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Study identifier: NCT07544654 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Extrapulmonary Neuroendocrine Cancer (epNEC)  ·  Sponsor: Boehringer Ingelheim

PhasePhase 3
Planned participants390
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Boehringer Ingelheim  ·  1-800-243-012  ·  clintriage.rdg@boehringer-ingelheim.com

Always discuss trial participation with your own doctor first.

Locations (165)

Mayo ClinicScottsdale, Arizona, United StatesNot Yet Recruiting
City of Hope-Duarte-56419Duarte, California, United StatesNot Yet Recruiting
Stanford Cancer CenterPalo Alto, California, United StatesNot Yet Recruiting
University of California San FranciscoSan Francisco, California, United StatesNot Yet Recruiting
University of California Los AngelesSanta Monica, California, United StatesNot Yet Recruiting
Mayo Clinic - FloridaJacksonville, Florida, United StatesNot Yet Recruiting
Emory UniversityAtlanta, Georgia, United StatesNot Yet Recruiting
The Skip Viragh Outpatient Cancer Research BuildingBaltimore, Maryland, United StatesNot Yet Recruiting
Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesNot Yet Recruiting
Mayo Clinic, RochesterRochester, Minnesota, United StatesNot Yet Recruiting
Washington University School of MedicineSt Louis, Missouri, United StatesNot Yet Recruiting
Memorial Sloan-Kettering Cancer CenterNew York, New York, United StatesNot Yet Recruiting

+ 153 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07544654