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
DAREONᵀᴹ-8
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
1 other identifier
interventional
46
8 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2024
Typical duration for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedStudy Start
First participant enrolled
February 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 14, 2026
April 1, 2026
2.5 years
October 5, 2023
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 (4)
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
Study Arms (5)
Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab
EXPERIMENTALPart A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab
EXPERIMENTALPart A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab
EXPERIMENTALPart A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab
EXPERIMENTALPart B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab
EXPERIMENTALInterventions
BI 764532
Carboplatin
Etoposide
Atezolizumab
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Emory University
Atlanta, Georgia, 30322, United States
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
INS Bergonie
Bordeaux, 33000, France
Hôpital Louis Pradel
Bron, 69677, France
HOP Civil
Strasbourg, 67091, France
Institut Gustave Roussy
Villejuif, 94805, France
Universitätsklinikum Gießen und Marburg GmbH
Giessen, 35392, Germany
Saitama Medical University International Medical Center
Saitama, Hidaka, 350-1298, Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045, Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550, Japan
Medical University Gdansk
Gdansk, 80-214, Poland
Polish Mother's Memorial Hospital - Research Institute
Lodz, 93-338, Poland
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
Poznan, 60-693, Poland
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario Virgen De La Macarena
Seville, 41009, Spain
Instituto Valenciano de Oncología
Valencia, 46009, Spain
University Hospital of Lausanne
Lausanne, 1011, Switzerland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2023
First Posted
October 11, 2023
Study Start
February 14, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.