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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
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
Start Date
February 14, 2024
Primary Completion Date
September 1, 2026
Completion Date
September 1, 2026
Last Updated
January 6, 2026
45
ACTUAL participants
BI 764532
DRUG
Carboplatin
DRUG
Etoposide
DRUG
Atezolizumab
DRUG
Durvalumab
DRUG
Cisplatin
DRUG
Lead Sponsor
Boehringer Ingelheim
NCT05963867
NCT05879978
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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