<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/NCT02256852</url>
  </required_header>
  <id_info>
    <org_study_id>QBKPN-01</org_study_id>
    <nct_id>NCT02256852</nct_id>
  </id_info>
  <brief_title>Exploratory Study of QBKPN SSI in Non-Small Cell Lung Cancer</brief_title>
  <official_title>Open Label,Single Arm,Exploratory Study to Evaluate the Safety,Tolerability,Compliance and MOA,of QBKPN SSI in Subjects With 2 or More Second Primary Pre-invasive/Invasive Adenocarcinoma Following Surgical Resection of Stage I NSCLC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qu Biologics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qu Biologics Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety, tolerability, compliance and mechanism&#xD;
      of action of study drug (QBKPN SSI) in subjects with two or more second primary pre-invasive&#xD;
      or invasive adenocarcinoma following surgical section of Stage 1 NSCLC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Please refer to summary above.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 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>Safety, tolerability and compliance variables</measure>
    <time_frame>16 weeks</time_frame>
    <description>Assess the number of adverse events and subject reported data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exploratory variables</measure>
    <time_frame>16 weeks</time_frame>
    <description>Assess and identify biomarkers associated with immune response</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>QBKPN SSI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individualized maintenance dose administered subcutaneously for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>QBKPN SSI</intervention_name>
    <description>QBKPN SSI is administered subcutaneously for 12 weeks</description>
    <arm_group_label>QBKPN SSI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female who is at or above the age of consent&#xD;
&#xD;
          -  Histologically confirmed original diagnosis of lung cancer&#xD;
&#xD;
          -  Life expectancy greater than 12 months&#xD;
&#xD;
          -  ECOG performance status 0, 1, or 2 at screening&#xD;
&#xD;
          -  Female subjects who agree to practice two effective methods of contraception from the&#xD;
             time of signing the informed consent form through one month after the last dose of&#xD;
             study drug&#xD;
&#xD;
          -  Male subjects who agree to practice effective barrier contraception during the entire&#xD;
             study drug period and through one month after the last dose of study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Extra-thoracic lung cancer progression&#xD;
&#xD;
          -  Any active malignancies&#xD;
&#xD;
          -  Any uncontrolled or major organ dysfunction&#xD;
&#xD;
          -  Any past or current radiation or systemic therapies for the treatment of lung cancer&#xD;
&#xD;
          -  Known HIV infection or other immunosuppressive disorder&#xD;
&#xD;
          -  Concurrently participating in another study with an investigational immunotherapy or&#xD;
             have received investigational immunotherapy within 3 months prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Stephen Lam</last_name>
    <role>Principal Investigator</role>
    <affiliation>British Columbia Cancer Agency</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BC Cancer Research Centre</name>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>February 18, 2016</last_update_submitted>
  <last_update_submitted_qc>February 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 22, 2016</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>
  <!-- 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/NCT02256852
org study id: QBKPN-01
nct id: NCT02256852
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety, tolerability, compliance and mechanism
      of action of study drug (QBKPN SSI) in subjects with two or more second primary pre-invasive
      or invasive adenocarcinoma following surgical section of Stage 1 NSCLC.
Please refer to summary above.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety, tolerability and compliance variables
time frame: 16 weeks
description: Assess the number of adverse events and subject reported data
measure: Exploratory variables
time frame: 16 weeks
description: Assess and identify biomarkers associated with immune response
arm group label: QBKPN SSI
arm group type: Experimental
description: Individualized maintenance dose administered subcutaneously for 12 weeks
intervention type: Biological
intervention name: QBKPN SSI
description: QBKPN SSI is administered subcutaneously for 12 weeks
arm group label: QBKPN SSI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr. Stephen Lam
role: Principal Investigator
affiliation: British Columbia Cancer Agency
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung