🏛️ 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: Review the eligibility criteria below.

Location: Infirmary Cancer Care — Mobile, Alabama

Age range: 18 Years

🧪 Interventions in This Study

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

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 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 ↗