<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03754530</url>
  </required_header>
  <id_info>
    <org_study_id>2018-007-02</org_study_id>
    <nct_id>NCT03754530</nct_id>
  </id_info>
  <brief_title>Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Betta Pharmaceuticals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Betta Pharmaceuticals Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of icotinib in combination with&#xD;
      radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of&#xD;
      intracranial lesions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence&#xD;
      of brain metastases. Patients with brain metastasis showed poor prognosis and displayed an&#xD;
      untreated median survival of only 3-6 months, and most patients died due to the progression&#xD;
      of brain metastases. Some research showed that Icotinib alone can improve the efficiency of&#xD;
      NSCLC with brain metastases, but there is still unknow about the result about combination&#xD;
      with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib&#xD;
      combined with radiotherapy for NSCLC patients with brain metastases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival of intracranial lesions</measure>
    <time_frame>10 months</time_frame>
    <description>Number of participants with progress of intracranial lesions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>8 months</time_frame>
    <description>Number of participants with progress of any places in body</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate of intracranial lesions</measure>
    <time_frame>8 weeks</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">162</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <condition>Brain Metastases</condition>
  <arm_group>
    <arm_group_label>Icotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>icotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(&gt;3 with WBRT or &lt;=3 with SRS) after PD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Icotinib plus radiation therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(&gt;3), or SRS(&lt;=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Icotinib</intervention_name>
    <description>orally three times per day</description>
    <arm_group_label>Icotinib</arm_group_label>
    <arm_group_label>Icotinib plus radiation therapy</arm_group_label>
    <other_name>WBRT or SRS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>WBRT or SRS</intervention_name>
    <description>&gt;3 with WBRT;&lt;=3 with SRS</description>
    <arm_group_label>Icotinib plus radiation therapy</arm_group_label>
    <other_name>Icotinib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological confirmation of non-small-cell lung cancer (NSCLC) with&#xD;
             brain metastases&#xD;
&#xD;
          -  Histological or cytological confirmation of EGRF positive sensitive mutation&#xD;
&#xD;
          -  Diagnosis of brain metastases on a Gadolinium-enhanced MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin,&#xD;
             erbitux&#xD;
&#xD;
          -  Previous usage of radiation with brain&#xD;
&#xD;
          -  CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li jiancheng</last_name>
    <role>Study Director</role>
    <affiliation>Fujian oncology hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li jiancheng</last_name>
    <phone>86+13906900190</phone>
    <phone_ext>8613906900190</phone_ext>
    <email>jianchengli6@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Li jiancheng</last_name>
    <phone>8613906900190</phone>
    <phone_ext>8613906900190</phone_ext>
    <email>jianchengli6@126.com</email>
  </overall_contact_backup>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 31, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NSCLC brain metastases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03754530
org study id: 2018-007-02
nct id: NCT03754530
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival of intracranial lesions
time frame: 10 months
description: Number of participants with progress of intracranial lesions
measure: Progression-free survival
time frame: 8 months
description: Number of participants with progress of any places in body
measure: Objective response rate of intracranial lesions
time frame: 8 weeks
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
arm group label: Icotinib
arm group type: Experimental
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 group label: Icotinib plus radiation therapy
arm group type: Experimental
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: Icotinib
description: orally three times per day
arm group label: Icotinib
arm group label: Icotinib plus radiation therapy
other name: WBRT or SRS
intervention type: Radiation
intervention name: WBRT or SRS
description: >3 with WBRT;<=3 with SRS
arm group label: Icotinib plus radiation therapy
other name: Icotinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Li jiancheng
role: Study Director
affiliation: Fujian oncology hospital
last name: Li jiancheng
phone: 86+13906900190
phone ext: 8613906900190
email: jianchengli6@126.com
last name: Li jiancheng
phone: 8613906900190
phone ext: 8613906900190
email: jianchengli6@126.com
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Brain Neoplasms