<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/NCT02967497</url>
  </required_header>
  <id_info>
    <org_study_id>2016-02-003C</org_study_id>
    <nct_id>NCT02967497</nct_id>
  </id_info>
  <brief_title>Clinical Study of YQ1 Plus Cisplatin-based Chemotherapy in Advanced NSCLC EGFR Wild Type</brief_title>
  <official_title>An Open Label Study of UanQiHuoLi Tang Plus Cisplatin-based Chemotherapy in Advanced Epidermal Growth Factor Receptor Wild Type Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with&#xD;
      cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK&#xD;
      wild type non-small cell lung cancer, stage IIIB-IV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with&#xD;
      cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK&#xD;
      wild type non-small cell lung cancer, stage IIIB-IV. Chinese herbal medicine was known to be&#xD;
      beneficial adjuvant or alternative medicine for cancer treatment. However, the mechanism was&#xD;
      unknown. This study wants to investigate the effect and mechanism of YQ1, which was proved to&#xD;
      improve the antitumor immunity, to inhibit cancer progression, and to prolong overall&#xD;
      survival of lung adenocarcinoma in a series of preclinical studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Blank</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention, just observation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>YQ1 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cisplatin-based chemotherapy + YQ1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>YQ1</intervention_name>
    <description>Oral administered powder</description>
    <arm_group_label>YQ1 group</arm_group_label>
    <other_name>a herbal medicine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is&#xD;
             advanced/metastatic (stage IIIB/IV), EGFR/ALK wild type.&#xD;
&#xD;
          -  Subjects who plan to receive cisplatin-based chemotherapy.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign an Institutional Review Board&#xD;
             (IRB)-approved informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ECOG performance status &gt;= 3&#xD;
&#xD;
          -  WBC =&lt; 4,000 cells/μl, ANC =&lt; 1,500/mcL, Platelets =&lt; 100,000/mcL , Hemoglobin =&lt; 9&#xD;
             g/dL,&#xD;
&#xD;
          -  Total bilirubin &gt;= 1.5 x upper limit of normal (ULN), AST &gt;= 1.5x ULN, ALT &gt;= 2.5 x&#xD;
             ULN, Creatinine &gt;= 1.5x ULN&#xD;
&#xD;
          -  Current uncontrolled cardiac disease such as angina or myocardial infarction,&#xD;
             congestive heart failure.&#xD;
&#xD;
          -  Chronic or current Inflammatory Bowel Disease, post-surgery of intestine, Lynch&#xD;
             syndrome, FAP, Peutz-Jegher.&#xD;
&#xD;
          -  History of allergic reactions cisplatin&#xD;
&#xD;
          -  Pregnant women are excluded; breastfeeding should be discontinued prior to study&#xD;
             entry.&#xD;
&#xD;
          -  Received any other clinical trail at the same time.&#xD;
&#xD;
          -  Current dementia or other cognitive disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chemotherapy</keyword>
  <keyword>Herbal medicine</keyword>
  <keyword>Lung cancer</keyword>
  <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>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/NCT02967497
org study id: 2016-02-003C
nct id: NCT02967497
lead sponsor: 
collaborator: 
has dmc: No
This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with
      cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK
      wild type non-small cell lung cancer, stage IIIB-IV.
This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with
      cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK
      wild type non-small cell lung cancer, stage IIIB-IV. Chinese herbal medicine was known to be
      beneficial adjuvant or alternative medicine for cancer treatment. However, the mechanism was
      unknown. This study wants to investigate the effect and mechanism of YQ1, which was proved to
      improve the antitumor immunity, to inhibit cancer progression, and to prolong overall
      survival of lung adenocarcinoma in a series of preclinical studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Progression-free survival (PFS)
time frame: 1 year
arm group label: Blank
arm group type: No Intervention
description: No intervention, just observation.
arm group label: YQ1 group
arm group type: Experimental
description: Cisplatin-based chemotherapy + YQ1
intervention type: Drug
intervention name: YQ1
description: Oral administered powder
arm group label: YQ1 group
other name: a herbal medicine
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No