Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05990738
PHASE1

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

69

Start Date

2024-02-14

Completion Date

2027-07-30

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

BI 764532

BI 764532

DRUG

Topotecan

Topotecan

DRUG

Single agent chemotherapy

single agent chemotherapy

Locations (14)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Mayo Clinic - Florida

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Virginia Commonwealth University

Richmond, Virginia, United States

INS Curie

Paris, France

HOP Civil

Strasbourg, France

Institut Gustave Roussy

Villejuif, France

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Universitätsklinikum Würzburg AÖR

Würzburg, Germany

Polish Mother's Memorial Hospital - Research Institute

Lodz, Poland

Leicester Royal Infirmary

Leicester, United Kingdom