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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 (DAREONᵀᴹ-8)

Primary Purpose

Small Cell Lung Carcinoma (SCLC)

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BI 764532
Carboplatin
Etoposide
Atezolizumab
Durvalumab
Cisplatin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma (SCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Current enrolment in another investigational device or drug trial, or <30 days since ending another investigational device or drug trial(s) 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 1 week 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

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

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

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

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

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

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

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

    Arm Description

    Outcomes

    Primary Outcome Measures

    Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
    Part B - Dose expansion: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period

    Secondary Outcome Measures

    Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period
    Part A - Dose escalation: Occurrence of adverse events (AEs) during the on-treatment period
    Part B - Dose expansion: Objective response (OR)
    OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator's assessment) from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent
    Part B - Dose expansion: Duration of response (DoR)
    DoR is defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response

    Full Information

    First Posted
    October 5, 2023
    Last Updated
    October 17, 2023
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06077500
    Brief Title
    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
    Acronym
    DAREONᵀᴹ-8
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 30, 2023 (Anticipated)
    Primary Completion Date
    August 20, 2025 (Anticipated)
    Study Completion Date
    June 25, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Small Cell Lung Carcinoma (SCLC)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab
    Arm Type
    Experimental
    Arm Title
    Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab
    Arm Type
    Experimental
    Arm Title
    Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab
    Arm Type
    Experimental
    Arm Title
    Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab
    Arm Type
    Experimental
    Arm Title
    Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab
    Arm Type
    Experimental
    Arm Title
    Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab
    Arm Type
    Experimental
    Arm Title
    Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    BI 764532
    Intervention Description
    BI 764532
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Intervention Description
    Carboplatin
    Intervention Type
    Drug
    Intervention Name(s)
    Etoposide
    Intervention Description
    Etoposide
    Intervention Type
    Drug
    Intervention Name(s)
    Atezolizumab
    Intervention Description
    Atezolizumab
    Intervention Type
    Drug
    Intervention Name(s)
    Durvalumab
    Intervention Description
    Durvalumab
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Intervention Description
    Cisplatin
    Primary Outcome Measure Information:
    Title
    Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
    Time Frame
    up to 6 weeks
    Title
    Part B - Dose expansion: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period
    Time Frame
    up to 23 months
    Secondary Outcome Measure Information:
    Title
    Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period
    Time Frame
    up to 23 months
    Title
    Part A - Dose escalation: Occurrence of adverse events (AEs) during the on-treatment period
    Time Frame
    up to 23 months
    Title
    Part B - Dose expansion: Objective response (OR)
    Description
    OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator's assessment) from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent
    Time Frame
    up to 23 months
    Title
    Part B - Dose expansion: Duration of response (DoR)
    Description
    DoR is defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response
    Time Frame
    up to 23 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 Current enrolment in another investigational device or drug trial, or <30 days since ending another investigational device or drug trial(s) 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 1 week 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Boehringer Ingelheim
    Phone
    1-800-243-0127
    Email
    clintriage.rdg@boehringer-ingelheim.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.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.
    IPD Sharing 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.
    IPD Sharing 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.
    IPD Sharing URL
    https://www.mystudywindow.com/msw/datasharing
    Links:
    URL
    https://www.mystudywindow.com
    Description
    Related Info

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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

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