Active not recruitingPHASE1INTERVENTIONAL

DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy

This research study, called DAREON™-9, is for adults in the UK with a specific type of lung cancer known as extensive stage small cell lung cancer. This means the cancer has spread. Participants will have already received platinum-based chemotherapy and are now eligible for another type of chemotherapy. The study aims to find the highest dose of a new experimental medicine, BI 764532, that people can safely take when combined with a single chemotherapy drug. BI 764532 is a new type of drug that could help your body's immune system fight the cancer. We want to see how well patients tolerate this new combination and if the new drug helps. This is a Phase 1 study, meaning it's an early step in testing new treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

Start

14 Feb 2024

Estimated completion

30 Jul 2027

Small Cell Lung Carcinoma (SCLC)

What is this study about?

This study is looking for adults with a type of lung cancer called small cell lung cancer (SCLC) that has spread, also known as 'extensive stage'. Participants will have already had treatment with chemotherapy that included a 'platinum-based' drug, and their cancer has either grown or come back. They also need to be suitable for another type of chemotherapy treatment.

The main aim of this study is to discover the highest amount, or 'dose', of a new medicine called BI 764532 that people can safely tolerate when given alongside a standard chemotherapy drug. BI 764532 is a special molecule that works a bit like an antibody. It's designed to help your body's own immune system recognise and fight the cancer cells. By finding a safe dose, researchers can then move on to future studies to see how effective this new treatment might be.

Taking part in this study means you would be given BI 764532 along with chemotherapy, and doctors would carefully monitor your health. This is an early-stage study (Phase 1), which means it's one of the first times this new drug is being tested in people. It’s an important step in developing new treatments for small cell lung cancer.

Key takeaways

This study is for adults with advanced small cell lung cancer.
It tests a new drug (BI 764532) combined with chemotherapy.
The main goal is to find the safest dose of the new drug.
Participants must have received previous platinum-based chemotherapy.
Regular clinic visits and health checks are part of taking part.

Who may be eligible?

This study is looking for adults aged 18 or over. To be considered, you must have small cell lung cancer that has spread (extensive stage). You should also have already received a platinum-based chemotherapy treatment, and your cancer has either come back or gotten worse. You'll also need to be suitable for another standard chemotherapy treatment.

There are also some reasons why you might not be able to join. For example, if you have already been in this specific study before, or if you are currently in another study involving a new drug or device. Certain types of brain tumours or other serious health conditions might also mean you can't take part. The study team will check your full medical history to confirm if you are suitable.

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 18 years old or older?
Have you been diagnosed with small cell lung cancer that has spread?
Have you already had platinum-based chemotherapy?
Is your cancer still active or has it come back after previous treatment?
Are you considered well enough by your doctor to receive another chemotherapy treatment?
Do you have a good general health status (ECOG performance status 0-1)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will continue to receive the study medicines as long as they seem to be helping you and you are tolerating them well. During this time, you would need to visit the study clinic regularly. The exact number and timing of visits will depend on your individual response to the treatment.

At these visits, the doctors and nurses will keep a close eye on your health. They will perform health checks, take blood or other lab tests, and ask you about any new health problems or side effects you might be experiencing. These checks are very important to make sure the treatment is safe for you. The study team will explain the full schedule of visits and tests if you are eligible and interested.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new experimental treatment that could help fight your cancer, which might not otherwise be available. However, as this is an early-stage study testing a new drug, there’s no guarantee it will help or improve your condition. Like all medicines, BI 764532 and the chemotherapy can cause side effects. The study team will monitor you closely for any problems and explain all known or potential risks. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

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

MedStar Georgetown University Hospital
Verified postcode
Washington D.C., United States
Mayo Clinic - Florida
Verified postcode
Jacksonville, United States
University of Miami
Verified postcode
Miami, United States
Virginia Commonwealth University
Verified postcode
Richmond, United States
INS Curie
Verified postcode
Paris, France
HOP Civil
Verified postcode
Strasbourg, France
Institut Gustave Roussy
Verified postcode
Villejuif, France
Universitätsklinikum Carl Gustav Carus Dresden
Verified postcode
Dresden, Germany
Universitätsklinikum Erlangen
Verified postcode
Erlangen, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Verified postcode
Heidelberg, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Verified postcode
Mainz, Germany
Universitätsklinikum Würzburg AÖR
Verified postcode
Würzburg, Germany

Common questions

What is 'extensive stage small cell lung cancer'?

This means your small cell lung cancer has spread beyond the main area in your chest to other parts of your body.

What is BI 764532?

It's a new experimental drug, like an antibody, designed to help your body's immune system fight cancer cells. It's not yet approved and is being tested in this study.

What does 'tolerated' mean?

It means how well your body handles the medicine and how many side effects you experience. The study aims to find the dose that is safe and manageable.

What is a 'Phase 1' study?

Phase 1 studies are early research studies that mainly focus on finding a safe dose of a new drug and understanding its side effects, rather than how effective it is.

Will I still receive standard chemotherapy?

Yes, if you meet the criteria, you will receive BI 764532 in combination with a standard single chemotherapy drug.