DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy
NCT ID: NCT05990738
Last Updated: 2025-07-22
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
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RECRUITING
PHASE1
90 participants
INTERVENTIONAL
2024-02-14
2027-07-30
Brief Summary
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The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer.
Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study site regularly. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: BI 764532 low dose + topotecan/single agent chemotherapy
BI 764532
BI 764532
Topotecan
Topotecan
Single agent chemotherapy
single agent chemotherapy
Part A: BI 764532 medium dose + topotecan/single agent chemotherapy
BI 764532
BI 764532
Topotecan
Topotecan
Single agent chemotherapy
single agent chemotherapy
Part A: BI 764532 high dose + topotecan/single agent chemotherapy
BI 764532
BI 764532
Topotecan
Topotecan
Single agent chemotherapy
single agent chemotherapy
Part B: BI 764532 + topotecan
BI 764532
BI 764532
Topotecan
Topotecan
Interventions
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BI 764532
BI 764532
Topotecan
Topotecan
Single agent chemotherapy
single agent chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
3. Histologically or cytologically confirmed small cell lung cancer (SCLC). Patients with tumours with mixed histology are eligible only if SCLC component is predominant and represent at least 50% of the overall tumour tissue.
4. Extensive stage - small cell lung cancer (ES-SCLC) that progressed or recurred following platinum-based treatment, and anti- programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) as applicable.
5. Patients must be eligible for single agent chemotherapy treatment (used in the trial) according to label.
6. Availability of archival tumour tissue sample.
Exclusion Criteria
2. Current enrolment in another investigational device or drug trial, or \<30 days since ending another investigational device or drug trial(s).
3. Untreated or symptomatic brain metastases. Participants with treated, stable brain metastases are eligible provided they meet the following criteria:
* Radiotherapy or major surgery for brain metastases was completed at least 2 weeks (for radiotherapy) or 4 weeks (for major brain metastases surgery) 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.
4. Presence of leptomeningeal carcinomatosis.
5. Prior participation in clinical trials of BI 764532, including receiving standard of care in these trials OR prior treatment with T cell engager (TcE) or cell therapies targeting delta-like ligand 3 (DLL3).
6. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlled by replacement therapy).
7. Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement.
8. Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except
1. effectively treated non-melanoma skin cancers
2. effectively treated carcinoma in situ of the cervix
3. effectively treated ductal carcinoma in situ
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
East Carolina University
Greenville, North Carolina, United States
Virginia Commonwealth University
Richmond, Virginia, United States
INS Curie
Paris, , France
HOP Civil
Strasbourg, , France
INS Gustave Roussy
Villejuif, , France
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsklinikum Würzburg AÖR
Würzburg, , Germany
Polish Mother's Memorial Hospital - Research Institute
Lodz, , Poland
Leicester Royal Infirmary
Leicester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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2023-506007-26-00
Identifier Type: CTIS
Identifier Source: secondary_id
U1111-1293-4098
Identifier Type: REGISTRY
Identifier Source: secondary_id
1438-0009
Identifier Type: -
Identifier Source: org_study_id
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