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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
BI 764532
Carboplatin
Etoposide
Atezolizumab
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
Hopital 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
...and 11 more locations
Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Time frame: up to 6 weeks
Part B - Dose expansion: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period
Time frame: up to 23 months
Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period
Time frame: up to 23 months
Part A - Dose escalation: Occurrence of adverse events (AEs) during the on-treatment period
Time frame: up to 23 months
Part B - Dose expansion: Objective response (OR)
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
Time frame: up to 23 months
Part B - Dose expansion: Duration of response (DoR)
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
Time frame: up to 23 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.