DAREON®-NEC-1: Obrixtamig Plus Chemotherapy vs Standard Chemotherapy in Advanced epNEC

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

IDENTIFIER (ClinicalTrials.gov): NCT07544654

DRUG/TREATMENT: Obrixtamig, Carboplatin, Etoposide

PHASE: 3

STATUS: Recruiting

SPONSOR: Boehringer Ingelheim

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 (outside of the lungs) Neuroendocrine Carcinomas 

DESCRIPTION:

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.

For more information on eligibility criteria, trial locations, and study details, go to ClinicalTrials.gov to view this trial here.

CONTACT

Name: Boehringer Ingelheim

Phone Number: 1-800-243-0127

Email: unitedstates@bitrialsupport.com

This is a multicenter trial with various locations. Go to the “Contacts and Locations” section of this trial page at ClinicalTrials.gov for site-specific contact information.