Monitoring treatment in advanced lung cancer using liquid biopsy
Official title: Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer - a Randomized Interventional Study
Run by Zealand University Hospital · NCT05889247 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Zealand University Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 5 sites (Hillerød, Region H and 4 other locations) |
| Status | Recruiting |
| Started | July 28, 2023 |
| Main results expected | June 2027 |
| Study ends | June 2032 |
| Registry record updated | January 9, 2026 |
| Trial ID | NCT05889247 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with liquid biopsy approaches, indicating potential success for this novel methodology.
Who can join: the full rules
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 it's running
-
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
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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.