DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
BI 764532: BI 764532
Carboplatin: Carboplatin
Etoposide: Etoposide
Atezolizumab: Atezolizumab
Study summary
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.
Eligibility
Primary outcome measure(s)
- Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period — up to 6 weeks
- Part B - Dose expansion: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period — up to 23 months
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Orlando Health Cancer Institute | Orlando | Florida | |
| Emory University | Atlanta | Georgia | |
| 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 | |
| Hamamatsu University Hospital | Shizuoka, Hamamatsu | Japan | |
| National Cancer Center Hospital | Tokyo, Chuo-ku | Japan | |
| Japanese Foundation for Cancer Research | Tokyo, Koto-ku | Japan | |
| Medical University Gdansk | Gdansk | Poland | |
| Polish Mother's Memorial Hospital - Research Institute | Lodz | Poland | |
| Med Polonia Sp. z o.o | Poznan | Poland | |
| Hospital Universitario Ramon Y Cajal | Madrid | Spain | |
| Fundación Jiménez Díaz | Madrid | Spain | |
| Hospital Universitario Virgen De La Macarena | Seville | Spain | |
| Instituto Valenciano de Oncología | Valencia | Spain | |
| University Hospital of Lausanne | Lausanne | Switzerland |
On this site
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06077500 on ClinicalTrials.gov ↗ ← All trials in Spain