<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/NCT01690390</url>
  </required_header>
  <id_info>
    <org_study_id>BD-IV-43</org_study_id>
    <nct_id>NCT01690390</nct_id>
  </id_info>
  <brief_title>Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease</brief_title>
  <official_title>An Open-label, Randomized, Multicenter, Phase II Trial to Evaluate the Safety and Efficacy of Dose Escalation of Icotinib in Advanced or Metastatic NSCLC Patients After 8 Weeks Routine Therapy Evaluated as Stable Disease</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>
      The primary purposes of this study are to assess the safety and efficacy of using high doses&#xD;
      of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer&#xD;
      that achieve stable disease after 8 weeks routine therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center phase II randomized controlled study to assess the safety and efficacy&#xD;
      of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small&#xD;
      cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS, as well as&#xD;
      OS and DCR. The adverse events and adverse reaction are evaluated as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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 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>15 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>Transformation rate from stable disease to complete response or partial response</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of participants with an stable disease previously achieve complete response or partial response after dose escalation. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence rate of adverse events</measure>
    <time_frame>40 months</time_frame>
    <description>Number of patients with a adverse event, identified according to the Common Toxicity Criteria (CTC) in evaluable-for-safety population, which included all patients who received at least 1 dose of study medication.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>NSCLC</condition>
  <arm_group>
    <arm_group_label>Icotinib of Routine Dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral Drug icotinib 125 mg three times per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Icotinib of High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Drug icotinib 250 mg three times per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Icotinib of routine dose</intervention_name>
    <description>Icotinib of routine dose: 125 mg is administered orally three times per day.</description>
    <arm_group_label>Icotinib of Routine Dose</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>Icotinib of high dose</intervention_name>
    <description>Icotinib: 250 mg is administered orally three times per day.</description>
    <arm_group_label>Icotinib of High Dose</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) at least 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, M.D.</last_name>
    <phone>0086-13750881678</phone>
    <email>zyp@medmail.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fujian Hospital for Chest Tumors &amp; Tuberculosis Diseases</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chen Qun, M.D.</last_name>
      <phone>0086-13860669883</phone>
    </contact>
    <investigator>
      <last_name>Chen Qun, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fujian Provincal Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cui Tongjian, M.D.</last_name>
      <phone>0086-13905920326</phone>
    </contact>
    <investigator>
      <last_name>Cui Tongjian, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fujian Provincal Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huang Cheng, M.D.</last_name>
      <phone>0086-13905010397</phone>
    </contact>
    <investigator>
      <last_name>Huang Cheng, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The second hospital of Xiamen City</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361024</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ke Mingyao, M.D.</last_name>
      <phone>0086-13860166866</phone>
    </contact>
    <investigator>
      <last_name>Ke Mingyao, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hunan Provincal Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wu Lin, M.D.</last_name>
      <phone>0086-13706671349</phone>
    </contact>
    <investigator>
      <last_name>Wu Lin, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second People's Hospital of Sichuan</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yu Jingrui, M.D.</last_name>
      <phone>0086-13551237583</phone>
    </contact>
    <investigator>
      <last_name>Yu Jingrui, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Recruiting</status>
    <contact>
      <last_name>Pan Minghong, M.D.</last_name>
      <phone>0086-57186006</phone>
      <phone_ext>922</phone_ext>
      <email>panhongming@tom.com</email>
    </contact>
    <investigator>
      <last_name>Pan Minghong, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Recruiting</status>
    <contact>
      <last_name>Zhou Jianying, M.D.</last_name>
      <phone>0086-13750881678</phone>
      <email>drzjy@163.com</email>
    </contact>
    <investigator>
      <last_name>Zhou Jianying, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Recruiting</status>
    <contact>
      <last_name>Huang Jianjin, M.D.</last_name>
      <phone>0086-13989889688</phone>
      <email>hhjj@medmail.com.cn</email>
    </contact>
    <investigator>
      <last_name>Huang Jianjin, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Zhejiang Traditional Chinese Medical Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zhejiang Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310007</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zhejiang Provincial People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lu Li Qin, M.D.</last_name>
      <phone>0086-13858039628</phone>
      <email>llq99999@yahoo.com.cn</email>
    </contact>
    <investigator>
      <last_name>Lu Li Qin, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yinzhou People's Hospital</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guo Jianxin, M.D.</last_name>
      <phone>0086-13605741696</phone>
    </contact>
    <investigator>
      <last_name>Guo Jianxin, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ningbo Medical Treatment Center Lihuili Hospital</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315046</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shen Weiyu, M.D.</last_name>
      <phone>0086-13805876129</phone>
    </contact>
    <investigator>
      <last_name>Shen Weiyu, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Taizhou Hospital of Zhejiang Province</name>
      <address>
        <city>Taizhou</city>
        <state>Zhejiang</state>
        <zip>317000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hu Wei, M.D.</last_name>
      <phone>0086-13606657129</phone>
    </contact>
    <investigator>
      <last_name>Hu Wei, 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>Recruiting</status>
    <contact>
      <last_name>Li Wenfeng, M.D.</last_name>
      <phone>0086-13968840592</phone>
    </contact>
    <investigator>
      <last_name>Li Wenfeng, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>December 26, 2014</last_update_submitted>
  <last_update_submitted_qc>December 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 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>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/NCT01690390
org study id: BD-IV-43
nct id: NCT01690390
lead sponsor: 
has dmc: Yes
The primary purposes of this study are to assess the safety and efficacy of using high doses
      of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer
      that achieve stable disease after 8 weeks routine therapy.
This is a multi-center phase II randomized controlled study to assess the safety and efficacy
      of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small
      cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS, as well as
      OS and DCR. The adverse events and adverse reaction are evaluated as well.
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: 15 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: Transformation rate from stable disease to complete response or partial response
time frame: 6 weeks
description: Number of participants with an stable disease previously achieve complete response or partial response after dose escalation. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.
measure: Incidence rate of adverse events
time frame: 40 months
description: Number of patients with a adverse event, identified according to the Common Toxicity Criteria (CTC) in evaluable-for-safety population, which included all patients who received at least 1 dose of study medication.
arm group label: Icotinib of Routine Dose
arm group type: Active Comparator
description: Oral Drug icotinib 125 mg three times per day
arm group label: Icotinib of High Dose
arm group type: Experimental
description: Oral Drug icotinib 250 mg three times per day
intervention type: Drug
intervention name: Icotinib of routine dose
description: Icotinib of routine dose: 125 mg is administered orally three times per day.
arm group label: Icotinib of Routine Dose
other name: Icotinib
other name: Comana
other name: BPI-2009
intervention type: Drug
intervention name: Icotinib of high dose
description: Icotinib: 250 mg is administered orally three times per day.
arm group label: Icotinib of High Dose
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, M.D.
phone: 0086-13750881678
email: zyp@medmail.com.cn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung