Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03512847|
Recruitment Status : Active, not recruiting
First Posted : May 1, 2018
Last Update Posted : February 9, 2022
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.
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.
|Condition or disease|
|Metastatic Nonsmall Cell Lung Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer|
|Actual Study Start Date :||May 29, 2018|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2022|
- Predictive gene profiles [ Time Frame: until progression or death, an average of 3 years ]Concordance between specific gene profiles and treatment outcomes
- Resistance mechanisms toward chemotherapy and immunotherapy [ Time Frame: until progression or death, an average of 3 years ]Differences in molecular profiles pre- and post-treatment
- ctDNA as a dynamic biomarker [ Time Frame: until progression or death, an average of 3 years ]Quantification of ctDNA during treatment linked to treatment outcome
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512847
|Department of Oncology|
|Naestved, Zealand, Denmark|
|Principal Investigator:||Frank S Malene, MD||Region Zeland|