RecruitingPHASE3INTERVENTIONAL

DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy

This study is for adults with advanced small cell lung cancer. It aims to see if adding an experimental medicine called obrixtamig to standard treatment (atezolizumab, carboplatin, and etoposide) helps people live longer compared to standard treatment alone. Obrixtamig is a special type of medicine designed to help your body's immune system fight cancer. The study also investigates a new device that measures a specific marker in cancer cells. Participants are randomly put into two groups: one gets obrixtamig plus standard treatment, and the other gets only standard treatment. Doctors monitor tumour growth and general health for up to three years to see how well the treatments work and check for any side effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Boehringer Ingelheim

Enrolment target

670

Start

13 Apr 2026

Estimated completion

30 Jul 2029

Small Cell Lung Cancer (SCLC)Extensive-stage Small Cell Lung Cancer (ES-SCLC)

What is this study about?

This study, called DAREON® -Lung-1, is investigating a new treatment for advanced small cell lung cancer. This is a type of lung cancer that has spread to different parts of the body. The main goal of the study is to find out if adding a new medicine, obrixtamig, to the usual treatment (which includes atezolizumab, carboplatin, and etoposide) can help people live longer than with the usual treatment alone. Obrixtamig is a special molecule designed to boost your immune system, helping it to recognise and fight cancer cells more effectively.

Alongside checking the new medicine, the study also includes a test for a new medical device. This device is being developed to measure something called DLL3, which is a marker found on some cancer cells. Understanding more about this marker could help doctors in the future to better guide treatments for certain cancers.

Clinical trials like this are very important because they help doctors find better ways to treat serious illnesses. By carefully comparing new treatments with existing ones, researchers can determine if new medicines are safe and effective, potentially leading to improved care for patients with small cell lung cancer.

Key takeaways

This study is testing a new medicine (obrixtamig) for advanced small cell lung cancer.
It aims to see if adding obrixtamig to standard treatment improves survival.
Participation involves being randomly assigned to obrixtamig + standard treatment, or standard treatment alone.
The study lasts up to 3 years with regular hospital visits and health checks.
You might need to stay overnight for the first two new medicine treatments.

Who may be eligible?

To join this study, you must be an adult with small cell lung cancer that has spread (this is called extensive-stage disease). You should not have received any previous treatment specifically for this advanced stage of your cancer. If you had treatment for an earlier stage of lung cancer, you might still be able to join, but only if it finished more than six months ago.

We need a sample of your tumour tissue to check for a specific marker called DLL3. This is done before you start the treatment. If you have cancer that has spread to your brain, you might still be able to join, but only if it's not causing symptoms and has been stable for a certain period, and you're not taking certain medications for it.

Overall, you should be well enough to receive the standard chemotherapy treatments and fit enough for the study, which doctors will assess. There are some conditions that would prevent you from joining, for example, if the cancer has spread to the lining of the brain or spinal cord.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult with small cell lung cancer that has spread?
Have you not had any cancer treatment for this advanced stage yet?
Are you generally well enough for standard cancer treatments?
Do you have a sample of your tumour tissue available for testing?
If you have brain metastases, are they stable and not causing symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive the new study medicine, obrixtamig, mixed with the standard cancer treatment. The other group will receive only the standard cancer treatment. All treatments are given directly into a vein through a drip.

You will be in the study for up to three years. During this time, you'll have regular hospital visits. For your first two treatments involving obrixtamig, if you are in that group, you will need to stay overnight at the hospital. At your visits, doctors will regularly monitor the size of your tumours to see how the treatment is working. They will also carefully check your general health and record any unwanted effects or side effects you might experience. Your commitment helps researchers understand the new treatment better.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of this study is that you might receive a new treatment, obrixtamig, which could be more effective in controlling your cancer than standard treatment alone. However, there's no guarantee the new treatment will work for you, or that it will be better than existing options. Potential risks include experiencing side effects from the study medicines, which will be carefully monitored by the medical team. All treatments can have side effects, and some may be serious. You will be given a full explanation of these. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (236)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Infirmary Cancer Care
Verified postcode
Mobile, United States· Not yet recruiting
University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States· Not yet recruiting
Bioresearch Partner - Hialeah Hospital
Verified postcode
Hialeah, United States· Not yet recruiting
Emory University
Verified postcode
Atlanta, United States· Not yet recruiting
Norton Cancer Institute, Downtown
Verified postcode
Louisville, United States· Not yet recruiting
Epic Medical Research - Monroe
Verified postcode
Monroe, United States· Not yet recruiting
Epic Medical Research - Shreveport
Verified postcode
Shreveport, United States· Not yet recruiting
University of Maryland School of Medicine
Verified postcode
Baltimore, United States· Not yet recruiting
Veterans Affairs Ann Arbor Healthcare System
Verified postcode
Ann Arbor, United States· Not yet recruiting
HCA MidAmerica Division, Inc.
Verified postcode
Kansas City, United States· Not yet recruiting
University of Nebraska Medical Center
Verified postcode
Omaha, United States· Not yet recruiting
AHN Cancer Institute - Allegheny General
Verified postcode
Pittsburgh, United States· Not yet recruiting

Common questions

What is 'small cell lung cancer'?

Small cell lung cancer is a type of lung cancer that can grow and spread quickly. This study is for advanced cases where the cancer has spread to other parts of the body.

What is 'obrixtamig'?

Obrixtamig is a new study medicine, a special type of molecule that aims to help your body's own immune system fight the cancer cells. It's not yet a standard treatment.

Why are some people staying overnight?

For the first two times someone receives obrixtamig, they need to stay overnight. This allows the doctors to closely monitor them for any early reactions or side effects to the new medicine.

What does 'randomly put into groups' mean?

It means you'll be assigned to a treatment group by chance, like drawing names from a hat. This ensures the study is fair and results are reliable, without anyone choosing which treatment you get.

What happens if I want to stop my participation?

You are free to leave the study at any time, for any reason, without explaining why. This decision will not affect the medical care you receive from your doctors.

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.