A Study of Obrixtamig for Advanced Extrapulmonary Neuroendocrine Cancer

This study is for adults with advanced extrapulmonary neuroendocrine cancer (epNEC), a type of cancer that starts outside the lungs. Researchers want to see if adding obrixtamig to standard chemotherapy (carboplatin and etoposide) helps people live longer compared to receiving standard chemotherapy alone. Obrixtamig is a molecule that might help your immune system fight cancer. The study also aims to test a device that measures a tumor marker called delta-like ligand 3 (DLL3). To join, you must have advanced epNEC that is poorly differentiated and has a high Ki-67 or mitotic rate. The study plans to enroll 390 participants. The main goal is to measure overall survival for up to 38 months.

Study design
This study will randomly assign participants into two groups, meaning by chance. One group will receive obrixtamig plus standard chemotherapy, and the other will receive standard chemotherapy alone.
What's involved
One group of participants will receive obrixtamig and standard chemotherapy, followed by obrixtamig alone for up to 3 years.
Compensation
Not stated in the trial record.
Follow-up
Overall survival will be measured for up to 38 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07544654

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Boehringer Ingelheim
~390 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:ObrixtamigCarboplatinEtoposideVentana DLL3 RxDx assay

At a glance

Recruiting sites
38 of 167 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over Up to 38 months
Extrapulmonary Neuroendocrine Cancer (epNEC)
167 sites across 46 states
China23
Germany13
Japan13
Spain10
France8
Italy8
Brazil5
Mexico5

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  • Overall survival (OS)Up to 38 months

    defined as the time from randomisation until death from any cause