<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/NCT02194556</url>
  </required_header>
  <id_info>
    <org_study_id>BD-IC-IV69</org_study_id>
    <nct_id>NCT02194556</nct_id>
  </id_info>
  <brief_title>Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC</brief_title>
  <official_title>Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Untreated Advanced Non-small-cell Lung Cancer: a Randomized, Open-label Study</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 randomised, controlled, open-label, prospective trial is designed to assess the efficacy&#xD;
      and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus&#xD;
      Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer&#xD;
      patients with EGFR mutation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 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>15 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>24 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>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>24 months</time_frame>
    <description>Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>24 months</time_frame>
    <description>The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>24 months</time_frame>
    <description>Disease control rate including complete response (CR) o，partial response (PR) , stable disease (SD)</description>
  </secondary_outcome>
  <number_of_arms>2</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>Sequential and maintenance icotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance icotinib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib (125 mg three times per day) as maintenance treatment until disease progression or intolerable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sequential and maintenance icotinib</intervention_name>
    <description>Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, sequential icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib until disease progression or intolerable toxicity.</description>
    <arm_group_label>Sequential and maintenance icotinib</arm_group_label>
    <other_name>Gemzar</other_name>
    <other_name>DDP</other_name>
    <other_name>Comana, BPI-2009</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maintenance icotinib</intervention_name>
    <description>Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib (125 mg three times per day) until disease progression or intolerable toxicity.</description>
    <arm_group_label>Maintenance icotinib</arm_group_label>
    <other_name>Gemzar</other_name>
    <other_name>DDP</other_name>
    <other_name>Comana, BPI-2009</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage IV or IIIB advanced non-small cell lung cancer patients&#xD;
&#xD;
          -  Positive EGFR Mutation&#xD;
&#xD;
          -  Non-progressive disease after first-line gemcitabine/cisplatin therapy&#xD;
&#xD;
          -  Measurable lesion according to RECIST 1.1 with at least one measurable lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small&#xD;
             molecular agent such as gefitinib, erlotinib and so on&#xD;
&#xD;
          -  Patients with wild-type EGFR&#xD;
&#xD;
          -  Evidence of interstitial lung diseases&#xD;
&#xD;
          -  Severe hypersensitivity to icotinib or any of the excipients of this product.&#xD;
&#xD;
          -  Evidence of any other significant clinical disorder or laboratory finding that makes&#xD;
             it undesirable for the subject to participate in the study&#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>Xiaohua Hu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Guangxi Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>First Affiliated Hospital of Guangxi Medical University</name>
      <address>
        <city>NanNing</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</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>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>Gemcitabine</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/NCT02194556
org study id: BD-IC-IV69
nct id: NCT02194556
lead sponsor: 
has dmc: Yes
This randomised, controlled, open-label, prospective trial is designed to assess the efficacy
      and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus
      Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer
      patients with EGFR mutation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: 15 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: 24 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.
measure: Objective response rate
time frame: 24 months
description: Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
measure: Adverse events
time frame: 24 months
description: The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
measure: Disease control rate (DCR)
time frame: 24 months
description: Disease control rate including complete response (CR) o，partial response (PR) , stable disease (SD)
arm group label: Sequential and maintenance icotinib
arm group type: Experimental
description: Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
arm group label: Maintenance icotinib
arm group type: Active Comparator
description: Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib (125 mg three times per day) as maintenance treatment until disease progression or intolerable toxicity.
intervention type: Drug
intervention name: Sequential and maintenance icotinib
description: Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, sequential icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib until disease progression or intolerable toxicity.
arm group label: Sequential and maintenance icotinib
other name: Gemzar
other name: DDP
other name: Comana, BPI-2009
intervention type: Drug
intervention name: Maintenance icotinib
description: Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib (125 mg three times per day) until disease progression or intolerable toxicity.
arm group label: Maintenance icotinib
other name: Gemzar
other name: DDP
other name: Comana, BPI-2009
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xiaohua Hu, MD
role: Principal Investigator
affiliation: First Affiliated Hospital of Guangxi Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Gemcitabine