<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/NCT02191059</url>
  </required_header>
  <id_info>
    <org_study_id>Icotinib</org_study_id>
    <nct_id>NCT02191059</nct_id>
  </id_info>
  <brief_title>Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel to Treat Lung Cancer</brief_title>
  <official_title>Single Arm, Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel as Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR:</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong Cancer Hospital and Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong Cancer Hospital and Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. There is as yet no optimal treatment regimen for patients with epidermal growth factor&#xD;
           receptor (EGFR) gene wild type non-small-cell lung cancer (NSCLC) .&#xD;
&#xD;
        2. Icotinib is a new type of small molecule EGFR TKI, developed and patented by Zhejiang&#xD;
           BetaPharma Co., Ltd.(Hangzhou, Zhejiang, China, Patent No. WO2003082830). It has the&#xD;
           similar anti-tumor activity with gefitinib, erlotinib. Pre-clinical studies showed&#xD;
           icotinib could significantly inhibit the EGFR tyrosine kinase activity. Notably,&#xD;
           anti-tumor activities were observed in patients with advanced NSCLC.&#xD;
&#xD;
        3. In this study, we will evaluate the efficiency of intermittent high dose of Icotinib in&#xD;
           combination with Docetaxel as second-line treatment for NSCLC patients with wild type&#xD;
           EGFR. The overall response rate(ORR),progression free survival(PFS) ,overall&#xD;
           survival(OS) and health related quality of life(HRQoL) will be monitored.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate(ORR)</measure>
    <time_frame>10-12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival(PFS)</measure>
    <time_frame>10-12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival(OS)</measure>
    <time_frame>10-12momths</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life(HRQoL)</measure>
    <time_frame>10-12months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Intermittent High Dose of Icotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intermittent High Dose of Icotinib in Combination With Docetaxel:&#xD;
Icotinib 625mg tablet b ymouth three times per day for day1-2, Docetaxel 75mg/m2 injection intravenous drip for day 3, 3 weeks as 1 cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Icotinib</intervention_name>
    <arm_group_label>Intermittent High Dose of Icotinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <arm_group_label>Intermittent High Dose of Icotinib</arm_group_label>
    <other_name>Taxotere, Docecad</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed stage IIIB/IV NSCLC patients progressing&#xD;
             after first-line chemotherapy;&#xD;
&#xD;
          -  Patients must have stopped prior platinum-based therapy at least four weeks prior to&#xD;
             enroll and fully recovered from chemotherapy-induced toxicity;&#xD;
&#xD;
          -  Age: 18-70 years old;&#xD;
&#xD;
          -  Patients with wild-type EGFR;&#xD;
&#xD;
          -  With a histologically or cytologically confirmed measurable disease (longest diameters&#xD;
             &gt;=10mm with Spiral computed tomography (CT)and &gt;=20mm with conventional CT) according&#xD;
             to Response Evaluation Criteria in Solid Tumors (RECIST Criteria);&#xD;
&#xD;
          -  Patients must have Eastern Cooperative Oncology Group(ECOG)Performance Status of 0-2;&#xD;
&#xD;
          -  Must have an expected survival time of at least 12 weeks;&#xD;
&#xD;
          -  Patients should have adequate bone marrow function defined as an absolute peripheral&#xD;
             neutrophil count (ANC) of ≥1.5 ´ 109/L, platelet count of ≥ 75´ 109/L; Hemoglobin(Hb)&#xD;
             ≥ 9g/dL;&#xD;
&#xD;
          -  adequate hepatic function: bilirubin ≤2x the upper limit of normal,&#xD;
             glutamic-oxaloacetic transaminase(AST )and glutamate pyruvate transaminase(ALT)≤2x the&#xD;
             upper limit of normal (≤5x the upper limit of normal if evidence of liver metastases);&#xD;
&#xD;
          -  adequate renal function: bilirubin serum creatinine ≤1.5 x the upper limit of normal;&#xD;
&#xD;
          -  No malabsorption or other gastrointestinal disorders affecting drug absorption;&#xD;
&#xD;
          -  Female patients of childbearing potential must have a negative serum or urine&#xD;
             pregnancy test within 7 days prior to study entry.Male patients must use at least one&#xD;
             reliable form of contraception during treatment and within 3 months after treatment;&#xD;
&#xD;
          -  Patients have provided a signed Informed Consent Form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Experience of Anti-EGFR Monoclonal Antibody or small molecular compounds therapy such&#xD;
