DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony histologicznie lub cytologicznie rak płuc drobnokomórkowy lub nowotwór neuroendokrynny
- •Progresja lub nawrót choroby po co najmniej dwóch wcześniejszych liniach chemioterapii (w tym chemioterapię platynową)
- •Ogólny stan zdrowia oceniony jako 0 lub 1 w skali ECOG (potrafi się poruszać i opiekować sobą)
- •Zmierzalne ogniska nowotworowe widoczne w badaniach obrazowych
- •Podpisana świadoma zgoda na udział w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 23, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (59)
Infirmary Cancer Care
Mobile, United States
Mayo Clinic-Arizona
Phoenix, United States
Valkyrie Clinical Trials
Los Angeles, United States
University of California San Francisco
San Francisco, United States
Mayo Clinic Cancer Center
Jacksonville, United States
University of Miami
Miami, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, United States
Indiana University
Indianapolis, United States
University of Kansas Cancer Center
Westwood, United States
University of Kentucky Medical Center
Lexington, United States
University of Maryland School of Medicine
Baltimore, United States
Dana-Farber Cancer Institute
Boston, United States
Mayo Clinic, Rochester
Rochester, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, United States
Montefiore Medical Center
The Bronx, United States
Virginia Commonwealth University Health- Adult Outpatient Pavilion
Richmond, United States
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte, Bulgaria
MHAT Heart and brain
Pleven, Bulgaria
West China Hospital, Sichuan University
Chengdu, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, China
Qilu Hospital, Shangdong University
Jinan, China
960 Hospital of the Chinese People's Liberation Army
Jinan, China
The Second Affiliated Hospital to Nanchang University
Nanchang, China
Shanghai Chest Hospital
Shanghai, China
HOP Intercommunal
Créteil, France
Hôpital Cochin
Paris, France
HOP Civil
Strasbourg, France
Evangelische Lungenklinik Berlin
Berlin, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Asklepios Fachkliniken München-Gauting
Gauting, Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Aichi Cancer Center Hospital
Aichi, Nagoya, Japan
National Cancer Center Hospital East
Chiba, Kashiwa, Japan
Sendai Kousei Hospital
Miyagi, Sendai, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Kindai University Hospital
Osaka, Sakai, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan
Hospital CUF Descobertas-Lisboa-69316
Lisbon, Portugal
Hospital CUF Porto
Porto, Portugal
Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital del Mar
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
NCKUH
Tainan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan County, Taiwan
Leicester Royal Infirmary
Leicester, United Kingdom
University College Hospital
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Trial contact
Boehringer Ingelheim
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/10/2026.
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