DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy

ClinicalTrials.gov ID: NCT07544654

Public ClinicalTrials.gov record NCT07544654. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 7:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3). Participants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein. During the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.

Study identification

NCT ID: NCT07544654
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Boehringer Ingelheim; Industry
Enrollment: 390 participants

Conditions and interventions

Conditions

Extrapulmonary Neuroendocrine Cancer (epNEC)

Interventions

Drug · Device

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 9, 2026
Primary completion: Dec 12, 2029
Completion: Mar 10, 2031
Last update posted: Sep 1, 2026

2026 – 2031

United States locations

U.S. sites: 20
U.S. states: 15
U.S. cities: 19

Facility	City	State	ZIP	Site status
Mayo Clinic	Scottsdale	Arizona	85259	Not yet recruiting
City of Hope-Duarte-56419	Duarte	California	91010	Recruiting
University of California San Francisco	San Francisco	California	94158	Not yet recruiting
University of California Los Angeles	Santa Monica	California	90404	Not yet recruiting
Mayo Clinic - Florida	Jacksonville	Florida	32224	Not yet recruiting
Emory University	Atlanta	Georgia	30322	Recruiting
The University of Chicago Medical Center	Chicago	Illinois	60637	Not yet recruiting
The Skip Viragh Outpatient Cancer Research Building	Baltimore	Maryland	21287	Not yet recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Not yet recruiting
Mayo Clinic, Rochester	Rochester	Minnesota	55905	Not yet recruiting
Washington University School of Medicine	St Louis	Missouri	63108	Recruiting
Memorial Sloan-Kettering Cancer Center	New York	New York	10022	Not yet recruiting
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	15232	Not yet recruiting
University of Tennessee	Knoxville	Tennessee	37920	Recruiting
SCRI Oncology Partners	Nashville	Tennessee	37203	Not yet recruiting
Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	37232	Not yet recruiting
Baylor University Medical Center	Dallas	Texas	75246	Not yet recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Not yet recruiting
Huntsman Cancer Institute	Salt Lake City	Utah	84112	Not yet recruiting
Fred Hutchinson Cancer Research Center	Seattle	Washington	98109	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 147 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07544654, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 1, 2026 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07544654 live on ClinicalTrials.gov.

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