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NCT05990738 · ClinicalTrials.gov registry record · Phase 1
DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy
A Phase 1 study of Small Cell Lung Carcinoma (SCLC), sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
- 14
- Study locations
NCT05990738: Active Phase 1 study of Small Cell Lung Carcinoma (SCLC), sponsored by Boehringer Ingelheim.
NCT05990738 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 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). The trial reports 14 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05990738, 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
- 69 participants
- Enrollment target
- 14
- 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 had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment. The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. 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 Topotecan
- DRUG BI 764532
- DRUG Single agent chemotherapy
Study Locations (14)
Other
- INS Curie - Paris
- HOP Civil - Strasbourg
- Institut Gustave Roussy - Villejuif
- Universitätsklinikum Carl Gustav Carus Dresden - Dresden
- Universitätsklinikum Erlangen - Erlangen
- Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg - Heidelberg
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Mainz
- Universitätsklinikum Würzburg AÖR - Würzburg
- Polish Mother's Memorial Hospital - Research Institute - Lodz
- Leicester Royal Infirmary - Leicester
Florida
- Mayo Clinic - Florida - Jacksonville
- University of Miami - Miami
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2024-02-14 |
| Est. Completion | 2027-07-30 |
| Phase | Phase 1 |
What the registry record for NCT05990738 still lists
NCT05990738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 1 condition, with Small Cell Lung Carcinoma (SCLC) appearing as the primary indexed condition, and to 3 interventions - of which Topotecan is the first listed.
NCT05990738 lists 14 locations in 4 states (Other, Florida, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT05990738 about?
NCT05990738 is a clinical study titled "DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy". This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment. The purpose of this study is to find the highest dose of ...
What is the current status of trial NCT05990738?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2024-02-14. Estimated completion is 2027-07-30.
What conditions does trial NCT05990738 study?
This clinical trial studies the following conditions: Small Cell Lung Carcinoma (SCLC).
What interventions are being tested in trial NCT05990738?
The interventions under investigation include: Topotecan (DRUG), BI 764532 (DRUG), Single agent chemotherapy (DRUG).
Who is sponsoring clinical trial NCT05990738?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05990738 being conducted?
This trial has 14 study locations across District of Columbia, Florida, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05990738's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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