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Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

Primary Purpose

Non-Small Cell Lung Cancer, Brain Metastases

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Icotinib
WBRT or SRS
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring NSCLC brain metastases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological or cytological confirmation of non-small-cell lung cancer (NSCLC) with brain metastases
  • Histological or cytological confirmation of EGRF positive sensitive mutation
  • Diagnosis of brain metastases on a Gadolinium-enhanced MRI

Exclusion Criteria:

  • Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux
  • Previous usage of radiation with brain
  • CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Icotinib

    Icotinib plus radiation therapy

    Arm Description

    icotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(>3 with WBRT or <=3 with SRS) after PD

    Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(>3), or SRS(<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses.

    Outcomes

    Primary Outcome Measures

    Progression-free survival of intracranial lesions
    Number of participants with progress of intracranial lesions

    Secondary Outcome Measures

    Progression-free survival
    Number of participants with progress of any places in body
    Objective response rate of intracranial lesions
    Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response

    Full Information

    First Posted
    October 31, 2018
    Last Updated
    November 26, 2018
    Sponsor
    Betta Pharmaceuticals Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03754530
    Brief Title
    Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
    Official Title
    A Multi-center, Open Label Study to Determine the Timelines and Effeciency of Icotinib in Combination With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2018 (Anticipated)
    Primary Completion Date
    June 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Betta Pharmaceuticals Co., Ltd.

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of intracranial lesions
    Detailed Description
    Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Small Cell Lung Cancer, Brain Metastases
    Keywords
    NSCLC brain metastases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    162 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Icotinib
    Arm Type
    Experimental
    Arm Description
    icotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(>3 with WBRT or <=3 with SRS) after PD
    Arm Title
    Icotinib plus radiation therapy
    Arm Type
    Experimental
    Arm Description
    Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(>3), or SRS(<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses.
    Intervention Type
    Drug
    Intervention Name(s)
    Icotinib
    Other Intervention Name(s)
    WBRT or SRS
    Intervention Description
    orally three times per day
    Intervention Type
    Radiation
    Intervention Name(s)
    WBRT or SRS
    Other Intervention Name(s)
    Icotinib
    Intervention Description
    >3 with WBRT;<=3 with SRS
    Primary Outcome Measure Information:
    Title
    Progression-free survival of intracranial lesions
    Description
    Number of participants with progress of intracranial lesions
    Time Frame
    10 months
    Secondary Outcome Measure Information:
    Title
    Progression-free survival
    Description
    Number of participants with progress of any places in body
    Time Frame
    8 months
    Title
    Objective response rate of intracranial lesions
    Description
    Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histological or cytological confirmation of non-small-cell lung cancer (NSCLC) with brain metastases Histological or cytological confirmation of EGRF positive sensitive mutation Diagnosis of brain metastases on a Gadolinium-enhanced MRI Exclusion Criteria: Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux Previous usage of radiation with brain CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Li jiancheng
    Phone
    86+13906900190
    Ext
    8613906900190
    Email
    jianchengli6@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Li jiancheng
    Phone
    8613906900190
    Ext
    8613906900190
    Email
    jianchengli6@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li jiancheng
    Organizational Affiliation
    Fujian oncology hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

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