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

Study Identifier:
1438-0008
CT.gov Identifier:
NCT06077500
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-506008-20-00
Study Contact Information:
N/A
Recruitment Complete

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Study Summary

To evaluate in people with advanced cancer that are eligible for standard of care including chemotherapy and anti-PD-L1 (Programmed Cell Death Ligand 1) immunotherapy.

To investigate obrixtamig + first-line (1L) SoC (carboplatin + etoposide + atezolizumab) in patients (pts) with ES-SCLC.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Small Cell Lung
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab
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  • Drug: Experimental: Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab
  • Drug: Experimental: Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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.
    • inclusion criteria include confirmed ES-SCLC; no prior systemic treatment for 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
    • 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.
    • exclusion criteria include previous Tx with DLL3-targeting TcEs; persistent, unresolved toxicity from previous Txs; immunodeficiency, or systemic steroid or other immunosuppressive therapy ≤7 days prior to first dose of BI 764532; and significant cardio/cerebrovascular disease.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Manuel Domine
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Small Cell Lung