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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
BI 764532
Topotecan
single agent chemotherapy
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
...and 4 more locations
Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Time frame: up to 9 weeks
Part B: Occurrence of DLTs during the on-treatment period
Time frame: up to 36 months
Part B: Occurrence of AEs during the on-treatment period
Time frame: up to 36 months
Part A: Occurrence of DLTs during the on-treatment period
Time frame: up to 36 months
Part A: Occurrence of AEs during the on-treatment period
Time frame: up to 36 months
Part B: Objective response
Time frame: up to 36 months
Part B: Duration of response
Time frame: up to 36 months
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