RecruitingPHASE2INTERVENTIONAL

DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

This study, called DAREON™-5, is looking for adults with advanced small cell lung cancer or other specific neuroendocrine cancers. These are cancers where previous treatments haven't worked or there aren't standard options available. The main goals are to find a safe and tolerable dose of a new treatment, BI 764532 (also known as obrixtamig), and to see if it can help shrink tumours. BI 764532 works with your immune system to potentially fight cancer. The study involves different doses and checks participants' health closely. Some parts of the study focus on a specific type of cancer called extrapulmonary neuroendocrine carcinoma.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Boehringer Ingelheim

Enrolment target

204

Start

13 Oct 2023

Estimated completion

24 Feb 2028

Small Cell Lung Carcinoma Neuroendocrine Neoplasms Extra-pulmonary Neuroendocrine Carcinoma

What is this study about?

This study, called DAREON™-5, is looking into a new treatment for adults who have advanced small cell lung cancer or certain other types of neuroendocrine cancers. Neuroendocrine cancers are a group of cancers that start in specialized cells called neuroendocrine cells. These cells have features of both nerve cells and hormone-producing cells. This study is specifically for people whose cancer has either come back after treatment or for whom standard treatments are no longer working or available.

The main idea behind this study is to test a new medicine called BI 764532, which is sometimes also referred to as obrixtamig. This medicine is designed to work with your body's immune system to fight cancer. The researchers want to find out what dose of BI 764532 is safest for people to take and can be tolerated well. They also want to see if this new treatment can make tumours shrink.

The study is divided into three main parts. In the first part, participants are put into two groups by chance, much like flipping a coin, to receive one of two different doses of BI 764532. In the later parts of the study, everyone will receive the same dose. These later parts of the study focus only on people with a specific type of cancer called extrapulmonary neuroendocrine carcinoma. The doctors will keep a close eye on participants' health and any effects of the treatment throughout the study.

Key takeaways

This study tests a new treatment (BI 764532/obrixtamig) for advanced small cell lung cancer and other neuroendocrine cancers.
It aims to find a safe and tolerable dose, and see if the treatment shrinks tumours.
Participants will receive the treatment as an infusion into a vein.
Close monitoring for safety and side effects is a key part of the study.
The study involves regular visits to the clinic, with an initial overnight stay.

Who may be eligible?

This study is looking for adults with specific types of advanced cancer. You must be at least 18 years old.

For the first part of the study, you could be eligible if you have small cell lung cancer, certain types of extrapulmonary neuroendocrine carcinoma, or a specific kind of large cell neuroendocrine carcinoma of the lung. Your cancer must have either come back or gotten worse after previous treatments. For example, if you have small cell lung cancer, you would need to have already had at least two different treatments, including a chemotherapy treatment containing platinum.

For later parts of the study, it's specifically for people with certain extrapulmonary neuroendocrine carcinomas that also show a particular marker called DLL3. Your doctor will be able to tell you more about this. Overall, you need to be generally well enough to take part, meaning you can mostly go about your daily activities with little to no difficulty.

Quick self-check

Are you 18 years old or older?
Do you have small cell lung cancer or a specific neuroendocrine cancer?
Has your cancer progressed or come back after previous treatments?
Are you generally able to go about your daily activities without much difficulty?

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

What does participation involve?

If you decide to take part in this study, the new treatment, BI 764532, will be given to you as a drip into a vein (an infusion). This will happen regularly, and how long you receive the treatment depends on whether it helps you and if you tolerate it well. You will need to visit the study clinic regularly for appointments. The number of visits will depend on how your body reacts to the treatment.

The very first visits will include an overnight stay in the clinic. This is so the doctors and nurses can carefully monitor you after your first treatment to make sure you are safe. During your time in the study, the medical team will regularly check your overall health and look for any unwanted side effects. They will also do tests to see if the treatment is working. You can stay on treatment for the maximum duration planned for the study if it continues to benefit you.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The main potential benefit for you might be that the new treatment, BI 764532, could help shrink your tumour, especially if other treatments haven't worked or aren't available. However, there's no guarantee that the treatment will work for everyone, and it might not be better than existing treatments. As with any medicine, there's a risk of side effects. The study team will closely monitor you for any unwanted effects and will always prioritise your safety. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (59)

Infirmary Cancer Care
Mobile, United States· Recruiting
Mayo Clinic-Arizona
Phoenix, United States· Recruiting
Valkyrie Clinical Trials
Los Angeles, United States· Recruiting
University of California San Francisco
San Francisco, United States· Recruiting
Mayo Clinic Cancer Center
Jacksonville, United States· Recruiting
University of Miami
Miami, United States· Recruiting
H. Lee Moffitt Cancer Center and Research Institute
Tampa, United States· Recruiting
Indiana University
Indianapolis, United States· Completed
University of Kansas Cancer Center
Westwood, United States· Not yet recruiting
University of Kentucky Medical Center
Lexington, United States· Recruiting
University of Maryland School of Medicine
Baltimore, United States· Recruiting
Dana-Farber Cancer Institute
Boston, United States· Completed

+47 more sites — see the official record for the full list.

Common questions

What is BI 764532?

BI 764532, also known as obrixtamig, is a new experimental medicine that works with your immune system to potentially fight cancer cells.

What types of cancer is this study for?

This study is for adults with advanced small cell lung cancer or specific types of neuroendocrine cancers, especially if previous treatments haven't worked well.

Will I know which dose I'm getting?

In the first part of the study, you'll be randomly assigned to one of two different doses, so you might not know which one you're getting at first. In later parts, everyone receives the same dose.

How is the treatment given?

The treatment, BI 764532, is given as an infusion, which means it will be delivered through a drip into a vein.

What does 'advanced cancer' mean in this study?

It means the cancer has spread or is at a stage where previous treatments were not successful, or there are no standard treatments available.

How to find out more

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com 1-800-243-0127 Official trial record

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