Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Small Cell Lung Carcinoma and Neuroendocrine Neoplasms, sponsored by Boehringer Ingelheim.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
according to RECIST v 1.1 by investigator assessment from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2023-10-13 |
| Est. Completion | 2028-02-24 |
| Phase | Phase 2 |
What NCT05882058 shows while recruiting
NCT05882058 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 251-participant average among 18 other Small Cell Lung Carcinoma trials with a reported enrollment target (31% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Small Cell Lung Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05882058's enrollment target sits among peer trials
174 7th of 18 higher than 12 of 18 other Small Cell Lung Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small Cell Lung Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
RECRUITING · Phase 2
-
A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain
RECRUITING · Phase 2
-
A Study of Hospital-at-Home for People Receiving Tarlatamab
RECRUITING · NA
-
Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer
RECRUITING · Early Phase 1
-
A Study of LY4175408 in Participants With Advanced Cancer
RECRUITING · Phase 1
-
PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01000259 · 174 participants
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
- NCT04729114 · 174 participants · Phase 1
A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
- NCT04884035 · 174 participants · Phase 1
Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
- NCT05075980 · 174 participants · Phase 2
Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI