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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

NCT ID: NCT06077500

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2026-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Small Cell Lung Carcinoma (SCLC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Carboplatin

Intervention Type DRUG

Carboplatin

Etoposide

Intervention Type DRUG

Etoposide

Atezolizumab

Intervention Type DRUG

Atezolizumab

Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Carboplatin

Intervention Type DRUG

Carboplatin

Etoposide

Intervention Type DRUG

Etoposide

Atezolizumab

Intervention Type DRUG

Atezolizumab

Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Carboplatin

Intervention Type DRUG

Carboplatin

Etoposide

Intervention Type DRUG

Etoposide

Atezolizumab

Intervention Type DRUG

Atezolizumab

Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Carboplatin

Intervention Type DRUG

Carboplatin

Etoposide

Intervention Type DRUG

Etoposide

Atezolizumab

Intervention Type DRUG

Atezolizumab

Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Carboplatin

Intervention Type DRUG

Carboplatin

Etoposide

Intervention Type DRUG

Etoposide

Atezolizumab

Intervention Type DRUG

Atezolizumab

Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Carboplatin

Intervention Type DRUG

Carboplatin

Etoposide

Intervention Type DRUG

Etoposide

Durvalumab

Intervention Type DRUG

Durvalumab

Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab

Group Type EXPERIMENTAL

BI 764532

Intervention Type DRUG

BI 764532

Etoposide

Intervention Type DRUG

Etoposide

Durvalumab

Intervention Type DRUG

Durvalumab

Cisplatin

Intervention Type DRUG

Cisplatin

Interventions

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BI 764532

BI 764532

Intervention Type DRUG

Carboplatin

Carboplatin

Intervention Type DRUG

Etoposide

Etoposide

Intervention Type DRUG

Atezolizumab

Atezolizumab

Intervention Type DRUG

Durvalumab

Durvalumab

Intervention Type DRUG

Cisplatin

Cisplatin

Intervention Type DRUG

Other Intervention Names

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Obrixtamig

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orlando Health Cancer Institute

Orlando, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

AZ Groeninge

Kortrijk, , Belgium

Site Status

INS Bergonie

Bordeaux, , France

Site Status

HOP Louis Pradel

Bron, , France

Site Status

HOP Civil

Strasbourg, , France

Site Status

INS Gustave Roussy

Villejuif, , France

Site Status

Universitätsklinikum Gießen und Marburg GmbH

Giessen, , Germany

Site Status

Saitama Medical University International Medical Center

Saitama, Hidaka, , Japan

Site Status

Hamamatsu University Hospital

Shizuoka, Hamamatsu, , Japan

Site Status

National Cancer Center Hospital

Tokyo, Chuo-ku, , Japan

Site Status

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, , Japan

Site Status

Medical University Gdansk

Gdansk, , Poland

Site Status

Polish Mother's Memorial Hospital - Research Institute

Lodz, , Poland

Site Status

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

Poznan, , Poland

Site Status

Hospital Universitario Ramon Y Cajal

Madrid, , Spain

Site Status

Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Universitario Virgen De La Macarena

Seville, , Spain

Site Status

Instituto Valenciano de Oncología

Valencia, , Spain

Site Status

University Hospital of Lausanne

Lausanne, , Switzerland

Site Status

Countries

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United States Belgium France Germany Japan Poland Spain Switzerland

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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1438-0008

Identifier Type: -

Identifier Source: org_study_id