<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/NCT03749213</url>
  </required_header>
  <id_info>
    <org_study_id>BD-IC-IV82</org_study_id>
    <nct_id>NCT03749213</nct_id>
  </id_info>
  <brief_title>Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer</brief_title>
  <official_title>Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer: a Single Arm, Phase II Clinical 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the efficacy and safety of Icotinib as&#xD;
      neoadjuvant in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially&#xD;
      radical treated by surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially&#xD;
      radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times&#xD;
      per day orally for 8 weeks as neoadjuvant therapy; then patients with clinical benefits&#xD;
      receive surgical resection of the tumor. If there is curative effect of Icotinib according to&#xD;
      the RECIST or pathological report, the patients will continue receive Icotinib for two years&#xD;
      as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity. The&#xD;
      primary objective of this study is evaluate the efficacy and safety of Icotinib neoadjuvant&#xD;
      therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2022</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>Objective Response Rate</measure>
    <time_frame>eight weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>eight weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>eight weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in cT-stage</measure>
    <time_frame>eight weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pathologic complete remission rate</measure>
    <time_frame>eight weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Tumor Progression</measure>
    <time_frame>five years after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>five years after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>five years after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>EGF-R Positive Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Icotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib as neoadjuvant therapy before surgery and adjuvant therapy or till progressive disease or unaccepted toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Icotinib</intervention_name>
    <description>Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks as neoadjuvant therapy before surgery and for 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity.</description>
    <arm_group_label>Icotinib</arm_group_label>
    <other_name>Conmana</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histology or cytology confirmed Non-small Cell Lung Cancer; EGFR mutation (EGFR 19del&#xD;
             and/or 21L858R) detected by tumor tissue biopsy of primary lesion or metastatic lesion&#xD;
             or plasma ctDNA&#xD;
&#xD;
          -  No previous anti-tumor treatment such as surgery, chemotherapy, radiotherapy or&#xD;
             biological therapy&#xD;
&#xD;
          -  Stage IIIA N2 NSCLC according to the pathological evidence of endobronchial&#xD;
             ultrasound(EBUS) or PET-CT, the short-axis diameter of lymph node 1-2cm, and&#xD;
             considered surgically resectable at baseline by the surgical oncologist&#xD;
&#xD;
          -  Sufficient tumor histological specimens (non-cytology) for molecular marker analysis&#xD;
&#xD;
          -  At least one lesion with measurable diameter and its longest diameter is large than 10&#xD;
             mm by CT measurement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous systemic anti-tumor treatment of Non-small Cell Lung Cancer, including&#xD;
             cytotoxic drug therapy, targeted drug therapy (tyrosine kinase inhibitors or&#xD;
             monoclonal antibodies) and experimental treatment, etc&#xD;
&#xD;
          -  Previous local radiotherapy of Non-small Cell Lung Cancer&#xD;
&#xD;
          -  Be allergic to any component of Icotinib tablet (Conmana)&#xD;
&#xD;
          -  Other cancers within five years prior to the treatment of this study. Except for&#xD;
             cervical carcinoma, basal cell carcinoma and bladder epithelial neoplasm (including Ta&#xD;
             and Tis)&#xD;
&#xD;
          -  Any instable systemic disease, including: active infection, high blood pressure out of&#xD;
             control, unstable angina, onset of angina pectoris within the past 3 months,&#xD;
             congestive heart failure, myocardial infarction, severe arrhythmia, liver, kidney or&#xD;
             metabolic disease&#xD;
&#xD;
          -  Previous interstitial lung disease, drug-induced interstitial disease, radiation&#xD;
             pneumonia requiring hormone therapy or any active intersexual lung disease with&#xD;
             clinical evidence&#xD;
&#xD;
          -  Idiopathic pulmonary fibrosis detected by CT scan at baseline;&#xD;
&#xD;
          -  Not fully controlled eye inflammation or infections, or any condition that may lead to&#xD;
             the above eye diseases&#xD;
&#xD;
          -  Human immunodeficiency virus infection&#xD;
&#xD;
          -  Patients undergoing major surgery or severe trauma within 2 months prior to the first&#xD;
             use of the experimental drug&#xD;
&#xD;
          -  Patients with Small Cell Lung Cancer&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Neurological or psychiatric disorders history, including epilepsy or dementia&#xD;
&#xD;
          -  Other situations not appropriate to enter the group considering by the investigators&#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>Shugeng Gao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Hospital, Chinese Academy of Medical Science</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shugeng Gao, MD</last_name>
    <phone>13801185056</phone>
    <email>gaoshugeng@vip.sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Hospital, Chinese Academy of Medical Science</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shugeng Gao, MD</last_name>
    </contact>
    <investigator>
      <last_name>Shugeng Gao, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03749213
org study id: BD-IC-IV82
nct id: NCT03749213
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to evaluate the efficacy and safety of Icotinib as
      neoadjuvant in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially
      radical treated by surgery.
Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially
      radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times
      per day orally for 8 weeks as neoadjuvant therapy; then patients with clinical benefits
      receive surgical resection of the tumor. If there is curative effect of Icotinib according to
      the RECIST or pathological report, the patients will continue receive Icotinib for two years
      as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity. The
      primary objective of this study is evaluate the efficacy and safety of Icotinib neoadjuvant
      therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate
time frame: eight weeks
measure: R0 resection rate
time frame: eight weeks
measure: Disease Control Rate
time frame: eight weeks
measure: Decrease in cT-stage
time frame: eight weeks
measure: pathologic complete remission rate
time frame: eight weeks
measure: Time to Tumor Progression
time frame: five years after surgery
measure: Overall survival
time frame: five years after surgery
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: five years after surgery
arm group label: Icotinib
arm group type: Experimental
description: Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib as neoadjuvant therapy before surgery and adjuvant therapy or till progressive disease or unaccepted toxicity.
intervention type: Drug
intervention name: Icotinib
description: Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks as neoadjuvant therapy before surgery and for 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity.
arm group label: Icotinib
other name: Conmana
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shugeng Gao
role: Principal Investigator
affiliation: Cancer Hospital, Chinese Academy of Medical Science
last name: Shugeng Gao, MD
phone: 13801185056
email: gaoshugeng@vip.sina.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Yes