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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Boehringer Ingelheim 1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com


Study Location:

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

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

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Carcinoma
Small Cell Lung Carcinoma
Carcinoma, Neuroendocrine
Neuroendocrine Tumors


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study is open to adults with small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.

The purpose of this study is to find a suitable dose of BI 764532 that people with advanced cancer can tolerate. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer.

The study has 2 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2, all participants receive the same dose of BI 764532. Part 2 is open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma.

All participants receive BI 764532 as an infusion into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment.

The first study visits include an overnight stay to monitor participants´ safety. Doctors record any unwanted effects and regularly check the general health of the participants.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2023 Oct 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : BI 764532, dose 1

Intervention Arm Group : Part 1: Dose group 1;Part 2: Expansion cohort;

Intervention Type : DRUG
Intervention Description : BI 764532, dose 2

Intervention Arm Group : Part 1: Dose group 2;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Christie
    Manchester
    M20 4BX
  • Leicester Royal Infirmary
    Leicester
    LE1 5WW
  • University College Hospital
    London
    WC1E 6AG
  • Freeman Hospital
    Newcastle Upon Tyne
    NE7 7DN


The study is sponsored by Boehringer Ingelheim




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Read full details for Trial ID: NCT05882058
Last updated 17 April 2025

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