Phase III Study Comparing Obrixtamig with Carboplatin and Etoposide Versus Standard Chemotherapy in Adults with DLL3-Positive Advanced Extrapulmonary Neuroendocrine Cancer

What this Trial Is About

Researchers are studying adults with advanced extrapulmonary neuroendocrine cancer to find out if adding a study medicine called obrixtamig to standard chemotherapy carboplatin and etoposide improves survival compared to standard chemotherapy alone. This phase III trial also evaluates a medical device designed to measure levels of the tumor marker DLL3, which helps identify suitable patients for treatment. Participants are randomly assigned to one of two groups. One group receives obrixtamig combined with standard chemotherapy followed by obrixtamig alone for up to three years. The other group receives just the standard chemotherapy for about four months. All treatments are given through intravenous infusions. Participants in the obrixtamig group stay overnight at the study site after the first two treatments. During the trial, participants visit the study site regularly for health checks, monitoring of any side effects, and tumor size assessments. Researchers compare outcomes such as overall survival and disease progression between the two groups. The study measures physical functioning and tracks adverse events throughout treatment, with monitoring continuing for up to 38 months.

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