N/A N=2 Treatment

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

Large-Cell Neuroendocrine Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT04452292 ↗

Enrolled (actual)

Serious AEs

—

Results posted

May 2023

Primary outcome: Primary: Sequencing Rate (Feasibility)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma (Other); Treatment for Small Cell Lung Cancer (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Charles Kunos
Primary completion: May 2022

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	—	—

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.

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

View full record on ClinicalTrials.gov →

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.