             as gefitinib, cetuximab, erlotinib or trastuzumab;&#xD;
&#xD;
          -  Concomitant use with phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's&#xD;
             Wort;&#xD;
&#xD;
          -  Allergic to icotinib or any of the excipients of this product.&#xD;
&#xD;
          -  Prior chemotherapy with any paclitaxel agents;&#xD;
&#xD;
          -  Central nervous system (CNS) metastases without radiotherapy and/or surgery;&#xD;
&#xD;
          -  Evidence of clinically active Interstitial lung diseases;&#xD;
&#xD;
          -  Severe systemic disease out of control such as unstable or uncompensated&#xD;
             respiratory,cardiac,liver,renal diseases;&#xD;
&#xD;
          -  Patient has a concurrent malignancy or has a malignancy within 5 years of study&#xD;
             enrollment, (with the exception of non melanoma skin cancer or cervical carcinoma in&#xD;
             situ);&#xD;
&#xD;
          -  Psychiatric illness that would prevent the patient from giving informed consent;&#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;
&#xD;
          -  Patient is concurrently using other approved or investigational antineoplastic agent;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  Positive epidermal growth factor receptor mutation.&#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>Zhehai Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shandong Cancer Hospital and Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhehai Wang, MD</last_name>
    <phone>0086-531-67626331</phone>
    <email>wzhai8778@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shandong Cancer Hospital and Institute</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250117</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Zhehai Wang, MD</last_name>
      <phone>0086-531-67626331</phone>
      <email>wzhai8778@sina.com</email>
    </contact>
    <investigator>
      <last_name>Zhehai Wang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 30, 2014</last_update_submitted>
  <last_update_submitted_qc>July 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong Cancer Hospital and Institute</investigator_affiliation>
    <investigator_full_name>Zhehai Wang</investigator_full_name>
    <investigator_title>Vice President</investigator_title>
  </responsible_party>
  <keyword>Non Small Cell Lung Cancer</keyword>
  <keyword>Wild Type EGFR</keyword>
  <keyword>Icotinib</keyword>
  <keyword>Second-line Treatment</keyword>
  <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>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/NCT02191059
org study id: Icotinib
nct id: NCT02191059
lead sponsor: 
has dmc: Yes
1. There is as yet no optimal treatment regimen for patients with epidermal growth factor
           receptor (EGFR) gene wild type non-small-cell lung cancer (NSCLC) .

        2. Icotinib is a new type of small molecule EGFR TKI, developed and patented by Zhejiang
           BetaPharma Co., Ltd.(Hangzhou, Zhejiang, China, Patent No. WO2003082830). It has the
           similar anti-tumor activity with gefitinib, erlotinib. Pre-clinical studies showed
           icotinib could significantly inhibit the EGFR tyrosine kinase activity. Notably,
           anti-tumor activities were observed in patients with advanced NSCLC.

        3. In this study, we will evaluate the efficiency of intermittent high dose of Icotinib in
           combination with Docetaxel as second-line treatment for NSCLC patients with wild type
           EGFR. The overall response rate(ORR),progression free survival(PFS) ,overall
           survival(OS) and health related quality of life(HRQoL) will be monitored.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate(ORR)
time frame: 10-12 months
measure: Progression Free Survival(PFS)
time frame: 10-12 months
measure: Overall Survival(OS)
time frame: 10-12momths
measure: Health Related Quality of Life(HRQoL)
time frame: 10-12months
arm group label: Intermittent High Dose of Icotinib
arm group type: Experimental
description: Intermittent High Dose of Icotinib in Combination With Docetaxel:
Icotinib 625mg tablet b ymouth three times per day for day1-2, Docetaxel 75mg/m2 injection intravenous drip for day 3, 3 weeks as 1 cycle
intervention type: Drug
intervention name: Icotinib
arm group label: Intermittent High Dose of Icotinib
intervention type: Drug
intervention name: Docetaxel
arm group label: Intermittent High Dose of Icotinib
other name: Taxotere, Docecad
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Zhehai Wang, MD
role: Principal Investigator
affiliation: Shandong Cancer Hospital and Institute
last name: Zhehai Wang, MD
phone: 0086-531-67626331
email: wzhai8778@sina.com
facility: 
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong Cancer Hospital and Institute
investigator full name: Zhehai Wang
investigator title: Vice President
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Docetaxel