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ACTIVE NOT RECRUITING 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

NCT05990738 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 69 participants
Start Date 2024-02-14
Est. Completion 2027-07-30
Phase Phase 1

Sponsor

Boehringer Ingelheim

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05990738

The ClinicalTrials.gov registry entry for NCT05990738 describes a study currently listed as active not 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 69 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 Small Cell Lung Carcinoma (SCLC) appearing as the primary indexed condition, and to 3 interventions — of which Topotecan 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: NCT05990738 reports 14 study locations spanning 4 distinct geographic areas — top geographies include Other, Florida, District of Columbia. 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 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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05990738?

The interventions under investigation include: Topotecan (DRUG), BI 764532 (DRUG), Single agent chemotherapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05990738?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial