DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
NCT ID: NCT05882058
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
174 participants
INTERVENTIONAL
2023-10-13
2027-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Part 1: open label, randomized, with 2 treatment arms followed by Part 2: open label, non-randomized, 1 treatment arm
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1: Dose group 1
BI 764532, dose 1
BI 764532, dose 1
Part 1: Dose group 2
BI 764532, dose 2
BI 764532, dose 2
Part 2: Expansion cohort
BI 764532, dose 1
BI 764532, dose 1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BI 764532, dose 1
BI 764532, dose 1
BI 764532, dose 2
BI 764532, dose 2
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
3. Part 1: Histologically or cytologically confirmed, cancer of the following histologies:
* Small cell lung cancer (SCLC)
* Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma (MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate cancer (NEPC))
* Large cell neuroendocrine carcinoma (LCNEC) of the lung Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small tumour cells component is predominant and represents at least 50% of the overall tumour tissue.
Patients must have progressed or recurred after standard of care therapy
* SCLC: after at least two prior lines of therapy, including at least one platinum-based regimen; in countries where standard of care in first line therapy includes PD-L1 inhibitor treatment patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment.
* Therapy includes PD-L1 inhibitor treatment; patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment.
* epNEC/LCNEC: after at least one platinum-based regimen. Part 2: Histologically or cytologically confirmed epNEC (except MCC, MTC and NEPC) with centrally assessed DLL3 high expression status. Patients must have progressed or recurred after at least one platinum-based regimen.
4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
5. Measurable lesions as defined per Response Evaluation Criteria In Solid Tumours (RECIST) v 1.1 within 21 days prior to the first dose of BI 764532.
6. Part 1: Availability of archival tumour tissue sample Part 2: Availability of archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample. Following specimens are not allowed: Fine Needle Aspiration (FNA), Cytology samples, decalcified bone samples.
7. Adequate organ function as defined in the protocol.
8. All toxicities related to previous anti-cancer therapies have resolved = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia, peripheral neuropathy, fatigue and endocrinopathies controlled by replacement therapy which must be = CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade).
9. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information
Exclusion Criteria
* Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532.
* Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant central nervous system (CNS) disease.
2. Presence of leptomeningeal disease or, part 2: epidural disease including spinal cord compression.
3. Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade).
Part 2: Active/previous history of interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade). Patients with a history of therapy-related pneumonitis that is considered clinically resolved are eligible.
4. Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
5. Prior anti-cancer therapy:
* Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.
* Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532.
6. Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies.
7. Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Infirmary Cancer Care
Mobile, Alabama, United States
Mayo Clinic-Arizona
Phoenix, Arizona, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Mayo Clinic Cancer Center
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Virginia Commonwealth University Health- Adult Outpatient Pavilion
Richmond, Virginia, United States
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
MHAT UniHospital
Panagyurishte, , Bulgaria
MHAT Heart and brain
Pleven, , Bulgaria
West China Hospital of 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 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, , Taiwan
Leicester Royal Infirmary
Leicester, , United Kingdom
University College Hospital
London, , United Kingdom
The Christie
Manchester, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-504247-13-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1292-4406
Identifier Type: REGISTRY
Identifier Source: secondary_id
1438-0005
Identifier Type: -
Identifier Source: org_study_id