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 (NCT06077500)
DAREONᵀᴹ-8: A Phase I, Open-label, Dose Escalation and Expansion Trial of Repeated Intravenous Infusions of BI 764532 Combined With Standard of Care (Platinium, Etoposide, and Anti-PD-L1) in Patients With Extensive-stage Small Cell Lung Carcinoma
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (9 items).
Location: Orlando Health Cancer Institute — Orlando, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following 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 treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers and cell therapies
- Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532
- Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlled by replacement therapy)
- Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to Screening (other than the target indication), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (21 Sites)
- Orlando Health Cancer Institute — Orlando, Florida
- Emory University — Atlanta, Georgia
- Cliniques Universitaires Saint-Luc — Brussels,
- AZ Groeninge — Kortrijk,
- INS Bergonie — Bordeaux,
- Hôpital Louis Pradel — Bron,
- HOP Civil — Strasbourg,
- Institut Gustave Roussy — Villejuif,
- Universitätsklinikum Gießen und Marburg GmbH — Giessen,
- Saitama Medical University International Medical Center — Saitama, Hidaka,
- Hamamatsu University Hospital — Shizuoka, Hamamatsu,
- National Cancer Center Hospital — Tokyo, Chuo-ku,
- Japanese Foundation for Cancer Research — Tokyo, Koto-ku,
- Medical University Gdansk — Gdansk,
- Polish Mother's Memorial Hospital - Research Institute — Lodz,
- MED POLONIA SP Z O O, Clinical Trials Department,Poznan — Poznan,
- Hospital Universitario Ramon Y Cajal — Madrid,
- Fundación Jiménez Díaz — Madrid,
- Hospital Universitario Virgen De La Macarena — Seville,
- Instituto Valenciano de Oncología — Valencia,
- University Hospital of Lausanne — Lausanne,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.