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NCT06077500 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Small Cell Lung Carcinoma (SCLC), sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 20
- Study locations
NCT06077500 is a Phase 1 study of Small Cell Lung Carcinoma (SCLC) that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 45 participants. The trial reports 20 study locations across 3 states.
The verdict
NCT06077500, a Phase 1 study of Small Cell Lung Carcinoma (SCLC), is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Atezolizumab
- DRUG Etoposide
- DRUG Durvalumab
- DRUG BI 764532
Study Locations (20)
Other
- Cliniques Universitaires Saint-Luc - Brussels
- AZ Groeninge - Kortrijk
- INS Bergonie - Bordeaux
- HOP Louis Pradel - Bron
- HOP Civil - Strasbourg
- INS 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
Florida
- Orlando Health Cancer Institute - Orlando
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2024-02-14 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06077500
The ClinicalTrials.gov registry entry for NCT06077500 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Small Cell Lung Carcinoma (SCLC) appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT06077500 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Other, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT06077500 about?
NCT06077500 is a clinical study titled "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". 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 dos...
What is the current status of trial NCT06077500?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2024-02-14. Estimated completion is 2026-09-01.
What conditions does trial NCT06077500 study?
This clinical trial studies the following conditions: Small Cell Lung Carcinoma (SCLC).
What interventions are being tested in trial NCT06077500?
The interventions under investigation include: Carboplatin (DRUG), Atezolizumab (DRUG), Etoposide (DRUG), Durvalumab (DRUG), BI 764532 (DRUG).
Who is sponsoring clinical trial NCT06077500?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06077500 being conducted?
This trial has 20 study locations across Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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