Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer
Recruiting · NCT05889247 · Interventional (participants receive a specific treatment) · Lead sponsor: Zealand University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Circulating tumor DNA treatment monitoring
What this trial is about
The study is a prospective randomized interventional study including patients with advanced non-small cell lung cancer, receiving immunotherapy, with the aim of optimizing treatment monitoring. The study aims to investigate the clinical utility of liquid biopsy monitoring in order to reduce the numbers of inefficient treatments and needless toxicity - and to explore the cost-effectiveness and cost-utility of introducing liquid biopsy monitoring in daily clinical practice.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
5 locations listed.
- Department of Oncology - Aalborg, Denmark
- Department of Oncology - Vejle, Denmark
- Department of Clinical Oncology - Hillerød, Region H, Denmark
- Department of Clinical Oncology and Palliative Care - Næstved, Region Sjælland, Denmark
- Department of Clinical Oncology and Palliative Care - Roskilde, Region Sjælland, Denmark