<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/NCT03002844</url>
  </required_header>
  <id_info>
    <org_study_id>ShanghaiPH002</org_study_id>
    <nct_id>NCT03002844</nct_id>
  </id_info>
  <brief_title>EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism</brief_title>
  <official_title>EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Pulmonary Hospital, Shanghai, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Pulmonary Hospital, Shanghai, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in&#xD;
      patients who had NSCLC with EGFR mutations. In the study, the investigators want to use&#xD;
      EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients&#xD;
      with both EGFR mutation and BIM deletion polymorphism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients&#xD;
      who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with&#xD;
      chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and&#xD;
      BIM deletion polymorphism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progress Free Survival</measure>
    <time_frame>up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Safety</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Nonsmall Cell Lung Cancer</condition>
  <condition>EGFR Gene Mutation</condition>
  <arm_group>
    <arm_group_label>EGFR-TKI and Chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>gefitinib with pemetrexed/gemcitabine and carboplatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EGFR-TK Inhibitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gefitinib</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EGFR-TK Inhibitor</intervention_name>
    <description>EGFR-TKI (gefitinib 250mg per day)</description>
    <arm_group_label>EGFR-TK Inhibitor</arm_group_label>
    <other_name>gefitinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EGFR-TKI</intervention_name>
    <description>EGFR-TKI (gefitinib 250mg per day)</description>
    <arm_group_label>EGFR-TKI and Chemotherapy</arm_group_label>
    <other_name>gefitinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EGFR-TKI and Chemotherapy</intervention_name>
    <description>pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w</description>
    <arm_group_label>EGFR-TKI and Chemotherapy</arm_group_label>
    <other_name>EGFR-TKI and pemetrexed/gemcitabine and carboplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent&#xD;
&#xD;
          2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or&#xD;
             metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)&#xD;
&#xD;
          3. Must have measurable or non-measurable disease&#xD;
&#xD;
          4. Must be able to comply with study and follow-up procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Small cell, carcinoid, or mixed small cell lung cancer&#xD;
&#xD;
          2. Malignancies within 3 years except for adequately treated carcinoma in situ of the&#xD;
             cervix or basal or squamous cell skin cancer&#xD;
&#xD;
          3. Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC&#xD;
&#xD;
          4. Unstable systemic disease, including active infection, uncontrolled hypertension,&#xD;
             unstable angina, congestive heart failure, or myocardial infarction within 6 months&#xD;
             prior to Day 1, or serious cardiac arrhythmia requiring medication&#xD;
&#xD;
          5. History of other diseases, metabolic dysfunction, physical examination finding, or&#xD;
             clinical laboratory finding giving reasonable suspicion of a disease or condition that&#xD;
             contraindicates the use of an investigational drug or that might affect the&#xD;
             interpretation of the results of the study or render the patient at high risk from&#xD;
             treatment complications&#xD;
&#xD;
          6. Gastrointestinal tract disease resulting in an inability to take oral medication or a&#xD;
             requirement for intravenous (IV) alimentation, or prior surgical procedures affecting&#xD;
             absorption&#xD;
&#xD;
          7. Pregnancy or lactation&#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>Caicun Zhou, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Pulmonary Hospital, Tongji University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Caicun Zhou, MD PHD</last_name>
    <phone>8613301825532</phone>
    <email>caicunzhoudr@163.com</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>December 25, 2016</last_update_submitted>
  <last_update_submitted_qc>December 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Pulmonary Hospital, Shanghai, China</investigator_affiliation>
    <investigator_full_name>Caicun Zhou</investigator_full_name>
    <investigator_title>Director Head of Medical Oncology, Principal Investigator, Clinical Professor</investigator_title>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Gefitinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03002844
org study id: ShanghaiPH002
nct id: NCT03002844
lead sponsor: 
has dmc: Yes
BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in
      patients who had NSCLC with EGFR mutations. In the study, the investigators want to use
      EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients
      with both EGFR mutation and BIM deletion polymorphism.
BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients
      who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with
      chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and
      BIM deletion polymorphism.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progress Free Survival
time frame: up to 12 months
measure: Overall Survival
time frame: up to 24 months
measure: Overall Response Rate
time frame: up to 12 months
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
time frame: up to 12 months
description: Safety
arm group label: EGFR-TKI and Chemotherapy
arm group type: Experimental
description: gefitinib with pemetrexed/gemcitabine and carboplatin
arm group label: EGFR-TK Inhibitor
arm group type: Experimental
description: Gefitinib
intervention type: Drug
intervention name: EGFR-TK Inhibitor
description: EGFR-TKI (gefitinib 250mg per day)
arm group label: EGFR-TK Inhibitor
other name: gefitinib
intervention type: Drug
intervention name: EGFR-TKI
description: EGFR-TKI (gefitinib 250mg per day)
arm group label: EGFR-TKI and Chemotherapy
other name: gefitinib
intervention type: Drug
intervention name: EGFR-TKI and Chemotherapy
description: pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w
arm group label: EGFR-TKI and Chemotherapy
other name: EGFR-TKI and pemetrexed/gemcitabine and carboplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Caicun Zhou, MD, PHD
role: Principal Investigator
affiliation: Shanghai Pulmonary Hospital, Tongji University
last name: Caicun Zhou, MD PHD
phone: 8613301825532
email: caicunzhoudr@163.com
responsible party type: Principal Investigator
investigator affiliation: Shanghai Pulmonary Hospital, Shanghai, China
investigator full name: Caicun Zhou
investigator title: Director Head of Medical Oncology, Principal Investigator, Clinical Professor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Carboplatin
mesh term: Gemcitabine
mesh term: Pemetrexed
mesh term: Gefitinib
sharing ipd: No