Actively Recruiting
DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
Led by Boehringer Ingelheim · Updated on 2026-04-27
204
Participants Needed
59
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older and able to give informed consent.
- Histologically or cytologically confirmed small cell lung cancer, extrapulmonary neuroendocrine carcinoma (excluding Merkel cell carcinoma, medullary thyroid cancer, neuroendocrine prostate cancer), or large cell neuroendocrine carcinoma of the lung.
- Disease progression after at least two prior therapies for small cell lung cancer including a platinum-based regimen and PD-L1 inhibitor treatment unless unable to receive checkpoint inhibitors.
- Disease progression after at least one platinum-based regimen for extrapulmonary neuroendocrine carcinoma or large cell neuroendocrine carcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Measurable lesions per RECIST v1.1 within 21 days before first dose.
- Availability of archival tumor tissue sample (FFPE for Parts 2 and 3; no fine needle aspiration, cytology, or decalcified bone samples).
- Adequate organ function as defined in protocol.
- Resolution of prior anti-cancer therapy toxicities to CTCAE Grade 1 (except certain conditions allowed at Grade 2 or any grade for amenorrhea/menstrual disorders).
- Willingness to use effective contraception for women of childbearing potential and men able to father a child.
- For Part 3, willingness to stay within 1 hour travel of study site for 48 hours after first dose and availability of a caregiver.
You will not qualify if you...
- Untreated or symptomatic brain metastases; stable treated brain metastases allowed if radiotherapy/surgery completed at least 2 weeks prior and off steroids and anti-epileptic drugs or stable doses.
- Presence of leptomeningeal disease or epidural disease including spinal cord compression.
- Active or previous interstitial lung disease, pulmonary fibrosis, organizing pneumonia, or non-infectious pneumonitis (except resolved therapy-related pneumonitis for Parts 2 and 3).
- History of severe, life-threatening immune-mediated adverse events or infusion reactions leading to permanent immunotherapy discontinuation.
- Anti-cancer therapy within 4 weeks or 5 half-lives before first dose, or extensive field radiotherapy within 2 weeks.
- Prior treatment with DLL3-targeting T cell engagers or cell therapies.
- Diagnosis of immunodeficiency or immunosuppressive therapy within 7 days before first dose (physiologic steroid replacement allowed).
- Unresolved toxicity from prior anti-tumor therapies as defined in inclusion criteria.
- Additional exclusion criteria apply.
AI-Screening
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Trial Site Locations
Total: 59 locations
1
Infirmary Cancer Care
Mobile, Alabama, United States, 36607
Actively Recruiting
2
Mayo Clinic-Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
4
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
5
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
7
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Actively Recruiting
8
Indiana University
Indianapolis, Indiana, United States, 46202
Completed
9
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Not Yet Recruiting
10
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
11
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Actively Recruiting
12
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Completed
13
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
14
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
15
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
16
Virginia Commonwealth University Health- Adult Outpatient Pavilion
Richmond, Virginia, United States, 23219
Actively Recruiting
17
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
18
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
19
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte, Bulgaria, 4500
Completed
20
MHAT Heart and brain
Pleven, Bulgaria, 5800
Completed
21
West China Hospital, Sichuan University
Chengdu, China, 610041
Actively Recruiting
22
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, China, 310016
Actively Recruiting
23
Qilu Hospital, Shangdong University
Jinan, China, 250012
Actively Recruiting
24
960 Hospital of the Chinese People's Liberation Army
Jinan, China, 250031
Actively Recruiting
25
The Second Affiliated Hospital to Nanchang University
Nanchang, China, 330006
Actively Recruiting
26
Shanghai Chest Hospital
Shanghai, China, 200030
Actively Recruiting
27
HOP Intercommunal
Créteil, France, 94000
Completed
28
Hôpital Cochin
Paris, France, 75014
Completed
29
HOP Civil
Strasbourg, France, 67091
Completed
30
Evangelische Lungenklinik Berlin
Berlin, Germany, 13125
Completed
31
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
32
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
33
Asklepios Fachkliniken München-Gauting
Gauting, Germany, 82131
Completed
34
LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany, 22927
Active, Not Recruiting
35
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Actively Recruiting
36
Aichi Cancer Center Hospital
Aichi, Nagoya, Japan, 464-8681
Actively Recruiting
37
National Cancer Center Hospital East
Chiba, Kashiwa, Japan, 277-8577
Actively Recruiting
38
Sendai Kousei Hospital
Miyagi, Sendai, Japan, 981-0914
Completed
39
Osaka International Cancer Institute
Osaka, Osaka, Japan, 541-8567
Actively Recruiting
40
Kindai University Hospital
Osaka, Sakai, Japan, 590-0197
Actively Recruiting
41
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan, 104-0045
Actively Recruiting
42
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan, 135-8550
Actively Recruiting
43
Hospital CUF Descobertas-Lisboa-69316
Lisbon, Portugal, 1350-352
Actively Recruiting
44
Hospital CUF Porto
Porto, Portugal, 4100-180
Completed
45
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
46
Asan Medical Center
Seoul, South Korea, 05505
Completed
47
Samsung Medical Center
Seoul, South Korea, 06351
Active, Not Recruiting
48
Hospital del Mar
Barcelona, Spain, 08003
Completed
49
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
50
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
51
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
52
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Completed
53
NCKUH
Tainan, Taiwan, 704
Completed
54
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Completed
55
Chang Gung Memorial Hospital, Linkou
Taoyuan County, Taiwan, 333
Completed
56
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
57
University College Hospital
London, United Kingdom, WC1E 6AG
Actively Recruiting
58
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
59
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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