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


Active: Yes
Cancer Type: NCT ID: NCT07544654
Trial Phases: Phase III Protocol IDs: 1438-0011 (primary)
NCI-2026-05224
2025-523869-22
2025-523869-22-00
U1111-1328-6623
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Boehringer Ingelheim Pharmaceuticals Inc
NCI Full Details: http://clinicaltrials.gov/show/NCT07544654

Summary

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.