1438-0009 Dose Escalation & confirmation safety study of IV BI 764532 in combination with topotecan
Research type
Research Study
Full title
DAREONTM-9: A Phase Ib open-label dose escalation and dose confirmation safety study of intravenous BI 764532 in combination with topotecan for the treatment of patients with small cell lung cancer
IRAS ID
1008499
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Clinicaltrials.gov Identifier
Research summary
DAREONTM-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 topotecan
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 topotecan treatment. The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with topotecan. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and topotecan as infusions into a vein. As an alternative, topotecan may also be taken orally (tablets). 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.REC name
West of Scotland REC 1
REC reference
23/WS/0152
Date of REC Opinion
3 Nov 2023
REC opinion
Further Information Favourable Opinion