Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma (PRECISION-NEC)
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|ClinicalTrials.gov Identifier: NCT04452292|
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Large-Cell Neuroendocrine Carcinoma||Other: Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma Other: Treatment for Small Cell Lung Cancer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Feasibility Study of Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
Active Comparator: No TP53/Rb1 Co-Mutation
HG-LCNEC tumor lacking the TP53/Rb1 co-mutation (non-small cell-like).
Other: Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma
Treatment assigned to targetable mutation. Or, for tumors that are by and large without any targetable mutation follow NCCN guideline-directed best front-line treatment for specific non-small cell carcinoma/adenocarcinoma.
Experimental: TP53/Rb1 Co-Mutation Present
HG-LCNEC tumor with the TP53/Rb1 co-mutation.
Other: Treatment for Small Cell Lung Cancer
Treatment assigned to a targetable mutation or the current standard-of-care regimen for the treatment of small cell lung cancer.
- Sequencing Rate (Feasibility) [ Time Frame: 2 months ]Percentage of patients able to be sequenced within 2 months of the initial medical oncology visit.
- Molecular Cohort Assignment (Feasibility) [ Time Frame: 2 months ]Percentage of patients who were successfully assigned into a molecularly-definted cohort (TP53/RB1 co-mutations or not).
- Progression-Free Survival (PFS) [ Time Frame: 2 years ]Duration of time from the first cycle of anticancer therapy to time of progressive disease or death from any cause, whichever occurs first.
- Complete Response Rate [ Time Frame: 2 years ]Percentage of patients experiencing overall complete response (CR).
- Partial Response Rate [ Time Frame: 2 years ]Percentage of patients experiencing overall partial response (PR).
- Progressive Disease Rate [ Time Frame: 2 years ]Percentage of patients experiencing overall progressive disease (PD).
- Stable Disease Rate [ Time Frame: 2 years ]Percentage of patients experiencing overall stable disease (SD).
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): NCT04452292
|Contact: Aman Chauhan, MDemail@example.com|
|United States, Kentucky|
|Markey Cancer Center, University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Aman Chauhan, MD||University of Kentucky|