Small Cell Lung CarcinomaPhase 2NCT05882058
DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
A Phase 2 study testing BI 764532, dose 1, BI 764532, dose 2 and Ventana DLL3 RxDx assay in people with Small Cell Lung Carcinoma and Neuroendocrine Neoplasms, run by Boehringer Ingelheim at 59 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma, Neuroendocrine Neoplasms, Extra-pulmonary Neuroendocrine Carcinoma
- What is being tested?
- BI 764532, dose 1, BI 764532, dose 2 and Ventana DLL3 RxDx assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 59 sitesin 12 countries
- Study dates
- 13 Oct 2023to 8 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).
- 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.
- 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.
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- 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 and part 3: 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.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.,
- 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.
- Part 1: Availability of archival tumour tissue sample Part 2 and part 3: 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.
- Adequate organ function as defined in the protocol.
- 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).
- 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
- Only for Part 3, at the timepoint of Screening 02:
- For Cycle 1, patients should be willing to stay within 1 hour driving distance for 48 hours after IMP administration and confirm availability of a caregiver for the same timeframe.
- Patients should be considered suitable by the investigator to follow instructions applicable to the reduced monitoring cohort, such as taking their temperature and administration of oral medication at home if needed.
Who cannot join
- Untreated or symptomatic brain metastases. (Part 2 and part 3: identified during the mandatory assessment by brain MRI within 21 days before first trial drug administration.) Participants with treated, stable brain metastases are eligible provided they meet the following 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.
- Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression.
- Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade).
- Part 2 and part 3: 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.
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- 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.
- 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.
- Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies.
- 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.
- Unresolved toxicity from prior anti-tumour therapy, defined in the inclusion criteria.
- Further exclusion criteria apply.
Trial locations and contacts
59 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
59 sites in 12 countries
United States16 sites, 12 recruiting
- Recruiting
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Completed
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Completed
Indiana University
Indianapolis, Indiana, 46202
- Recruiting
Mayo Clinic Cancer Center
Jacksonville, Florida, 32224
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Miami
Miami, Florida, 33136
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Infirmary Cancer Care
Mobile, Alabama, 36607
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Completed
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
- Recruiting
Mayo Clinic-Arizona
Phoenix, Arizona, 85054
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Virginia Commonwealth University Health- Adult Outpatient Pavilion
Richmond, Virginia, 23219
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Completed
University of Kansas Cancer Center
Westwood, Kansas, 66205
Japan7 sites, 6 recruiting
- Recruiting
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Completed
Sendai Kousei Hospital
Miyagi, Sendai, 981-0914
- Recruiting
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kindai University Hospital
Osaka, Sakai, 590-0197
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
China6 sites, 6 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Qilu Hospital, Shangdong University
Jinan, 250012
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
960 Hospital of the Chinese People's Liberation Army
Jinan, 250031
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai Chest Hospital
Shanghai, 200030
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Germany6 sites, 3 recruiting
- Completed
Evangelische Lungenklinik Berlin
Berlin, 13125
- Recruiting
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Erlangen
Erlangen, 91054
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Completed
Asklepios Fachkliniken München-Gauting
Gauting, 82131
- Active, not recruiting
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
- Recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Spain5 sites, 3 recruiting
- Completed
Hospital del Mar
Barcelona, 08003
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Completed
Hospital Clinico Universitario de Valencia
Valencia, 46010
United Kingdom4 sites, 4 recruiting
- Recruiting
Leicester Royal Infirmary
Leicester, LE1 5WW
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
University College Hospital
London, WC1E 6AG
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Christie Hospital
Manchester, M20 4BX
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
France3 sites
- Completed
HOP Intercommunal
Créteil, 94000
- Completed
Hôpital Cochin
Paris, 75014
- Completed
HOP Civil
Strasbourg, 67091
South Korea3 sites, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 03722
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Completed
Asan Medical Center
Seoul, 05505
- Active, not recruiting
Samsung Medical Center
Seoul, 06351
Taiwan3 sites
- Completed
NCKUH
Tainan, 704
- Completed
Taipei Veterans General Hospital
Taipei, 11217
- Completed
Chang Gung Memorial Hospital, Linkou
Taoyuan County, 333
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Bulgaria2 sites
- Completed
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte, 4500
- Completed
MHAT Heart and brain
Pleven, 5804
Portugal2 sites
- Completed
Hospital CUF Descobertas-Lisboa-69316
Lisbon, 1350-352
- Completed
Hospital CUF Porto
Porto, 4100-180
About this study
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
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.
