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

ClinicalTrials.gov ID: NCT05882058

Public ClinicalTrials.gov record NCT05882058. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:55 AM EDT

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Official title

DAREON™-5: An Open-label, Multi-center Phase II Dose Selection Trial of Intravenous BI 764532, a DLL3-targeting T Cell Engager, in Patients With Relapsed/Refractory Extensive-stage Small Cell Lung Cancer and in Patients With Other Relapsed/Refractory Neuroendocrine Carcinomas

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 (also called obrixtamig) 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 3 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 and Part 3, all participants receive the same dose of BI 764532. Part 2 and Part 3 are 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.

Study identification

NCT ID: NCT05882058
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Boehringer Ingelheim; Industry
Enrollment: 204 participants

Conditions and interventions

Conditions

Interventions

Drug · Device

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 12, 2023
Primary completion: Dec 16, 2027
Completion: Jun 7, 2028
Last update posted: Jul 22, 2026

2023 – 2028

United States locations

U.S. sites: 16
U.S. states: 12
U.S. cities: 16

Facility	City	State	ZIP	Site status
Infirmary Cancer Care	Mobile	Alabama	36607	Recruiting
Mayo Clinic-Arizona	Phoenix	Arizona	85054	Recruiting
Valkyrie Clinical Trials	Los Angeles	California	90067	Recruiting
University of California San Francisco	San Francisco	California	94143	Recruiting
Mayo Clinic Cancer Center	Jacksonville	Florida	32224	Recruiting
University of Miami	Miami	Florida	33136	Recruiting
H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	33612	Recruiting
Indiana University	Indianapolis	Indiana	46202	Completed
University of Kansas Cancer Center	Westwood	Kansas	66205	Completed
University of Kentucky Medical Center	Lexington	Kentucky	40536	Recruiting
University of Maryland School of Medicine	Baltimore	Maryland	21201	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Completed
Mayo Clinic, Rochester	Rochester	Minnesota	55905	Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health	New York	New York	10016	Completed
Montefiore Medical Center	The Bronx	New York	10461	Recruiting
Virginia Commonwealth University Health- Adult Outpatient Pavilion	Richmond	Virginia	23219	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05882058, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 22, 2026 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05882058 live on ClinicalTrials.gov.

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