Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma

(PRECISION-NEC Trial)

Overseen by Charles Kunos, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Charles Kunos

No Placebo Group

Trial Summary

What is the purpose of this trial?

PRECISION-NEC is a single-center, open-label, pilot feasibility study of molecularly defined subtypes of metastatic high-grade neuroendocrine carcinoma (HG-NEC). The hypothesis is that HG-NEC (excluding small cell carcinoma) can be segregated based on mutational analysis and that next generation sequencing (NGS)-based assignment of therapy is feasible and will potentially improve the outcomes.

Research Team

Charles Kunos, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

Inclusion Criteria

Histologically confirmed high grade neuroendocrine carcinoma that is metastatic and/or not resectable

Adequate tissue available for genomic sequencing

ECOG status less than or equal to 2

Treatment Details

Interventions

• Treatment for Small Cell Lung Cancer (Other)
• Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma (Other)

Participant Groups

Group I: TP53/Rb1 Co-Mutation Present Experimental Treatment 1 Intervention

HG-LCNEC tumor with the TP53/Rb1 co-mutation.

Group II: No TP53/Rb1 Co-Mutation Active Control 1 Intervention

HG-LCNEC tumor lacking the TP53/Rb1 co-mutation (non-small cell-like).

Who Is Running the Clinical Trial?

Charles Kunos

Lead Sponsor

Trials

2

Recruited

30+

Aman Chauhan

Lead Sponsor

Trials

3

Recruited

40+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Dominique C. Pichard

National Center for Advancing Translational Sciences (NCATS)

Chief Medical Officer since 2023

MD

Joni L. Rutter

National Center for Advancing Translational Sciences (NCATS)

Chief Executive Officer since 2022

PhD in Pharmacology