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NCT05882058 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Small Cell Lung Carcinoma and Neuroendocrine Neoplasms, sponsored by Boehringer Ingelheim.

Recruiting
Registry status
Phase 2
Development phase
174
Enrollment target
20
Study locations

NCT05882058 is a Phase 2 study of Small Cell Lung Carcinoma and Neuroendocrine Neoplasms that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 174 participants, below the 251-participant average among 18 other Small Cell Lung Carcinoma trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT05882058, a Phase 2 study of Small Cell Lung Carcinoma and Neuroendocrine Neoplasms, is actively recruiting participants, sponsored by Boehringer Ingelheim.

RECRUITING
Registry status
Phase 2
Development phase
174 participants
Enrollment target
20
Study locations

Study Summary

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 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 2 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, all participants receive the same dose of BI 764532. Part 2 is 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.

Conditions Studied

Small Cell Lung Carcinoma Neuroendocrine Neoplasms Extra-pulmonary Neuroendocrine Carcinoma

Interventions

  • DRUG BI 764532, dose 1
  • DRUG BI 764532, dose 2

Study Locations (20)

Other

  • Universitair Ziekenhuis Gent - Ghent
  • UZ Leuven - Leuven
  • MHAT UniHospital - Panagyurishte
  • MHAT Heart and brain - Pleven

Florida

  • Mayo Clinic Cancer Center - Jacksonville
  • University of Miami - Miami
  • H. Lee Moffitt Cancer Center and Research Institute - Tampa

California

  • Valkyrie Clinical Trials - Los Angeles
  • University of California San Francisco - San Francisco

New York

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health - New York
  • Montefiore Medical Center - The Bronx

Alabama

  • Infirmary Cancer Care - Mobile

Arizona

  • Mayo Clinic-Arizona - Phoenix

Indiana

  • Indiana University - Indianapolis

Kansas

  • University of Kansas Cancer Center - Westwood

Trial Details

FieldValue
Enrollment Target 174 participants
Start Date 2023-10-13
Est. Completion 2028-02-24
Phase Phase 2

Sponsor

Boehringer Ingelheim

515 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05882058

The ClinicalTrials.gov registry entry for NCT05882058 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 251-participant average among 18 other Small Cell Lung Carcinoma trials with a reported enrollment target (31% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Small Cell Lung Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which BI 764532, dose 1 is the first listed.

NCT05882058 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Florida, California.

Frequently Asked Questions

What is clinical trial NCT05882058 about?

NCT05882058 is a clinical study titled "DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers". 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 that people with a...

What is the current status of trial NCT05882058?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 174 participants. The study started on 2023-10-13. Estimated completion is 2028-02-24.

What conditions does trial NCT05882058 study?

This clinical trial studies the following conditions: Small Cell Lung Carcinoma, Neuroendocrine Neoplasms, Extra-pulmonary Neuroendocrine Carcinoma.

What interventions are being tested in trial NCT05882058?

The interventions under investigation include: BI 764532, dose 1 (DRUG), BI 764532, dose 2 (DRUG).

Who is sponsoring clinical trial NCT05882058?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05882058 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.