Actively Recruiting
Led by Zealand University Hospital · Updated on 2026-01-09
350
Participants Needed
5
Research Sites
261 weeks
Total Duration
Researchers are evaluating the use of liquid biopsy monitoring through circulating tumor DNA (ctDNA) in patients with advanced non-small cell lung cancer (NSCLC) who are receiving immunotherapy. This study aims to improve treatment monitoring by reducing ineffective treatments and unnecessary side effects, while also exploring the cost-effectiveness of incorporating liquid biopsy into routine care. It is a prospective randomized interventional study involving multiple clinical oncology departments and led by Zealand University Hospital. Participants are assigned to one of two groups: one group will have their treatment monitored using longitudinal ctDNA measurements along with Quality of Life assessments, while the other group will receive standard monitoring through regular CT scans and Quality of Life assessments. In the ctDNA group, treatment may be discontinued earlier than the usual two-year immunotherapy duration if a complete molecular response is detected in plasma, potentially shortening treatment periods for some patients. During the study, patients will undergo regular evaluations that include quality of life assessments, monitoring for adverse events, and tracking the number of treatments received until disease progression. The main outcome measured is overall survival over an average follow-up of three years. Secondary outcomes include physician assessments of quality of life, adverse event recording, treatment frequency, and health cost-utility analysis. The total participation time is approximately three years, during which researchers will assess the clinical benefit and economic impact of ctDNA-guided treatment monitoring.
CONDITIONS
Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years of immunotherapy or until treatment discontinuation based on monitoring results
Participants receive first line immunotherapy monitored by either circulating tumor DNA measurements or CT scans, with assessments of treatment efficacy and quality of life.
Regular visits for treatment and monitoring during immunotherapy
Duration - Up to 3 years from study enrollment
Participants are followed for overall survival and long-term outcomes after treatment completion or discontinuation.
Periodic visits for survival and health assessments
Total: 5 locations
1
Department of Clinical Oncology
Hillerød, Region H, Denmark
Actively Recruiting
2
Department of Clinical Oncology and Palliative Care
Næstved, Region Sjælland, Denmark
Actively Recruiting
3
Department of Clinical Oncology and Palliative Care
Roskilde, Region Sjælland, Denmark
Actively Recruiting
4
Department of Oncology
Aalborg, Denmark
Not Yet Recruiting
5
Department of Oncology
Vejle, Denmark
Not Yet Recruiting
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Michael Elmkvist Andersen, Christa Haugaard Nyhus, Weronika Maria Szejniuk...
https://pubmed.ncbi.nlm.nih.gov/41628935