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Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Primary Purpose

Leptomeningeal Metastasis, Durvalumab

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Durvalumab
methotrexate
Sponsored by
Hui Bu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leptomeningeal Metastasis focused on measuring Leptomeningeal Metastasis, Durvalumab, Intrathecal chemotherapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Male and Female age 18 or more
  2. Pathologically proven non-small cell lung cancer
  3. MRI(Magnetic Resonance Imaging,MRI) imaging findings or the detection of malignant cells in cerebrospinal fluid
  4. Patients have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. KPS score <60
  2. History of autoimmune diseases
  3. With severe hepatic and renal dysfunction
  4. Has a history of (non-infectious) pneumonitis that required steroids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Leptomeningeal Metastasis

    Arm Description

    Durvalumab + Intrathecal chemotherapy

    Outcomes

    Primary Outcome Measures

    overall survival (OS)
    OS was defined as the time between the start of treatment to the date of death or date participant was last known to be alive
    Neurological Progression Free Survival(NPFS)
    NPFS was defined as the time between the start of treatment until central nervous system metastase progression or death due to any cause
    The incidence of adverse reactions
    In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks

    Secondary Outcome Measures

    Progression Free Survival(PFS)
    NPFS was defined as the time between the start of treatment to the date of the first documented tumor progression as determined by investigators per RECIST 1.1,or death due to any cause
    Objective response rate (ORR)
    Investigator assessed ORR was defined as the number of subjects whose best objective response (OOR) was a confirmed complete response (CR) or confirmed partial response (PR)
    Neurological assessment
    In accordance with the standard of Response Assessment in Neuro-Oncology(RANO) Neurological Assessment group.The maximum value is 29 and the minimum value is 0.The higher scores mean a worse outcome.

    Full Information

    First Posted
    April 18, 2020
    Last Updated
    May 22, 2020
    Sponsor
    Hui Bu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04356222
    Brief Title
    Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
    Official Title
    Efficacy and Safety of Durvalumab Combined With Intrathecal Chemotherapy in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2020 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hui Bu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to observe the clinical efficacy and safety of Durvalumab combined with intrathecal chemotherapy in non-small cell lung cancer with leptomeningeal metastasis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leptomeningeal Metastasis, Durvalumab
    Keywords
    Leptomeningeal Metastasis, Durvalumab, Intrathecal chemotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Leptomeningeal Metastasis
    Arm Type
    Experimental
    Arm Description
    Durvalumab + Intrathecal chemotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    Durvalumab
    Intervention Description
    Intravenous infusion once every two weeks ,once 10mg/kg.
    Intervention Type
    Drug
    Intervention Name(s)
    methotrexate
    Intervention Description
    Intrathecal chemotherapy specified dose on specified days
    Primary Outcome Measure Information:
    Title
    overall survival (OS)
    Description
    OS was defined as the time between the start of treatment to the date of death or date participant was last known to be alive
    Time Frame
    36 months
    Title
    Neurological Progression Free Survival(NPFS)
    Description
    NPFS was defined as the time between the start of treatment until central nervous system metastase progression or death due to any cause
    Time Frame
    36 months
    Title
    The incidence of adverse reactions
    Description
    In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks
    Time Frame
    36 months
    Secondary Outcome Measure Information:
    Title
    Progression Free Survival(PFS)
    Description
    NPFS was defined as the time between the start of treatment to the date of the first documented tumor progression as determined by investigators per RECIST 1.1,or death due to any cause
    Time Frame
    36 months
    Title
    Objective response rate (ORR)
    Description
    Investigator assessed ORR was defined as the number of subjects whose best objective response (OOR) was a confirmed complete response (CR) or confirmed partial response (PR)
    Time Frame
    36 months
    Title
    Neurological assessment
    Description
    In accordance with the standard of Response Assessment in Neuro-Oncology(RANO) Neurological Assessment group.The maximum value is 29 and the minimum value is 0.The higher scores mean a worse outcome.
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and Female age 18 or more Pathologically proven non-small cell lung cancer MRI(Magnetic Resonance Imaging,MRI) imaging findings or the detection of malignant cells in cerebrospinal fluid Patients have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: KPS score <60 History of autoimmune diseases With severe hepatic and renal dysfunction Has a history of (non-infectious) pneumonitis that required steroids
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hui Bu
    Phone
    86-13831106903
    Email
    buhuimy1@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hui Bu
    Organizational Affiliation
    The Second Hospital of Hebei Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

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