N/A
Completed N=2
Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma
Large-Cell Neuroendocrine Carcinoma
Source: ClinicalTrials.gov NCT04452292 ↗
Enrolled (actual)
2
Serious AEs
—
Results posted
May 2023
Primary outcomePrimary: Sequencing Rate (Feasibility)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sequencing Rate (Feasibility) |
— | — |
| PRIMARY Molecular Cohort Assignment (Feasibility) |
— | — |
| SECONDARY Progression-Free Survival (PFS) |
— | — |
| SECONDARY Complete Response Rate |
— | — |
| SECONDARY Partial Response Rate |
— | — |
| SECONDARY Progressive Disease Rate |
— | — |
| SECONDARY Stable Disease Rate |
— | — |
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
- Able to consent
- Patient received up to two cycles of chemotherapy prior to enrollment
- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function
Exclusion Criteria
- Small cell carcinoma
- Psychiatric illness or social situations that limit compliance
- Pregnant and nursing women
- Patients who have completed more than two cycles of chemotherapy
- Patients with resectable cancer or eligible for curative therapy
- Patients with an actionable mutation for with guidelines recommend up-front therapy with targeted agents
Data sourced from ClinicalTrials.gov (NCT04452292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.