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Treatment for Small Cell Lung Cancer for Neuroendocrine Carcinoma (PRECISION-NEC Trial)

N/A

Waitlist Available

Led By Charles Kunos, MD

Research Sponsored by Charles Kunos

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

PRECISION-NEC Trial Summary

This trial is testing if molecularly defined subtypes of metastatic high-grade neuroendocrine carcinoma (HG-NEC) can be segregated and if next generation sequencing (NGS)-based assignment of therapy is feasible and will potentially improve the outcomes.

Eligible Conditions

Large Cell Neuroendocrine Carcinoma

PRECISION-NEC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Molecular Cohort Assignment (Feasibility)

Sequencing Rate (Feasibility)

Secondary outcome measures

Complete Response Rate

Partial Response Rate

Progression-Free Survival (PFS)

+2 more

PRECISION-NEC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TP53/Rb1 Co-Mutation PresentExperimental Treatment1 Intervention

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

Group II: No TP53/Rb1 Co-MutationActive Control1 Intervention

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

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Find a Location

Who is running the clinical trial?

Charles KunosLead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

National Center for Advancing Translational Sciences (NCATS)NIH

321 Previous Clinical Trials

401,747 Total Patients Enrolled

Aman ChauhanLead Sponsor

2 Previous Clinical Trials

34 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this research endeavor attempting to accomplish?

"This two-month trial aims to determine the feasibility of Molecular Cohort Assignment as its primary outcome. Secondary assessments, including Complete Response Rate, Stable Disease Rate, and Partial Response Rate will also be recorded."

Answered by AI

What is the current enrollment rate for this clinical trial?

"Affirmative. According to the online listing, this research endeavor is currently recruiting patients. It was first posted on September 14th 2021 and last revised on January 12th 2022 with a targeted enrolment of 15 participants from 1 site."

Answered by AI

Does this experiment currently require participant recruitment?

"This clinical trial is presently recruiting participants, as indicated by the information posted on clinicaltrials.gov. It was originally published on September 14th 2021 and its most recent update occurred January 12th 2022."

Answered by AI

Recent research and studies

Frontiers in OncologyJournal

Prevalence of Tp-53/rb-1 Co-mutation in Large Cell Neuroendocrine Carcinoma

Saghaeiannejad Esfahani, Hoda, Cory M. Vela, and Aman Chauhan. 2021. “Prevalence of Tp-53/rb-1 Co-mutation in Large Cell Neuroendocrine Carcinoma”. Frontiers in Oncology. Frontiers Media SA. doi:10.3389/fonc.2021.653153.

clinicaltrials.govStudy

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

Charles Kunos 2021. "Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04452292.