🏛️ Verified NIH Record • Updated 2026-07-22

DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers (NCT05882058)

DAREON™-5: An Open-label, Multi-center Phase II Dose Selection Trial of Intravenous BI 764532, a DLL3-targeting T Cell Engager, in Patients With Relapsed/Refractory Extensive-stage Small Cell Lung Cancer and in Patients With Other Relapsed/Refractory Neuroendocrine Carcinomas

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Boehringer Ingelheim

🩺 Plain-English Summary (8th-Grade Level)

This study is open to adults with small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find a suitable dose of BI 764532 (also called obrixtamig) that people with advanced cancer can tolerate. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. The study has 3 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2 and Part 3, all participants receive the same dose of BI 764532. Part 2 and Part 3 are open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma. All participants receive BI 764532 as an infusion into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include an overnight stay to monitor participants´ safety. Doctors record any unwanted effects and regularly check the general health of the participants.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (13 items).

Location: Infirmary Cancer Care — Mobile, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check 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:
  • Untreated or symptomatic brain metastases. (Part 2 and part 3: identified during the mandatory assessment by brain MRI within 21 days before first trial drug administration.) Participants with treated, stable brain metastases are eligible provided they meet the following criteria:
  • Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532.
  • Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant central nervous system (CNS) disease.
  • Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression.
  • Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade). Part 2 and part 3: Active/previous history of interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade). Patients with a history of therapy-related pneumonitis that is considered clinically resolved are eligible.
  • Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
  • Prior anti-cancer therapy:
  • Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.
  • Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532.
  • Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies.
  • Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (59 Sites)

Showing the first 25 of 59 sites.

  • Infirmary Cancer Care — Mobile, Alabama
  • Mayo Clinic-Arizona — Phoenix, Arizona
  • Valkyrie Clinical Trials — Los Angeles, California
  • University of California San Francisco — San Francisco, California
  • Mayo Clinic Cancer Center — Jacksonville, Florida
  • University of Miami — Miami, Florida
  • H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
  • Indiana University — Indianapolis, Indiana
  • University of Kansas Cancer Center — Westwood, Kansas
  • University of Kentucky Medical Center — Lexington, Kentucky
  • University of Maryland School of Medicine — Baltimore, Maryland
  • Dana-Farber Cancer Institute — Boston, Massachusetts
  • Mayo Clinic, Rochester — Rochester, Minnesota
  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York
  • Montefiore Medical Center — The Bronx, New York
  • Virginia Commonwealth University Health- Adult Outpatient Pavilion — Richmond, Virginia
  • Universitair Ziekenhuis Gent — Ghent,
  • UZ Leuven — Leuven,
  • Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. — Panagyurishte,
  • MHAT Heart and brain — Pleven,
  • West China Hospital, Sichuan University — Chengdu,
  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine — Hangzhou,
  • Qilu Hospital, Shangdong University — Jinan,
  • 960 Hospital of the Chinese People's Liberation Army — Jinan,
  • The Second Affiliated Hospital to Nanchang University — Nanchang,

📞 Contact the Study Coordinator

Phone: (800) 243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