DAREONᵀᴹ-8: A Phase I, Open-label, Dose Escalation and Expansion Trial of Repeated Intravenous Infusions of BI 764532 Combined With Standard of Care (Platinium, Etoposide, and Anti-PD-L1) in Patients With Extensive-stage Small Cell Lung Carcinoma

Official Summary

This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that are eligible for standard of care including chemotherapy and anti-PD-L1 (Programmed Cell Death Ligand 1) immunotherapy. The purpose of this study is to find out the highest dose of BI 764532 (also called obrixtamig) that people can tolerate when taken together with standard of care. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and different standard treatments as infusions into a vein. If there is benefit for the participants and if they can tolerate it, the treatment is given for the entire duration of the study. 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: 46 participants

Interventions

• DRUG: BI 764532 — BI 764532
• DRUG: Carboplatin — Carboplatin
• DRUG: Etoposide — Etoposide
• DRUG: Atezolizumab — Atezolizumab

Primary Outcomes

• Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period (up to 6 weeks)
• Part B - Dose expansion: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period (up to 23 months)

Secondary Outcomes

• Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period (up to 23 months)
• Part A - Dose escalation: Occurrence of adverse events (AEs) during the on-treatment period (up to 23 months)
• Part B - Dose expansion: Objective response (OR) (up to 23 months)
• Part B - Dose expansion: Duration of response (DoR) (up to 23 months)

Trial Locations

• Orlando Health Cancer Institute, Orlando, Florida, United States
• Emory University, Atlanta, Georgia, United States
• Cliniques Universitaires Saint-Luc, Brussels, Belgium
• AZ Groeninge, Kortrijk, Belgium
• INS Bergonie, Bordeaux, France
• Hôpital Louis Pradel, Bron, France
• HOP Civil, Strasbourg, France
• Institut Gustave Roussy, Villejuif, France
• Universitätsklinikum Gießen und Marburg GmbH, Giessen, Germany
• Saitama Medical University International Medical Center, Saitama, Hidaka, Japan
• ...and 10 more locations

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