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Clinical Trials in France / NCT06077500
Active, not recruiting Phase 1

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

NCT06077500 · tracked via the Priya Life Science France tracker
Phase
Phase 1
Started
2024-02-14
Last updated
2026-09-30

Condition(s) studied

Small Cell Lung Carcinoma (SCLC)

Investigational drug(s) / intervention(s)

BI 764532 →Carboplatin →Etoposide →Atezolizumab →

BI 764532: BI 764532

Carboplatin: Carboplatin

Etoposide: Etoposide

Atezolizumab: Atezolizumab

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) * Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * Histologically or cytologically confirmed extensive-stage small cell lung carcinoma (ES-SCLC) * Availability of archival tumour tissue * Patients must be eligible for platinum+etoposide+anti-Programmed Cell Death Ligand 1 (PD-L1) regimen as first line standard of care (SoC) treatment: * In Part A, patients must be eligible to receive carboplatin + etoposide + atezolizumab * In Part B, patients must be eligible to receive etoposide, carboplatin or cisplatin, and atezolizumab or durvalumab * No prior systemic treatment for ES-SCLC * Prior systematic anti-cancer treatment for limited-stage small cell lung cancer (SCLC) must have been complete at least 6 months prior to the diagnosis of ES-SCLC * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Further inclusion criteria apply. Exclusion Criteria: * Previous treatment in this trial * Treatment with a systemic anti-cancer therapy or investigational drug within 28 days or 5 half-lives (whichever is longer) of the first administration of trial medication * Presence of leptomeningeal carcinomatosis * Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers and cell therapies * Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532 * Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlled by replacement therapy) * Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement * Any documented active or suspected malignancy or history of malignancy within 5 years prior to Screening (other than the target indication), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Orlando Health Cancer Institute Orlando Florida
Emory University Atlanta Georgia
Cliniques Universitaires Saint-Luc Brussels Belgium
AZ Groeninge Kortrijk Belgium
INS Bergonie Bordeaux France
Hopital 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 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

On this site

📄 Tecentriq (atezolizumab) drug profile →

More Boehringer Ingelheim trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06077500 on ClinicalTrials.gov ↗ ← All trials in France