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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
Sponsor: Boehringer Ingelheim
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 (also called obrixtamig) 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.
Official title: DAREONᵀᴹ-8: A Phase I, Open-label, Dose Escalation and Expansion Trial of Repeated Intravenous Infusions of BI 764532 Combined With Standard of Care (Platinium, Etoposide, and Anti-PD-L1) in Patients With Extensive-stage Small Cell Lung Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2024-02-14
Completion Date
2026-09-01
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
BI 764532
BI 764532
Carboplatin
Carboplatin
Etoposide
Etoposide
Atezolizumab
Atezolizumab
Locations (21)
Orlando Health Cancer Institute
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Cliniques Universitaires Saint-Luc
Brussels, Belgium
AZ Groeninge
Kortrijk, Belgium
INS Bergonie
Bordeaux, France
Hôpital Louis Pradel
Bron, France
HOP Civil
Strasbourg, France
Institut 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 Universitario Ramon Y Cajal
Madrid, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario Virgen De La Macarena
Seville, Spain
Instituto Valenciano de Oncología
Valencia, Spain
University Hospital of Lausanne
Lausanne, Switzerland