Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer

Conditions
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Metastatic Nonsmall Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive gene profiles | Concordance between specific gene profiles and treatment outcomes | until progression or death, an average of 3 years | 
| Resistance mechanisms toward chemotherapy and immunotherapy | Differences in molecular profiles pre- and post-treatment | until progression or death, an average of 3 years | 
| ctDNA as a dynamic biomarker | Quantification of ctDNA during treatment linked to treatment outcome | until progression or death, an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liquid biopsy, genomic profiling, ctDNA