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

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 69 participants

Interventions

• DRUG: BI 764532 — BI 764532
• DRUG: Topotecan — Topotecan
• DRUG: Single agent chemotherapy — single agent chemotherapy

Primary Outcomes

• Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period (up to 9 weeks)
• Part B: Occurrence of DLTs during the on-treatment period (up to 36 months)
• Part B: Occurrence of AEs during the on-treatment period (up to 36 months)

Secondary Outcomes

• Part A: Occurrence of DLTs during the on-treatment period (up to 36 months)
• Part A: Occurrence of AEs during the on-treatment period (up to 36 months)
• Part B: Objective response (up to 36 months)
• Part B: Duration of response (up to 36 months)

Trial Locations

• 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
• ...and 4 more locations

More Small Cell Lung Carcinoma (SCLC) Trials

View all Small Cell Lung Carcinoma (SCLC) clinical trials