Read more
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
- Small Cell Lung Carcinoma, Neuroendocrine Neoplasms, Extra-pulmonary Neuroendocrine Carcinoma
- Being tested
- BI 764532, dose 1, BI 764532, dose 2, Ventana DLL3 RxDx assay
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 764532, dose 1Drug
Also called Obrixtamig
BI 764532, dose 1
BI 764532, dose 2Drug
Also called Obrixtamig
BI 764532, dose 2
Ventana DLL3 RxDx assayDevice
Ventana DLL3 RxDx assay
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose group 1 | Experimental | Not described Receives: Drug: BI 764532, dose 1 |
| Part 1: Dose group 2 | Experimental | Not described Receives: Drug: BI 764532, dose 2 |
| Part 2: Expansion cohort | Experimental | Not described Receives: Drug: BI 764532, dose 1; Device: Ventana DLL3 RxDx assay |
| Part 3: Expansion cohort | Experimental | Not described Receives: Drug: BI 764532, dose 1; Device: Ventana DLL3 RxDx assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR)
according to RECIST v 1.1 by investigator assessment from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.
Measured: up to 26 months
Part 1: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period
Measured: up to 26 months
Part 2: Objective response (OR)
Objective response is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v 1.1 by blinded independent central review from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent
Measured: up to 27 months
Part 3: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period
Measured: up to 23 months
Part 3: Objective response (OR) by blinded independent central review
Measured: up to 23 months
Secondary outcomes (11)
Part 1: Duration of objective response (DOR) based on investigator assessment
DOR is defined as the time from first documented confirmed OR until the earliest date of disease progression or death among patients with confirmed OR.
Measured: up to 26 months
Part 1: Progression-free survival (PFS) based on investigator assessment
PFS is defined as the time from treatment start until the earliest date of tumour progression according RECIST v 1.1 or death from any cause, whichever occurs first.
Measured: up to 26 months
Part 1: Disease control (DC), defined as best overall response of CR or PR or stable disease (SD) based on investigator assessment
where best overall response is defined according to RECIST v 1.1, from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent
Measured: up to 26 months
Part 1, 2, and 3: Overall survival (OS), defined as the time from treatment start until death from any cause
Measured: up to 26 months
Part 1, 2, and 3: Change from baseline in EORTC QLQ-C30 physical functioning domain score
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) The QLQ-C30 is comprised of 30 questions. It incorporates both multi-item scales and single-item measures. These include
- one global health status/Quality of Life (QoL) scale,
- five functional scales (physical, role, cognitive, emotional, and social),
- three symptom scales (fatigue, pain, and nausea and vomiting),
- and six single items to assess dyspnea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties.
All scales and single-item measures range in score from 0 to 100.
- A high score for a functional scale represents a high/healthy level of functioning.
- A high score for the global health status/QoL represents a high QoL.
