DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care… (NCT06077500) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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
United States, Belgium, France46 participantsStarted 2024-02-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Previous treatment in this trial
* Treatment with a systemic anti-cancer therapy or investigational drug within 28 days or 5 half-lives (whichever is longer) of the first administration of trial medication
* Presence of leptomeningeal carcinomatosis
* Previous t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the right dose of BI 764532 and measuring dose-limiting toxicities, what does that mean for how much is known so far about whether this drug actually shrinks tumors in small cell lung cancer?
2This trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — does that close the door entirely, or are there related trials studying BI 764532 that I might still be eligible for?
3Because the trial is combining BI 764532 with standard of care treatment, how would my doctor monitor for side effects from both at once, and are the toxicity risks expected to be higher than standard of care alone?
4Given that this is a dose-escalation and dose-expansion study, different participants may have received very different doses — what does my doctor know so far about which dose levels have shown serious safety signals in SCLC patients?
5Before considering an experimental Phase 1 add-on like this, should I first ask whether completing standard of care treatment on its own might be a better starting path for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Timeframe: up to 6 weeks
2
Part B - Dose expansion: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period