<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/NCT01683175</url>
  </required_header>
  <id_info>
    <org_study_id>ML28280</org_study_id>
    <nct_id>NCT01683175</nct_id>
  </id_info>
  <brief_title>Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation</brief_title>
  <official_title>A Prospective, Open-labelled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation NSCLC Patients With EGFR19 or 21 Exon Mutation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation&#xD;
      IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR)&#xD;
      19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2020</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>2-year disease free survival rate (DFSR)</measure>
    <time_frame>2 years</time_frame>
    <description>2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>disease free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival (OS)</measure>
    <time_frame>5 years</time_frame>
    <description>Overall survival is defined as the time from randomization to death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>5 years</time_frame>
    <description>The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event (AE)</measure>
    <time_frame>5 years</time_frame>
    <description>frequency of Adverse Event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Event (SAE)</measure>
    <time_frame>5 years</time_frame>
    <description>Frequency of Serious Adverse Event (SAE)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Non-small Cell Lung Cancer Stage III</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Erlotinib 150mg daily oral up to 2 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NP Chemotherapy for 4 cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erlotinib</intervention_name>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cis-platinum</intervention_name>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vinorelbine</intervention_name>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009,&#xD;
             confirmed by histopathology or cytology after radical operation, and having EGFR exon&#xD;
             19 deletion mutation or exon 21 L858R single base substitution;&#xD;
&#xD;
          -  Accept study adjuvant therapy within 6 weeks post radical operation;&#xD;
&#xD;
          -  ECOP PS 0-1; Life expectancy ≥12 weeks;&#xD;
&#xD;
          -  Hematology: absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count ≥100×10^9/L;&#xD;
             hemoglobin concentration ≥ 9.0 g/dL (permit to maintain hematologic criteria by blood&#xD;
             transfusion);&#xD;
&#xD;
          -  Liver Function: TBil ≤1.5xULN; ALT and AST ≤2.5xULN;&#xD;
&#xD;
          -  Renal Function: Cr ≤1.25xULN, and Ccr ≥60ml/min;&#xD;
&#xD;
          -  Female patients of childbearing potential must have a negative serum or urine&#xD;
             pregnancy test within 7 days before study treatment;&#xD;
&#xD;
          -  Signed inform consent form by patient or his/her legal representative;&#xD;
&#xD;
          -  Comply with study protocol and procedure, and be able to take oral medication; Aged&#xD;
             ≥18 years and ≦75 years;&#xD;
&#xD;
          -  Eligible patients of reproductive potential (both sexes) must agree to use a reliable&#xD;
             method of birth control before enrollment, during the study period and for at least 30&#xD;
             days after their last dose of study therapy;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having treated by Her-Target therapy, i.e. erlotinib, gefitinib, cetuximab,&#xD;
             trastuzumab;&#xD;
&#xD;
          -  Having treated by any systemic anti-tumor therapy of NSCLC, including cytotoxic&#xD;
             therapy, target medication treatment (i.e. monoclonal antibody), investigational&#xD;
             therapy;&#xD;
&#xD;
          -  Having local radiotherapy of NSCLC; Upper gastrointestinal physiological disorders, or&#xD;
             malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;&#xD;
&#xD;
          -  The findings in radical operation are lymph nodes with extracapsular invasion, or&#xD;
             fusion, or all of dissection lymph nodes positive by pathology;&#xD;
&#xD;
          -  Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment&#xD;
             (except having simple surgical resection with 5-year disease free survival,cured in&#xD;
             situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);&#xD;
&#xD;
          -  Confirmed recurrent cancer by Clinical objective evidence (pathology or radiography&#xD;
             images) before the study adjuvant therapy;&#xD;
&#xD;
          -  Known hypersensitivity to platinum, Vinorelbine, EGFR-TKI agents or relevant&#xD;
             components in the formulation;&#xD;
&#xD;
          -  Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye&#xD;
             inflammation or infection;&#xD;
&#xD;
          -  Active interstitial lung disease (ILD) by any clinical evidence; patients with any&#xD;
             co-morbidities, or motalic disorders, or any abnormal findings in physical examination&#xD;
             or laboratory tests are suspected to have contraindication of study therapy or high&#xD;
             risk of study treatment complications;&#xD;
&#xD;
          -  Any unstable systemic disease, including active infection, uncontrolled hypertension,&#xD;
             unstable angina, angina starting in latest 3 months, Congestive heart failure (NYHA ≥&#xD;
             II), myocardial infarction within 6 months prior enrollment, under medication&#xD;
             treatment of severe arrhythmia, liver, renal or metabolic disease;&#xD;
&#xD;
          -  know HIV infection Pregnant or breastfeeding women;&#xD;
&#xD;
          -  ECOG PS ≥2;&#xD;
&#xD;
          -  Mixed with small cell lung cancer;&#xD;
&#xD;
          -  Other conditions investigators evaluate that patient is not eligible to this study.&#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>Changli Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin Medical University Cancer Institute and Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The second people's hospital of Sichuan</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital</name>
      <address>
        <city>Fuzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-Sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The third affiliated hospital of Harbin Medical Univer</name>
      <address>
        <city>Harbin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The affiliated hospital of medical college Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital &amp; Institute</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hebei Provincial Tumor Hospital</name>
      <address>
        <city>Shijiazhuang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The fourth military medical university，Tangdu Hospital</name>
      <address>
        <city>Xi'an</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>October 19, 2016</last_update_submitted>
  <last_update_submitted_qc>October 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Erlotinib</keyword>
  <keyword>adjuvant therapy</keyword>
  <keyword>radical operation</keyword>
  <keyword>IIIA NSCLC</keyword>
  <keyword>EGFR mutation</keyword>
  <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>Erlotinib Hydrochloride</mesh_term>
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Vinorelbine</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/NCT01683175
org study id: ML28280
nct id: NCT01683175
lead sponsor: 
collaborator: 
has dmc: No
This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation
      IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR)
      19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 2-year disease free survival rate (DFSR)
time frame: 2 years
description: 2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year.
measure: disease free survival
time frame: 5 years
description: Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.
measure: overall survival (OS)
time frame: 5 years
description: Overall survival is defined as the time from randomization to death.
measure: Quality of Life
time frame: 5 years
description: The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS)
measure: Adverse Event (AE)
time frame: 5 years
description: frequency of Adverse Event
measure: Serious Adverse Event (SAE)
time frame: 5 years
description: Frequency of Serious Adverse Event (SAE)
arm group label: Arm 1
arm group type: Experimental
description: Erlotinib 150mg daily oral up to 2 years
arm group label: Arm 2
arm group type: Active Comparator
description: NP Chemotherapy for 4 cycles
intervention type: Drug
intervention name: Erlotinib
arm group label: Arm 1
intervention type: Drug
intervention name: cis-platinum
arm group label: Arm 2
intervention type: Drug
intervention name: Vinorelbine
arm group label: Arm 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Changli Wang
role: Principal Investigator
affiliation: Tianjin Medical University Cancer Institute and Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Erlotinib Hydrochloride
mesh term: Cisplatin
mesh term: Vinorelbine