<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/NCT01707329</url>
  </required_header>
  <id_info>
    <org_study_id>BD-IC-IV44</org_study_id>
    <nct_id>NCT01707329</nct_id>
  </id_info>
  <brief_title>Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Progressed After Icotinib Treatment</brief_title>
  <official_title>A Phase II Randomised, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Who Have Progressed After Icotinib Treatment in NSCLC</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 phase II randomised, double blind, placebo controlled, multicentre trial is designed to&#xD;
      assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy&#xD;
      alone in patients who have progressed after benefiting from previous second or third-line&#xD;
      icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2016</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</measure>
    <time_frame>6 months</time_frame>
    <description>A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant&#xD;
are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>12 months</time_frame>
    <description>Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Icotinib+Chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.</description>
    <arm_group_label>Chemotherapy</arm_group_label>
    <other_name>Taxotere</other_name>
    <other_name>ALIMTA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Icotinib+chemotherapy</intervention_name>
    <description>Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.</description>
    <arm_group_label>Icotinib+Chemotherapy</arm_group_label>
    <other_name>Icotinib</other_name>
    <other_name>Comana</other_name>
    <other_name>BPI-2009</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients&#xD;
             confirmed by sputum cytology)&#xD;
&#xD;
          -  No previous targeted treatment such as gefitinib, erlotinib.&#xD;
&#xD;
          -  With a measurable disease(longest diameters &gt;=10mm with Spiral computed tomography&#xD;
             (CT)and &gt;=20mm with conventional CT) according to RECIST Criteria&#xD;
&#xD;
          -  WHO performance status(PS)&lt;= 2&#xD;
&#xD;
          -  N&gt;=1.5×109/L, Plt&gt;=1.0×109/L,Hb&gt;=10g/dL;AST&amp;ALT should &lt;3ULN(without liver metastasis)&#xD;
             or &lt;5ULN(with liver metastasis).TBIL&lt;=1.5ULN.&#xD;
&#xD;
          -  Signed and dated informed consent before the start of specific protocol procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to icotinib&#xD;
&#xD;
          -  Patients with metastatic brain tumors with symptoms.&#xD;
&#xD;
          -  Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or&#xD;
             small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.&#xD;
&#xD;
          -  Severe systemic disease out of control such as unstable or uncompensated&#xD;
             respiratory,cardiac,liver,renal diseases.&#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>Zhang Yi Ping, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhang Yi Ping, MD</last_name>
    <phone>0086-13750881678</phone>
    <email>zyp@medmail.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hunan Province Tumor Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410205</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Medical School of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhang Yi Ping, M.D.</last_name>
      <phone>0086-13750881678</phone>
      <email>zyp@medmail.com.cn</email>
    </contact>
    <investigator>
      <last_name>Zhang Yi Ping, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Wenzhou Medical College</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>September 5, 2015</last_update_submitted>
  <last_update_submitted_qc>September 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT01707329
org study id: BD-IC-IV44
nct id: NCT01707329
lead sponsor: 
has dmc: Yes
This phase II randomised, double blind, placebo controlled, multicentre trial is designed to
      assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy
      alone in patients who have progressed after benefiting from previous second or third-line
      icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung
      cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: 6 months
description: A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant
are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
measure: Overall survival
time frame: 12 months
description: Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
arm group label: Chemotherapy
arm group type: Active Comparator
description: Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
arm group label: Icotinib+Chemotherapy
arm group type: Experimental
description: Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
intervention type: Drug
intervention name: Chemotherapy
description: Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
arm group label: Chemotherapy
other name: Taxotere
other name: ALIMTA
intervention type: Drug
intervention name: Icotinib+chemotherapy
description: Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
arm group label: Icotinib+Chemotherapy
other name: Icotinib
other name: Comana
other name: BPI-2009
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhang Yi Ping, M.D.
role: Principal Investigator
affiliation: Zhejiang Cancer Hospital
last name: Zhang Yi Ping, MD
phone: 0086-13750881678
email: zyp@medmail.com.cn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung