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Brief Title: Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
Official Title: Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
Study ID: NCT03512847
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Oncology, Naestved, Zealand, Denmark
Name: Frank S Malene, MD
Affiliation: Region Zeland
Role: PRINCIPAL_INVESTIGATOR