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 Topotecan
- Conditions
- Small Cell Lung Carcinoma (SCLC)
- Interventions
- Registration Number
- NCT05990738
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive topotecan treatment.
The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with topotecan. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and topotecan as infusions into a vein. As an alternative, topotecan may also be taken orally (tablets).
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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 Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- 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.
- 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.
- Patients must be eligible for single agent chemotherapy treatment (used in the trial) according to label.
- Availability of archival tumour tissue sample.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Further inclusion criteria apply.
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Previous treatment in this trial.
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Current enrolment in another investigational device or drug trial, or <30 days since ending another investigational device or drug trial(s).
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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.
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Presence of leptomeningeal carcinomatosis.
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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).
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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).
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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.
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Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ
- other effectively treated malignancy that is considered cured by local treatment Further exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: BI 764532 low dose + topotecan/single agent chemotherapy BI 764532 - Part A: BI 764532 medium dose + topotecan/single agent chemotherapy BI 764532 - Part A: BI 764532 low dose + topotecan/single agent chemotherapy Topotecan - Part A: BI 764532 high dose + topotecan/single agent chemotherapy Topotecan - Part A: BI 764532 low dose + topotecan/single agent chemotherapy Single agent chemotherapy - Part A: BI 764532 medium dose + topotecan/single agent chemotherapy Topotecan - Part A: BI 764532 medium dose + topotecan/single agent chemotherapy Single agent chemotherapy - Part A: BI 764532 high dose + topotecan/single agent chemotherapy BI 764532 - Part A: BI 764532 high dose + topotecan/single agent chemotherapy Single agent chemotherapy - Part B: BI 764532 + topotecan Topotecan - Part B: BI 764532 + topotecan BI 764532 -
- Primary Outcome Measures
Name Time Method Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period up to 9 weeks Part B: Occurrence of DLTs during the on-treatment period up to 36 months Part B: Occurrence of AEs during the on-treatment period up to 36 months
- Secondary Outcome Measures
Name Time Method Part A: Occurrence of DLTs during the on-treatment period up to 36 months Part A: Occurrence of AEs during the on-treatment period up to 36 months Part B: Objective response up to 36 months Part B: Duration of response up to 36 months
Trial Locations
- Locations (12)
Mayo Clinic - Florida
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, 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