<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/NCT02264210</url>
  </required_header>
  <id_info>
    <org_study_id>GASTO1003</org_study_id>
    <secondary_id>wsy004</secondary_id>
    <nct_id>NCT02264210</nct_id>
  </id_info>
  <brief_title>Icotinib for Completed Resected IB NSCLC With EGFR Mutation</brief_title>
  <acronym>CORIN</acronym>
  <official_title>A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well icotinib works in treating patients with completely&#xD;
      resected stage IB NSCLC harboring EGFR mutation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages&#xD;
      IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor&#xD;
      receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR&#xD;
      mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group&#xD;
      of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had&#xD;
      non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to&#xD;
      see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR&#xD;
      mutation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Disease-free survival</measure>
    <time_frame>From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 5 years</time_frame>
    <description>DFS will be estimated by the method of Kaplan-Meier</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From randomization to the time of death as a result of any cause, assessed up to 5 years</time_frame>
    <description>OS will be estimated by the method of Kaplan-Meier</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Lung Neoplasms</condition>
  <condition>Squamous Cell Lung Cancer</condition>
  <condition>Adenocarcinoma of the Lung</condition>
  <condition>Adenosquamous Cell Lung Cancer</condition>
  <condition>Large Cell Lung Cancer</condition>
  <condition>Bronchial Neoplasms</condition>
  <condition>Stage IB Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Observation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Icotinib</intervention_name>
    <description>Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>BPI-2009</other_name>
    <other_name>Conmana</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent provided.&#xD;
&#xD;
          -  Males or females, Aged 18-75 years.&#xD;
&#xD;
          -  Able to comply with the required protocol and follow-up procedures, and able to&#xD;
             receive oral medications.&#xD;
&#xD;
          -  Had completely resected pathological confirmed stage IIA-IIIA NSCLC.&#xD;
&#xD;
          -  EGFR activating mutation in exon 19 or 21.&#xD;
&#xD;
          -  Patient who can start the investigational therapy within 3-6 weeks after the complete&#xD;
             resection.&#xD;
&#xD;
          -  ECOG performance status of 0-1.&#xD;
&#xD;
          -  Had a life expectancy of 12 weeks or more.&#xD;
&#xD;
          -  Adequate hematological function, adequate liver function and renal function.&#xD;
&#xD;
          -  Female patients, except those who are postmenopausal or surgically sterilized, must&#xD;
             have a negative pre-study serum or urine pregnancy test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g.&#xD;
             erlotinib, gefitinib, cetuximab, trastuzumab).&#xD;
&#xD;
          -  Inability to comply with protocol or study procedures.&#xD;
&#xD;
          -  Had a history another malignancy in the last 5 years with the exception of cured basal&#xD;
             cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured&#xD;
             epithelial carcinoma of the bladder.&#xD;
&#xD;
          -  Any evidence confirmed tumor recurrence before investigational therapy.&#xD;
&#xD;
          -  Known severe hypersensitivity to icotinib or any of the excipients of this product.&#xD;
&#xD;
          -  Evidence of clinically active interstitial lung disease.&#xD;
&#xD;
          -  Eye inflammation not fully controlled or conditions predisposing the subject to this.&#xD;
&#xD;
          -  Any unstable systemic disease (including active infection, uncontrolled hypertension,&#xD;
             unstable angina, congestive heart failure, myocardial infarction within the previous 6&#xD;
             months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic&#xD;
             disease).&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          -  Pregnancy or breast-feeding women.&#xD;
&#xD;
          -  Ingredients mixed with small cell lung cancer patients.&#xD;
&#xD;
          -  History of neurologic or psychiatric disorders.&#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>Si-Yu Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Province Association Study of Thoracic Oncology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Si-Yu Wang, MD</last_name>
    <phone>+86 20 87343314</phone>
    <email>wsysums@163.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Si-Yu Wang, Doctor</last_name>
      <phone>+86 20 87343439</phone>
      <email>wsysums@163.net</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Si-Yu Wang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</mesh_term>
    <mesh_term>Bronchial Neoplasms</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/NCT02264210
org study id: GASTO1003
secondary id: wsy004
nct id: NCT02264210
lead sponsor: 
has dmc: No
This phase II trial studies how well icotinib works in treating patients with completely
      resected stage IB NSCLC harboring EGFR mutation.
Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages
      IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor
      receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR
      mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group
      of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had
      non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to
      see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR
      mutation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival
time frame: From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 5 years
description: DFS will be estimated by the method of Kaplan-Meier
measure: Overall survival
time frame: From randomization to the time of death as a result of any cause, assessed up to 5 years
description: OS will be estimated by the method of Kaplan-Meier
measure: Number of Participants with Adverse Events
time frame: Up to 5 years
description: The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used
arm group label: Intervention group
arm group type: Experimental
description: Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.
arm group label: Observation group
arm group type: No Intervention
description: Observation.
intervention type: Drug
intervention name: Icotinib
description: Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.
arm group label: Intervention group
other name: BPI-2009
other name: Conmana
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Si-Yu Wang, MD
role: Principal Investigator
affiliation: Guangdong Province Association Study of Thoracic Oncology
last name: Si-Yu Wang, MD
phone: +86 20 87343314
email: wsysums@163.net
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Si-Yu Wang
investigator title: Professor
mesh term: Lung Neoplasms
mesh term: Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Adenocarcinoma of Lung
mesh term: Bronchial Neoplasms