<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/NCT03008109</url>
  </required_header>
  <id_info>
    <org_study_id>AirFGH</org_study_id>
    <nct_id>NCT03008109</nct_id>
  </id_info>
  <brief_title>Endostar Plus EGFR-TKI（Epidermal Growth Factor Receptor-Tyrosine-Kinase Inhibitor） as a Treatment of EGFR Mutation-positive NSCLC</brief_title>
  <official_title>Short-term Injection of Recombinant Human Endostatin Plus EGFR-TKI as a Treatment of EGFR Mutation-positive Advanced Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zaiwen Fan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force General Hospital of the PLA</source>
  <brief_summary>
    <textblock>
      EGFR Tyrosine-Kinase Inhibitor monotherapy is widely used in treatment of patients with EGFR&#xD;
      mutation-positive Non-small cell lung cancer(NSCLC), In despite of the benefit of PFS&#xD;
      （progression-free survival） , the OS （ overall survival） is limited extended. This study is&#xD;
      aim to observe the safety and efficacy of the combination of an anti-angiogenic drug&#xD;
      recombinant human-endostatin with EGFR TKI ,to find out a new strategy which may further&#xD;
      extend the PFS and OS with a tolerated toxicity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>18 month</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Advanced Cancer</condition>
  <condition>Lung Cancer, Nonsmall Cell</condition>
  <arm_group>
    <arm_group_label>EGFR-TK inhibitor plus RH-endostatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EGFR-TKI icotinib:125mg Tid RH-endostatin:15mg/m2 ,d1-7</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EGFR-TK Inhibitor</intervention_name>
    <arm_group_label>EGFR-TK inhibitor plus RH-endostatin</arm_group_label>
    <other_name>Recombinant human endostatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced NSCLC,EGFR mutation positive,PS（performance status） 0-2,Patients were&#xD;
             required to have one or more measurable lesions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zaiwen Fan, MD</last_name>
    <phone>+86 18610949919</phone>
    <email>kzzaiwenfan@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhaoyuan Shi, Bachelor</last_name>
    <phone>+86 15801570739</phone>
    <email>szy957@aliyun.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Gridelli C, Rossi A, Ciardiello F, De Marinis F, Crino L, Morabito A, Morgillo F, Montanino A, Daniele G, Piccirillo MC, Normanno N, Gallo C, Perrone F. BEVERLY: Rationale and Design of a Randomized Open-Label Phase III Trial Comparing Bevacizumab Plus Erlotinib Versus Erlotinib Alone as First-Line Treatment of Patients With EGFR-Mutated Advanced Nonsquamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2016 Sep;17(5):461-465. doi: 10.1016/j.cllc.2016.04.001. Epub 2016 Apr 22.</citation>
    <PMID>27209164</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Air Force General Hospital of the PLA</investigator_affiliation>
    <investigator_full_name>Zaiwen Fan</investigator_full_name>
    <investigator_title>Director of oncology department</investigator_title>
  </responsible_party>
  <keyword>EGFR-TKI</keyword>
  <keyword>Recombinant human endostatin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endostatins</mesh_term>
  </intervention_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/NCT03008109
org study id: AirFGH
nct id: NCT03008109
lead sponsor: 
EGFR Tyrosine-Kinase Inhibitor monotherapy is widely used in treatment of patients with EGFR
      mutation-positive Non-small cell lung cancer(NSCLC), In despite of the benefit of PFS
      （progression-free survival） , the OS （ overall survival） is limited extended. This study is
      aim to observe the safety and efficacy of the combination of an anti-angiogenic drug
      recombinant human-endostatin with EGFR TKI ,to find out a new strategy which may further
      extend the PFS and OS with a tolerated toxicity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression-free survival
time frame: 18 month
arm group label: EGFR-TK inhibitor plus RH-endostatin
arm group type: Experimental
description: EGFR-TKI icotinib:125mg Tid RH-endostatin:15mg/m2 ,d1-7
intervention type: Drug
intervention name: EGFR-TK Inhibitor
arm group label: EGFR-TK inhibitor plus RH-endostatin
other name: Recombinant human endostatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zaiwen Fan, MD
phone: +86 18610949919
email: kzzaiwenfan@163.com
last name: Zhaoyuan Shi, Bachelor
phone: +86 15801570739
email: szy957@aliyun.com
citation: Gridelli C, Rossi A, Ciardiello F, De Marinis F, Crino L, Morabito A, Morgillo F, Montanino A, Daniele G, Piccirillo MC, Normanno N, Gallo C, Perrone F. BEVERLY: Rationale and Design of a Randomized Open-Label Phase III Trial Comparing Bevacizumab Plus Erlotinib Versus Erlotinib Alone as First-Line Treatment of Patients With EGFR-Mutated Advanced Nonsquamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2016 Sep;17(5):461-465. doi: 10.1016/j.cllc.2016.04.001. Epub 2016 Apr 22.
PMID: 27209164
responsible party type: Sponsor-Investigator
investigator affiliation: Air Force General Hospital of the PLA
investigator full name: Zaiwen Fan
investigator title: Director of oncology department
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Endostatins