<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/NCT01665417</url>
  </required_header>
  <id_info>
    <org_study_id>BD-IC-IV08</org_study_id>
    <nct_id>NCT01665417</nct_id>
  </id_info>
  <brief_title>Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma</brief_title>
  <official_title>Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to compare the efficacy and safety of first-line icotinib treatment&#xD;
      and first-line chemotherapy followed by maintenance treatment with icotinib.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to compare the efficacy and safety of first-line icotinib treatment&#xD;
      and first-line chemotherapy followed by maintenance with icotinib.&#xD;
&#xD;
      Primary endpoint:&#xD;
&#xD;
      Progression-free survival between first-line icotinib treatment and first-line chemotherapy&#xD;
      followed by maintenance with icotinib&#xD;
&#xD;
      Secondary endpoint:&#xD;
&#xD;
        1. Overall survival between icotinib and chemotherapy&#xD;
&#xD;
        2. Time to Progression between icotinib and chemotherapy&#xD;
&#xD;
        3. Objective response rate and disease control rate between icotinib and chemotherapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>Phase 4</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</measure>
    <time_frame>8 months</time_frame>
    <description>PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>24 months</time_frame>
    <description>OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Tumor Progression</measure>
    <time_frame>8 months</time_frame>
    <description>TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>3 months</time_frame>
    <description>Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>24 months</time_frame>
    <description>Adverse events assessed by CTCAE4.0.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>EGFR Positive Non-small Cell Lung Cancer</condition>
  <condition>Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Experimental Icotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Icotinib: 125mg, oral administration, three times per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy Regimen 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy Regimen 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Experimental</intervention_name>
    <description>Icotinib: 125mg, oral administration, three times per day.</description>
    <arm_group_label>Experimental Icotinib</arm_group_label>
    <other_name>BPI-2009</other_name>
    <other_name>Commana</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.</description>
    <arm_group_label>Chemotherapy Regimen 1</arm_group_label>
    <arm_group_label>Chemotherapy Regimen 2</arm_group_label>
    <other_name>Pemetrexe</other_name>
    <other_name>ALIMTA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.</description>
    <arm_group_label>Chemotherapy Regimen 1</arm_group_label>
    <arm_group_label>Chemotherapy Regimen 2</arm_group_label>
    <other_name>Docetaxel</other_name>
    <other_name>Taxotere</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at&#xD;
             least one lesion that can be accurately measured in at least one dimension (longest&#xD;
             diameter to be recorded on CT); Patients must have previously untreated locally&#xD;
             advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR&#xD;
             activating mutation (exon 19 deletion, L858R).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that&#xD;
             target EGFR Patients must not be receiving any other investigational agents Any&#xD;
             evidence of interstitial lung disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiao Shunchang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese People's Liberation Army (PLA) General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fang Jian, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bai Chunmei, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liu Wei, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hebei Provincal Tumor Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiao Shunchang, MD</last_name>
    <phone>0086-13801380677</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese People's Liberation Army (PLA) General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiao Shunchang, MD</last_name>
      <phone>0086-13801380677</phone>
    </contact>
    <investigator>
      <last_name>Jiao Shunchang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>February 7, 2017</last_update_submitted>
  <last_update_submitted_qc>February 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Icotinib</keyword>
  <keyword>EGFR positive mutation</keyword>
  <keyword>First-line treatment</keyword>
  <keyword>Maintenance treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</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/NCT01665417
org study id: BD-IC-IV08
nct id: NCT01665417
lead sponsor: 
has dmc: Yes
This study is designed to compare the efficacy and safety of first-line icotinib treatment
      and first-line chemotherapy followed by maintenance treatment with icotinib.
This study is designed to compare the efficacy and safety of first-line icotinib treatment
      and first-line chemotherapy followed by maintenance with icotinib.

      Primary endpoint:

      Progression-free survival between first-line icotinib treatment and first-line chemotherapy
      followed by maintenance with icotinib

      Secondary endpoint:

        1. Overall survival between icotinib and chemotherapy

        2. Time to Progression between icotinib and chemotherapy

        3. Objective response rate and disease control rate between icotinib and chemotherapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: 8 months
description: PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
measure: Overall survival
time frame: 24 months
description: OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.
measure: Time to Tumor Progression
time frame: 8 months
description: TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
measure: Objective response rate
time frame: 3 months
description: Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1.
measure: Number of participants with adverse events
time frame: 24 months
description: Adverse events assessed by CTCAE4.0.
arm group label: Experimental Icotinib
arm group type: Experimental
description: Icotinib: 125mg, oral administration, three times per day.
arm group label: Chemotherapy Regimen 1
arm group type: Active Comparator
description: Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
arm group label: Chemotherapy Regimen 2
arm group type: Active Comparator
description: Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
intervention type: Drug
intervention name: Experimental
description: Icotinib: 125mg, oral administration, three times per day.
arm group label: Experimental Icotinib
other name: BPI-2009
other name: Commana
intervention type: Drug
intervention name: Chemotherapy
description: Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
arm group label: Chemotherapy Regimen 1
arm group label: Chemotherapy Regimen 2
other name: Pemetrexe
other name: ALIMTA
intervention type: Drug
intervention name: Chemotherapy
description: Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
arm group label: Chemotherapy Regimen 1
arm group label: Chemotherapy Regimen 2
other name: Docetaxel
other name: Taxotere
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jiao Shunchang, MD
role: Principal Investigator
affiliation: Chinese People's Liberation Army (PLA) General Hospital
last name: Fang Jian, MD
role: Study Director
affiliation: Peking University Cancer Hospital & Institute
last name: Bai Chunmei, MD
role: Study Director
affiliation: Peking Union Medical College Hospital
last name: Liu Wei, MD
role: Study Director
affiliation: Hebei Provincal Tumor Hospital
last name: Jiao Shunchang, MD
phone: 0086-13801380677
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Adenocarcinoma of Lung
mesh term: Docetaxel