NCT04452292

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 14, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2023

Completed
2 months until next milestone

Results Posted

Study results publicly available

May 17, 2023

Completed
Last Updated

May 17, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

June 24, 2020

Results QC Date

April 21, 2023

Last Update Submit

April 21, 2023

Conditions

Large-Cell Neuroendocrine Carcinoma

Keywords

poorly differentiated neuroendocrine carcinomaNGSTP53/Rb1co-mutationmolecular subtype

Outcome Measures

Primary Outcomes (2)

  • Sequencing Rate (Feasibility)

    Percentage of patients able to be sequenced within 2 months of the initial medical oncology visit.

    2 months

  • Molecular Cohort Assignment (Feasibility)

    Percentage of patients who were successfully assigned into a molecularly-defined cohort (TP53/RB1 co-mutations or not).

    2 months

Secondary Outcomes (5)

  • Progression-Free Survival (PFS)

    2 years

  • Complete Response Rate

    2 years

  • Partial Response Rate

    2 years

  • Progressive Disease Rate

    2 years

  • Stable Disease Rate

    2 years

Study Arms (2)

No TP53/Rb1 Co-Mutation

ACTIVE COMPARATOR

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

Other: Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma

TP53/Rb1 Co-Mutation Present

EXPERIMENTAL

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

Other: Treatment for Small Cell Lung Cancer

Interventions

Treatment Specific for Non-Small Cell Carcinoma/AdenocarcinomaOTHER

Treatment assigned to targetable mutation. Or, for tumors that are by and large without any targetable mutation follow Large-Cell Neuroendocrine Carcinoma (NCCN) guideline-directed best front-line treatment for specific non-small cell carcinoma/adenocarcinoma.

No TP53/Rb1 Co-Mutation
Treatment for Small Cell Lung CancerOTHER

Treatment assigned to a targetable mutation or the current standard-of-care regimen for the treatment of small cell lung cancer.

TP53/Rb1 Co-Mutation Present

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

  • Saghaeiannejad 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: 34141612DERIVED

MeSH Terms

Interventions

Therapeutics

Results Point of Contact

Title
Dr. Charles Kunos
Organization
University of Kentucky
charles.kunos@uky.edu
859-323-2354

Study Officials

  • Charles Kunos, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 30, 2020

Study Start

September 14, 2021

Primary Completion

May 4, 2022

Study Completion

March 14, 2023

Last Updated

May 17, 2023

Results First Posted

May 17, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)