- A high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: at baseline, at month 26
Part 1, 2, and 3: Change from baseline in EORTC QLQ-C30 role functioning domain score
Measured: at baseline, at month 26
Part 1, 2, and 3: Occurrence of treatment-emergent AEs leading to study drug discontinuation during the on-treatment period
Measured: up to 26 months
Part 2 and 3: Duration of objective response (DOR) based on blinded independent central review
Measured: up to 27 months
Part 2 and 3: Progression-free survival (PFS) based on blinded independent central review
Measured: up to 27 months
Part 2 and 3: Disease control (DC) based on blinded independent central review
Measured: up to 27 months
Part 2: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period
Measured: up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start13 Oct 2023
- Primary completion17 Dec 2027 (estimated)
- Study completion8 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial consists of 2 parts: Part 1: open label, randomized, with 2 treatment arms followed by: Part 2: open label, non-randomized, 1 treatment arm followed by: Part 3: open label, non-randomized, 1 treatment arm
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882058
- Sponsor's protocol ID
- 1438-0005
- Other IDs
- 2023-504247-13-00, U1111-1292-4406, 2023
- Status last verified
- Jul 2026
- First submitted
- 22 May 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05882058
- Acronym / sponsor ID
- 1438-0005
- Conditions
- Small Cell Lung Carcinoma, Neuroendocrine Neoplasms, Extra-pulmonary Neuroendocrine Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 17 Dec 2027 (estimated)
- Study completion
- 8 Jun 2028 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The trial consists of 2 parts: Part 1: open label, randomized, with 2 treatment arms followed by: Part 2: open label, non-randomized, 1 treatment arm followed by: Part 3: open label, non-randomized, 1 treatment arm
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose group 1 | Experimental | Drug: BI 764532, dose 1 |
| Part 1: Dose group 2 | Experimental | Drug: BI 764532, dose 2 |
| Part 2: Expansion cohort | Experimental | Drug: BI 764532, dose 1, Device: Ventana DLL3 RxDx assay |
| Part 3: Expansion cohort | Experimental | Drug: BI 764532, dose 1, Device: Ventana DLL3 RxDx assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).
- 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.
- Part 1: Histologically or cytologically confirmed, cancer of the following histologies:
- Patients must have progressed or recurred after standard of care therapy
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.,
Key exclusion criteria (14 listed)
- Untreated or symptomatic brain metastases. (Part 2 and part 3: identified during the mandatory assessment by brain MRI within 21 days before first trial drug administration.) Participants with treated, stable brain metastases are eligible provided they meet the following criteria:
- Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression.
- Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade).
- Part 2 and part 3: 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 764532, dose 1Also: ObrixtamigBI 764532, dose 1 | Drug | Part 1: Dose group 1, Part 2: Expansion cohort, Part 3: Expansion cohort |
| BI 764532, dose 2Also: ObrixtamigBI 764532, dose 2 | Drug | Part 1: Dose group 2 |
| Ventana DLL3 RxDx assayVentana DLL3 RxDx assay | Device | Part 2: Expansion cohort, Part 3: Expansion cohort |
Primary outcome
Part 1: Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR)
Time frame: up to 26 months
according to RECIST v 1.1 by investigator assessment from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.
Part 1: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period
Time frame: up to 26 months
Part 2: Objective response (OR)
Time frame: up to 27 months
Objective response is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v 1.1 by blinded independent central review from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent
Part 3: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period
Time frame: up to 23 months
Part 3: Objective response (OR) by blinded independent central review
Time frame: up to 23 months
11 secondary outcomes
Part 1: Duration of objective response (DOR) based on investigator assessment
Time frame: up to 26 months
Part 1: Progression-free survival (PFS) based on investigator assessment
Time frame: up to 26 months
Part 1: Disease control (DC), defined as best overall response of CR or PR or stable disease (SD) based on investigator assessment
Time frame: up to 26 months
Part 1, 2, and 3: Overall survival (OS), defined as the time from treatment start until death from any cause
Time frame: up to 26 months
Part 1, 2, and 3: Change from baseline in EORTC QLQ-C30 physical functioning domain score
Time frame: at baseline, at month 26
Part 1, 2, and 3: Change from baseline in EORTC QLQ-C30 role functioning domain score
Time frame: at baseline, at month 26
Part 1, 2, and 3: Occurrence of treatment-emergent AEs leading to study drug discontinuation during the on-treatment period
Time frame: up to 26 months
Part 2 and 3: Duration of objective response (DOR) based on blinded independent central review
Time frame: up to 27 months
Part 2 and 3: Progression-free survival (PFS) based on blinded independent central review
Time frame: up to 27 months
Part 2 and 3: Disease control (DC) based on blinded independent central review
Time frame: up to 27 months
Part 2: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period
Time frame: up to 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
59 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 764532, dose 1, BI 764532, dose 2 and Ventana DLL3 RxDx assay in people with Small Cell Lung Carcinoma and Neuroendocrine Neoplasms, run by Boehringer Ingelheim at 59 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Japan, China, Germany, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) (time frame: up to 26 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.