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

Conditions

• Extrapulmonary Neuroendocrine Cancer (epNEC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Obrixtamig — DRUG
  Obrixtamig
• Carboplatin — DRUG
  Carboplatin
• Etoposide — DRUG
  Etoposide
• Ventana DLL3 RxDx assay — DEVICE
  Ventana DLL3 RxDx assay

Study Details

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.

Key Dates

First listed

Apr 22, 2026

Start date

Jul 10, 2026

Status verified

Jul 2026

Primary completion

Dec 13, 2029

Completion

Mar 11, 2031

Study Design

Enrollment

390 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Obrixtamig + carboplatin + etoposide
  Treatment arm
• Active Comparator: Carboplatin + etoposide
  Control arm

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Up to 38 months ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-012
  [email protected]

Locations (21)

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