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A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
NCT04429087 · View on ClinicalTrials.gov ↗
Study Summary
This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). 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 out the highest dose of BI 764532 and the best treatment schedule that people can tolerate. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. In this study, BI 764532 is given to people for the first time. That means no clinical data are available for BI 764532. Participants get BI 764532 either weekly or once every 3 weeks. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about 20 times depending on the response to the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
Conditions Studied
Interventions
- DRUG BI 764532 - parenteral 1
- DRUG BI 764532 - parenteral 2
Study Locations (12)
Other
- Universitätsklinikum Köln (AöR) — Cologne
- Technische Universität Dresden — Dresden
- Universitätsklinikum Würzburg AÖR — Würzburg
- National Cancer Center Hospital East — Chiba, Kashiwa
- Hospital del Mar — Barcelona
- Hospital Universitari Vall D Hebron — Barcelona
- Clínica Universidad de Navarra — Pamplona
- Hospital Clinico Universitario De Valencia — Valencia
Georgia
- Winship Cancer Institute — Atlanta
Maryland
- University of Maryland School of Medicine — Baltimore
Missouri
- Washington University School of Medicine — St Louis
Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2027-02-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04429087
The ClinicalTrials.gov registry entry for NCT04429087 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Patients With Small Cell Lung Carcinoma and Other Neoplasms appearing as the primary indexed condition, and to 2 interventions — of which BI 764532 - parenteral 1 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04429087 reports 12 study locations spanning 5 distinct geographic areas — top geographies include Other, Georgia, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04429087 about?
NCT04429087 is a clinical study titled "A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3". This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this stud...
What is the current status of trial NCT04429087?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2020-07-29. Estimated completion is 2027-02-15.
What conditions does trial NCT04429087 study?
This clinical trial studies the following conditions: Patients With Small Cell Lung Carcinoma and Other Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04429087?
The interventions under investigation include: BI 764532 - parenteral 1 (DRUG), BI 764532 - parenteral 2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04429087?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04429087 being conducted?
This trial has 12 study locations across Georgia, Maryland, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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