Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
- Conditions
- Metastatic Nonsmall Cell Lung Cancer
- Registration Number
- NCT03512847
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
The study aims include:
* Exploring potential predictive molecular profiles to immunotherapy/chemotherapy
* Investigating the role of circulating tumor DNA as a dynamic biomarker during immunotherapy/chemotherapy
* Identifying possible resistance mechanisms to immunotherapy/chemotherapy
Materials and methods:
Approximately 150 patients diagnosed with metastatic NSCLC assigned for immunotherapy or chemotherapy will be candidates for inclusion during a 1-2 years period.
A comprehensive molecular profiling will be made from the diagnostic biopsy. Before every treatment-cycle a blood sample will be taken to quantify ctDNA. At time of progressive disease during/after first line treatment, patients will be asked to participate in a new biopsy and a comprehensive molecular profiling will be performed.
The tissue and blood samples collected will be stored in a biobank. Clinical data will be collected to perform a comprehensive database.
Analysis:
Potentially predictive molecular profiles for immunotherapy/chemotherapy will be found by comparison of treatment outcome for patients with specific molecular characteristics.
Through quantification of ctDNA during treatment and upon progression, the role of ctDNA as a dynamic biomarker will be further strengthened.
Differences in molecular profiles pre- and post-treatment may reveal resistance mechanisms to treatment. Molecular profiling on progression can be valuable in second-line treatment guidance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Age > 18 years
- Able to understand and read Danish
- WHO Performance status 0-2
- Acceptable organ function (liver/kidney/heart) for treatment
- The disease has to be:
evaluable or measurable according to RECIST/iRECIST accessible for biopsy metastatic or not suitable for curative intended treatment
- Other active cancers
- Contraindications for systemic therapy
- ALK-positive, ROS-1 or EGFR mutations
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Predictive gene profiles until progression or death, an average of 3 years Concordance between specific gene profiles and treatment outcomes
Resistance mechanisms toward chemotherapy and immunotherapy until progression or death, an average of 3 years Differences in molecular profiles pre- and post-treatment
ctDNA as a dynamic biomarker until progression or death, an average of 3 years Quantification of ctDNA during treatment linked to treatment outcome
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Oncology
🇩🇰Naestved, Zealand, Denmark