Clinical trial · Interventional
Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma
A Pilot Feasibility Study of Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Large-Cell Neuroendocrine Carcinoma | Large Cell Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment for Small Cell Lung Cancer | Other | — | UNRESOLVED |
| Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- No TP53/Rb1 Co-Mutation
- description
- HG-LCNEC tumor lacking the TP53/Rb1 co-mutation (non-small cell-like).
- interventionNames
- Other: Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma
- type
- EXPERIMENTAL
- label
- TP53/Rb1 Co-Mutation Present
- description
- HG-LCNEC tumor with the TP53/Rb1 co-mutation.
- interventionNames
- Other: Treatment for Small Cell Lung Cancer
Primary outcomes (2)
- measure
- Sequencing Rate (Feasibility)
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSaghaeiannejad Esfahani H, Vela CM, Chauhan A. Prevalence of TP-53/Rb-1 Co-Mutation in Large Cell Neuroendocrine Carcinoma. Front Oncol. 2021 May 31;11:653153. doi: 10.3389/fonc.2021.653153. eCollection 2021. PMID 34141612