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ACTIVE NOT RECRUITING
NCT06077500
PHASE1

DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer

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 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2024-02-14

Completion Date

2026-09-01

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

BI 764532

BI 764532

DRUG

Carboplatin

Carboplatin

DRUG

Etoposide

Etoposide

DRUG

Atezolizumab

Atezolizumab

Locations (21)

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

Hamamatsu University Hospital

Shizuoka, Hamamatsu, Japan

National Cancer Center Hospital

Tokyo, Chuo-ku, Japan

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, Japan

Medical University Gdansk

Gdansk, Poland

Polish Mother's Memorial Hospital - Research Institute

Lodz, Poland

MED POLONIA SP Z O O, Clinical Trials Department,Poznan

Poznan, Poland

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario Virgen De La Macarena

Seville, Spain

Instituto Valenciano de Oncología

Valencia, Spain

University Hospital of Lausanne

Lausanne, Switzerland