Actively Recruiting
DAREON1-5: A Phase II Trial Testing Different Doses of BI 764532 Given by IV in Patients With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer and Other Neuroendocrine Carcinomas
Led by Boehringer Ingelheim · Updated on 2026-04-27
204
Participants Needed
59
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BI 764532 (obrixtamig), an antibody-like molecule that may help the immune system fight cancer, in adults with small cell lung cancer or other neuroendocrine tumors. The study focuses on people with advanced cancer for whom previous treatments were unsuccessful or no standard therapies exist. This phase II trial aims to find a suitable dose of BI 764532 that patients can tolerate and to assess whether it can shrink tumors. The study has three parts. In Part 1, participants are randomly assigned to receive one of two different doses of BI 764532 through an intravenous infusion. In Parts 2 and 3, all participants receive the same dose of BI 764532. Those parts are open to people with a specific tumor type called extrapulmonary neuroendocrine carcinoma. Treatment continues as long as it is beneficial and tolerable, with regular visits to the study site. Initial visits include an overnight stay to monitor safety. Participants are closely monitored throughout the study for their health and any side effects. Doctors record any unwanted effects and regularly assess tumor response and quality of life measures. The study tracks outcomes such as tumor shrinkage, safety events, progression-free survival, overall survival, and physical and role functioning over periods up to 27 months. The total number of visits depends on each participant's response and tolerance to treatment.
CONDITIONS
Brief 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 who can legally consent
- Signed informed consent before joining the trial
- Histologically or cytologically confirmed small cell lung cancer, extra-pulmonary neuroendocrine carcinoma (excluding certain types), or large cell neuroendocrine carcinoma of the lung
- Tumor must have progressed after standard therapies (at least two prior lines for small cell lung cancer, at least one for neuroendocrine carcinoma)
- ECOG performance status of 0 or 1
- Measurable lesions within 21 days before first dose
- Availability of appropriate archival tumor tissue samples
- Adequate organ function as defined in the protocol
- Previous treatment toxicities resolved to specified criteria
- Use of effective birth control for women of childbearing potential and men able to father a child
- For Part 3, willingness to stay near study site for 48 hours after first dose and availability of a caregiver
You will not qualify if you...
- Untreated or symptomatic brain metastases; treated stable brain metastases with specific conditions allowed
- Presence of leptomeningeal disease or epidural disease including spinal cord compression
- History of interstitial lung disease, pulmonary fibrosis, organizing pneumonia, or non-infectious pneumonitis (with some exceptions)
- Severe immune-related adverse events or infusion reactions from prior immunotherapy
- Recent anti-cancer therapy within defined time frames prior to study drug
- Prior treatment with DLL3-targeting T cell engagers or cell therapies
- Diagnosis of immunodeficiency or recent immunosuppressive therapy
- Unresolved toxicity from prior anti-tumor therapies
- Additional exclusion criteria as detailed in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 26 to 27 months depending on trial part
Participants receive different doses of BI 764532 given by IV as treatment for relapsed or refractory extensive-stage small cell lung cancer or other neuroendocrine carcinomas.
Regular visits during treatment as scheduled by the study team
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
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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