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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
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 had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment. 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.
Official title: DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With a Single Agent Chemotherapy for the Treatment of Patients With Relapsed/Refractory Small Cell Lung Cancer After Platinum-based Chemotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2024-02-14
Completion Date
2027-07-30
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
BI 764532
BI 764532
Topotecan
Topotecan
Single agent chemotherapy
single agent chemotherapy
Locations (14)
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
Virginia Commonwealth University
Richmond, Virginia, United States
INS Curie
Paris, France
HOP Civil
Strasbourg, France
Institut 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