Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorZealand University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Targetable alterations in EGFR, ALK or ROS-1
Other active cancers
Trial design
Design model
Parallel
Treatments tested in this trial
Circulating tumor DNA treatment monitoring
Other interventionA comparison of treatment monitoring by circulating tumor DNA and CT scans (standard) in patients with newly diagnosed advanced Non-Small Cell Lung Cancer (NSCLC)
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: ctDNA monitoringExperimental treatment 1 intervention
Group B: CT scan monitoringNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Overall Survival
Overall Survival
Time frame
through study completion, an average of 3 yearsSecondary outcomes
1
Physicians Global Assessment to measure quality of life
Physicians Global Assessment to measure quality of life
Time frame
through study completion, an average of 3 years2
Common Terminology Criteria for Adverse Events
Common Terminology Criteria for Adverse Events
Time frame
through study completion, an average of 3 years3
Number of Treatments
Number of treatments given and not given
Time frame
From randomization to first detection of progressive disease, an average of 3 years4
Health Cost/Utility
A health cost and utility analysis of patients in both arms
Time frame
From randomization to first detection of progressive disease, an average of 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov