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Active, not recruiting Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT05990738

Public ClinicalTrials.gov record NCT05990738. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 9:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With a Single Agent Chemotherapy for the Treatment of Patients With Relapsed/Refractory Small Cell Lung Cancer After Platinum-based Chemotherapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05990738
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
69 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 13, 2024
Primary completion
Mar 29, 2027
Completion
Apr 29, 2027
Last update posted
Aug 3, 2026

2024 – 2027

United States locations

U.S. sites
4
U.S. states
3
U.S. cities
4
Facility City State ZIP Site status
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007
Mayo Clinic - Florida Jacksonville Florida 32224
University of Miami Miami Florida 33136
Virginia Commonwealth University Richmond Virginia 23219

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05990738, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 3, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05990738 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →