Not yet recruitingPHASE3INTERVENTIONAL

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

This study is for adults with advanced neuroendocrine cancer that started outside the lungs. Researchers want to find out if adding a new medicine, obrixtamig, to standard chemotherapy (carboplatin and etoposide) helps people live longer compared to chemotherapy alone. Obrixtamig is a special drug that might help your body's immune system fight the cancer. The study is also testing a new way to measure a specific marker in cancer cells called DLL3. Participants are randomly put into two groups: one gets the new drug plus chemotherapy, and the other gets only chemotherapy. Doctors will regularly check participants' health and the size of their tumours.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Boehringer Ingelheim

Enrolment target

390

Start

15 Jun 2026

Estimated completion

13 Dec 2029

Extrapulmonary Neuroendocrine Cancer

What is this study about?

This clinical trial is looking for adults who have a type of advanced neuroendocrine cancer that has spread or can't be removed by surgery. This cancer specifically started outside of the lungs. The main goal of the study is to see if a new medicine called obrixtamig can improve how long patients live when added to their usual chemotherapy treatment. Obrixtamig is designed to help your body's own defence system, called the immune system, target and fight the cancer cells.

Imagine your body has an army (your immune system) and the cancer cells are invaders. Obrixtamig is like a special tool that helps your army recognise and attack these invaders more effectively. The study is comparing this new combined treatment to what is currently considered standard chemotherapy. All treatments are given directly into a vein through an infusion.

Another important part of this study is to test a new device. This device measures something called 'delta-like ligand 3' or DLL3, which is a marker found on some cancer cells. By testing this device, researchers hope to find better ways to identify which patients might benefit most from treatments like obrixtamig in the future.

Key takeaways

New study drug obrixtamig aims to improve survival for advanced neuroendocrine cancer.
Compares new drug plus chemotherapy vs. chemotherapy alone.
Also testing a new medical device for a cancer marker (DLL3).
Participants chosen randomly for either treatment group.
Regular clinic visits and health checks are part of the study.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

This study is for adults whose neuroendocrine cancer has spread or cannot be removed by surgery. This is for cancer that started outside the lungs and is growing quite fast. You might be able to join if your cancer has a specific marker called DLL3.

It's important that you haven't received much treatment for your advanced cancer before. You may have had one cycle of standard chemotherapy (like carboplatin and etoposide) to start with, but not more than that. If you had chemotherapy or radiotherapy for an earlier stage of your cancer, that might be okay if it was at least 6 months ago.

Generally, you need to be in good health and able to carry on with daily activities, even with cancer, to take part.

Quick self-check

I have advanced neuroendocrine cancer that started outside my lungs.
My cancer is growing relatively quickly (doctors measure this).
I haven't had much prior treatment for my advanced cancer, maybe just one cycle of chemotherapy.
I am generally feeling well enough to carry out daily activities.
My doctors have confirmed my tumour has the 'DLL3' marker.
I am 18 years old or older.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you'll be put into one of two groups by chance, like flipping a coin. One group will get the new medicine (obrixtamig) along with standard chemotherapy, followed by obrixtamig alone for up to three years. The other group will receive standard chemotherapy only for about four months.

All medicines are given through a drip into your arm (infusion). You'll have regular visits to the study clinic so doctors can check your health, see how you're reacting, and monitor the size of your tumours. For your first two treatments with obrixtamig, you'll need to stay overnight at the clinic. The total duration of your participation will depend on which group you are in and how you respond to treatment.

Potential risks and benefits

Participating in this study might offer the potential benefit of access to a new treatment (obrixtamig) that could improve survival compared to standard care. However, like all medicines, obrixtamig and chemotherapy can cause side effects, which the doctors will monitor closely. You will be told about all known possible side effects before you decide to join. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (165)

Mayo Clinic
Scottsdale, United States
City of Hope-Duarte-56419
Duarte, United States
Stanford Cancer Center
Palo Alto, United States
University of California San Francisco
San Francisco, United States
University of California Los Angeles
Santa Monica, United States
Mayo Clinic - Florida
Jacksonville, United States
Emory University
Atlanta, United States
The Skip Viragh Outpatient Cancer Research Building
Baltimore, United States
Mayo Clinic, Rochester
Rochester, United States
Washington University School of Medicine
St Louis, United States
Memorial Sloan-Kettering Cancer Center
New York, United States
Icahn School of Medicine at Mount Sinai
New York, United States

+153 more sites — see the official record for the full list.

Common questions

What is neuroendocrine cancer?

It's a type of cancer that starts in special cells called neuroendocrine cells, which are found all over the body. This study focuses on those that start outside the lungs.

What is obrixtamig?

Obrixtamig is a new drug designed to help your immune system fight cancer cells by targeting a specific protein called DLL3 on the cancer cells.

Will I definitely get the new drug?

There's a chance you might, as participants are randomly assigned to either receive obrixtamig plus chemotherapy or chemotherapy alone.

How often will I need to visit the clinic?

You'll have regular visits throughout the study for health checks and to track your progress. The exact schedule will be explained to you.

Can I stop participating if I want to?

Yes, you can leave the study at any time, and it won't affect the care you receive from your doctors.

How to find out more

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com 1-800-243-012 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.