<clinical_study>
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  <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/NCT02215356</url>
  </required_header>
  <id_info>
    <org_study_id>BD-IC-IV66</org_study_id>
    <nct_id>NCT02215356</nct_id>
  </id_info>
  <brief_title>Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer</brief_title>
  <official_title>Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomised, multi-center, controlled trial is designed to assess the efficacy and safety&#xD;
      of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in&#xD;
      non-small cell lung cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomised, multi-center, controlled trial is designed to assess the efficacy and safety&#xD;
      of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent&#xD;
      radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary&#xD;
      endpoint is progression-free survival&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2018</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>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>54 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Chemoradiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Etoposide 50mg/m2, ivgtt, d1-d5, cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles, while chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times). Progressive patients will be administered oral icotinib 125 mg three times daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Icotinib with concurrent radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times), while icotinib 125mg three times daily (375 mg per day) by mouth. Maintenance icotinib will be administered after radiotherapy. Progressive patients will receive chemotherapy, using the platinum-based two-drug chemotherapy regimen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Icotinib with concurrent radiotherapy</intervention_name>
    <description>Icotinib: 125 mg is administered orally three times per day.</description>
    <arm_group_label>Icotinib with concurrent radiotherapy</arm_group_label>
    <other_name>Icotinib</other_name>
    <other_name>Comana</other_name>
    <other_name>BPI-2009</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemoradiotherapy</intervention_name>
    <description>Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles</description>
    <arm_group_label>Chemoradiotherapy</arm_group_label>
    <other_name>VP16</other_name>
    <other_name>DDP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation&#xD;
&#xD;
          -  No previous systemic anticancer therapy&#xD;
&#xD;
          -  Measurable lesion according to RECIST with at least one measurable lesion not&#xD;
             previously irradiated, unless disease progression has been documented at that site&#xD;
&#xD;
          -  ECOG Performance Status of 0 to 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal&#xD;
             antibody or small molecular compounds therapy such as gefitinib, erlotinib or&#xD;
             cetuximab&#xD;
&#xD;
          -  Evidence of clinically active Interstitial Lung Diseases (patients with chronic,&#xD;
             stable, radiographic changes who are asymptomatic need not be excluded)&#xD;
&#xD;
          -  Known severe hypersensitivity to icotinib or any of the excipients of this product&#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>Lvhua Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaolong Fu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Chest Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciences Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Liberation Army 307 Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100039</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongguan City People's Hospital</name>
      <address>
        <city>Dongguan</city>
        <state>Guangdong</state>
        <zip>523059</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen Cancer Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangxi Zhuang Autonomous Region People's Hospital</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Provincial Tumor Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Cancer Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nantong Tumor Hospital</name>
      <address>
        <city>Nantong</city>
        <state>Jiangsu</state>
        <zip>226361</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangxi Provincial Cancer Hospital</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tumor Hospital of Jilin Province</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaoning Provincial Tumor Hospital</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Cancer Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Tumor Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sichuan Provincial Tumor Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Cancer Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xinjiang Medical University</name>
      <address>
        <city>Wulumuqi</city>
        <state>Xinjiang</state>
        <zip>830000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tumor Hospital of Yunnan Province</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650118</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hangzhou First People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 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>
  <!-- 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/NCT02215356
org study id: BD-IC-IV66
nct id: NCT02215356
lead sponsor: 
has dmc: Yes
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety
      of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in
      non-small cell lung cancer
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety
      of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent
      radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary
      endpoint is progression-free survival
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: 24 months
measure: Overall survival
time frame: 36 months
measure: Objective response rate
time frame: 8 weeks
measure: Adverse events
time frame: 54 months
arm group label: Chemoradiotherapy
arm group type: Active Comparator
description: Etoposide 50mg/m2, ivgtt, d1-d5, cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles, while chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times). Progressive patients will be administered oral icotinib 125 mg three times daily.
arm group label: Icotinib with concurrent radiotherapy
arm group type: Experimental
description: Chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times), while icotinib 125mg three times daily (375 mg per day) by mouth. Maintenance icotinib will be administered after radiotherapy. Progressive patients will receive chemotherapy, using the platinum-based two-drug chemotherapy regimen.
intervention type: Drug
intervention name: Icotinib with concurrent radiotherapy
description: Icotinib: 125 mg is administered orally three times per day.
arm group label: Icotinib with concurrent radiotherapy
other name: Icotinib
other name: Comana
other name: BPI-2009
intervention type: Drug
intervention name: Chemoradiotherapy
description: Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
arm group label: Chemoradiotherapy
other name: VP16
other name: DDP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Lvhua Wang, MD
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Xiaolong Fu, MD
role: Principal Investigator
affiliation: Shanghai Chest Hospital
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country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung