DAREON??-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
18 Years and older, Male and Female
1438-0008 (primary)
NCI-2024-04226
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 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
- Male or female participants =18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF)
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Histologically or cytologically confirmed extensive-stage small cell lung carcinoma (ES-SCLC)
- Availability of archival tumour tissue
- Patients must be eligible for platinum+etoposide+anti-Programmed Cell Death Ligand 1 (PD-L1) regimen as first line standard of care (SoC) treatment:
- In Part A, patients must be eligible to receive carboplatin + etoposide + atezolizumab
- In Part B, patients must be eligible to receive etoposide, carboplatin or cisplatin, and atezolizumab or durvalumab
- No prior systemic treatment for ES-SCLC
- Prior systematic anti-cancer treatment for limited-stage small cell lung cancer (SCLC) must have been complete at least 6 months prior to the diagnosis of ES-SCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Further inclusion criteria apply.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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