival. By identifying patients with detectable MRD, the study seeks to improve predictions of relapse and overall outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with untreated, resectable Stage II-IIIA/IIIB non-small cell lung cancer who meet specific histological and performance status criteria.
Not a fit: Patients with mixed carcinoma components, other active malignancies, or known autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict relapse and improve survival outcomes for lung cancer patients.
How similar studies have performed: Other studies have shown promise in using MRD as a predictive marker in cancer treatment, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2. * Have previously untreated and histological examination confirms resectable stage II-IIIA/IIIB non-small cell lung cancer (according to the 8th edition of the AJCC TNM staging criteria), and the pathological type of squamous cell carcinoma and non-squamous cell carcinoma needs to be distinguished, and EGFR, ALK, and ROS1 should be negative for non-squamous non-small cell lung cancer * Adequate organ function and expected survival time ≥ 12 weeks; * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Key Exclusion Criteria: * Presence of mixed carcinoma component on histology. * Patients with other active malignancies within 5 years prior to enrollment. * Known active autoimmune diseases. * Currently participate in an interventional clinical study treatment or have been treated with another drug or investigational device within 4 weeks prior to the first dose. * Use of immunosuppressive agents within 14 days prior to the first dose of study treatment. * Presence of other uncontrolled serious medical conditions.
Where this trial is running
Changchun, Jilin
- The First Hospital Of Jilin University — Changchun, Jilin, China (RECRUITING)
Study contacts
- Study coordinator: Kewei Ma
- Email: makw@jlu.edu.cn
- Phone: 0431-88782179
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.
Conditions: Lung Cancer, Neoadjuvant, Non Small Cell Lung Carcinoma