Monitoring treatment in advanced lung cancer using liquid biopsy
Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer - a Randomized Interventional Study
NA · Zealand University Hospital · NCT05889247
This study is testing if a blood test can help doctors better track treatment progress in people with advanced lung cancer who are receiving immunotherapy, compared to regular scans.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Sex | All |
| Sponsor | Zealand University Hospital (other) |
| Drugs / interventions | immunotherapy |
| Locations | 5 sites (Hillerød, Region H and 4 other locations) |
| Trial ID | NCT05889247 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of liquid biopsy to monitor treatment in patients with advanced non-small cell lung cancer (NSCLC) receiving immunotherapy. It aims to optimize treatment monitoring by reducing ineffective treatments and minimizing unnecessary toxicity. The study will compare the clinical utility of circulating tumor DNA (ctDNA) measurements against traditional radiologic scans, which can be imprecise and challenging to interpret, especially after immunotherapy. By employing a randomized interventional multicenter approach, the study seeks to establish the cost-effectiveness and utility of liquid biopsy in everyday clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with newly diagnosed, histologically verified advanced non-small cell lung cancer who are eligible for first-line immunotherapy.
Not a fit: Patients with targetable alterations in EGFR, ALK, or ROS-1 or those with other active cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment monitoring and improved outcomes for patients with advanced lung cancer.
How similar studies have performed: Previous studies have shown promising results with liquid biopsy approaches, indicating potential success for this novel methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed, histologically verified, Non-Small Cell Lung Cancer (NSCLC) * Advanced or locally advanced disease without curative intended treatment options * Age \> 18 years * Eastern Cooperative Oncology Group (ECOG) score of Performance Status (PS) 0-1 * Measurable disease according to the iRECIST criteria version 1.1. * Eligible to first line immunotherapy (monotherapy) * Signed informed consent Exclusion Criteria: * Targetable alterations in EGFR, ALK or ROS-1 * Other active cancers
Where this trial is running
Hillerød, Region H and 4 other locations
- Department of Clinical Oncology — Hillerød, Region H, Denmark (RECRUITING)
- Department of Clinical Oncology and Palliative Care — Næstved, Region Sjælland, Denmark (RECRUITING)
- Department of Clinical Oncology and Palliative Care — Roskilde, Region Sjælland, Denmark (RECRUITING)
- Department of Oncology — Aalborg, Denmark (NOT_YET_RECRUITING)
- Department of Oncology — Vejle, Denmark (NOT_YET_RECRUITING)
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: Non-small Cell Lung Cancer Metastatic, liquid biopsy, treatment monitoring