DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer
- Conditions
- Small Cell Lung Carcinoma (SCLC)
- Interventions
- Registration Number
- NCT06077500
- 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 are eligible for standard of care including chemotherapy and anti-PD-L1 (Programmed Cell Death Ligand 1) immunotherapy.
The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with standard of care. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and different standard treatments as infusions into a vein.
If there is benefit for the participants and if they can tolerate it, the treatment is given for the entire duration of the study. 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
- 60
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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)
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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
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Histologically or cytologically confirmed extensive-stage small cell lung carcinoma (ES-SCLC)
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Availability of archival tumour tissue
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Patients must be eligible for platinum+etoposide+anti-Programmed Cell Death Ligand 1 (PD-L1) regimen as first line standard of care (SoC) treatment:
- In Part A, patients must be eligible to receive carboplatin + etoposide + atezolizumab
- In Part B, patients must be eligible to receive etoposide, carboplatin or cisplatin, and atezolizumab or durvalumab
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No prior systemic treatment for ES-SCLC
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Prior systematic anti-cancer treatment for limited-stage small cell lung cancer (SCLC) must have been complete at least 6 months prior to the diagnosis of ES-SCLC
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Further inclusion criteria apply.
- Previous treatment in this trial
- Treatment with a systemic anti-cancer therapy or investigational drug within 28 days or 5 half-lives (whichever is longer) of the first administration of trial medication
- Presence of leptomeningeal carcinomatosis
- Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers and cell therapies
- Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532
- 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)
- 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
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to Screening (other than the target indication), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab BI 764532 - Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab Etoposide - Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab Cisplatin - Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab Carboplatin - Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab Etoposide - Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab Durvalumab - Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab Etoposide - Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab Atezolizumab - Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab BI 764532 - Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab Carboplatin - Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab Etoposide - Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab Atezolizumab - Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab BI 764532 - Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab Etoposide - Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab Atezolizumab - Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab BI 764532 - Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab Carboplatin - Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab Etoposide - Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab Atezolizumab - Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab Carboplatin - Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab Etoposide - Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab Atezolizumab - Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab BI 764532 - Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab Carboplatin - Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab BI 764532 - Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab BI 764532 - Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab Carboplatin - Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab Durvalumab -
- Primary Outcome Measures
Name Time Method Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period up to 6 weeks Part B - Dose expansion: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period up to 23 months
- Secondary Outcome Measures
Name Time Method Part A - Dose escalation: Occurrence of adverse events (AEs) during the on-treatment period up to 23 months Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period up to 23 months Part B - Dose expansion: Objective response (OR) up to 23 months OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator's 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 B - Dose expansion: Duration of response (DoR) up to 23 months DoR is defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response
Related Research Topics
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Trial Locations
- Locations (21)
Orlando Health Cancer Institute
🇺🇸Orlando, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
Kortrijk - HOSP AZ Groeninge Kennedylaan
🇧🇪Kortrijk, Belgium
INS Bergonie
🇫🇷Bordeaux, France
HOP Louis Pradel
🇫🇷Bron, France
HOP Civil
🇫🇷Strasbourg, France
INS Gustave Roussy
🇫🇷Villejuif, France
Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Gießen, Germany
Saitama Medical University International Medical Center
🇯🇵Saitama, Hidaka, Japan
Hamamatsu University Hospital
🇯🇵Shizuoka, Hamamatsu, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Chuo-ku, Japan
Japanese Foundation for Cancer Research
🇯🇵Tokyo, Koto-ku, Japan
Medical University Gdansk
🇵🇱Gdansk, Poland
Polish Mother's Memorial Hospital - Research Institute
🇵🇱Lodz, Poland
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
🇵🇱Poznan, Poland
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
University Hospital of Lausanne
🇨🇭Lausanne, Switzerland