Metastatic Nonsmall Cell Lung Cancer
Conditions
Keywords
liquid biopsy, genomic profiling, ctDNA
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.
Interventions
None listed
Sponsors
Zealand University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Other active cancers * Contraindications for systemic therapy * ALK-positive, ROS-1 or EGFR mutations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed