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.
Study Type
OBSERVATIONAL
Enrollment
150
Department of Oncology
Næstved, Region Sjælland, Denmark
Predictive gene profiles
Concordance between specific gene profiles and treatment outcomes
Time frame: until progression or death, an average of 3 years
Resistance mechanisms toward chemotherapy and immunotherapy
Differences in molecular profiles pre- and post-treatment
Time frame: until progression or death, an average of 3 years
ctDNA as a dynamic biomarker
Quantification of ctDNA during treatment linked to treatment outcome
Time frame: until progression or death, an average of 3 years
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