Non-small Cell Lung Cancer Metastatic Clinical Trial
— PRELUCAOfficial title:
Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer - a Randomized Interventional Study
NCT number | NCT05889247 |
Other study ID # | SJ-1011 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 28, 2023 |
Est. completion date | June 2032 |
Verified date | July 2023 |
Source | Zealand University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | June 2032 |
Est. primary completion date | June 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Oncology | Aalborg | |
Denmark | Department of Clinical Oncology and Palliative Care | Naestved | Zealand |
Denmark | Department of Oncology | Vejle |
Lead Sponsor | Collaborator |
---|---|
Zealand University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Overall Survival | through study completion, an average of 3 years | |
Secondary | Physicians Global Assessment to measure quality of life | Physicians Global Assessment to measure quality of life | through study completion, an average of 3 years | |
Secondary | Common Terminology Criteria for Adverse Events | Common Terminology Criteria for Adverse Events | through study completion, an average of 3 years |
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