<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/NCT02976116</url>
  </required_header>
  <id_info>
    <org_study_id>2016-013-00CH1</org_study_id>
    <nct_id>NCT02976116</nct_id>
  </id_info>
  <brief_title>A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer</brief_title>
  <official_title>Fruquintinib in Combination With Gefitinib as First-line Therapy in Patients With Advanced Non-squamous Non-small-cell Lung Cancer Harboring Activating EGFR Mutations : a Single-arm, Multicenter, Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hutchison Medipharma Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hutchmed</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced&#xD;
      non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm,&#xD;
      multicenter, phase II study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase II trial will evaluate the combination of fruquintinib and gefitinib in advanced&#xD;
      NSCLC. The endpoint will be to evaluate the efficacy and safety of the combination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">June 28, 2019</completion_date>
  <primary_completion_date type="Actual">June 28, 2019</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>tumor objective response rate</measure>
    <time_frame>Patients will be followed until study completion, an average of 1 year</time_frame>
    <description>Occurrence of completed response or partial response after treatment, assessed by RECIST 1.1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>Each patient will be followed for 30 days after the last dose</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by CTCAE v4.03</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Patients will be followed until study completion, an average of 1 year</time_frame>
    <description>The duration from first dose to first documented progression or death from any cause, whichever came first, assessed by RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration control rate (DCR)</measure>
    <time_frame>Patients will be followed until study completion, an average of 1 year</time_frame>
    <description>Occurrence of completed response, or partial response, or stable disease, assessed by RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response (TTR)</measure>
    <time_frame>Patients will be followed until study completion, an average of 1 year</time_frame>
    <description>the period from the date of first dose to the date when the criteria for complete response or partial response was first measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response （DoR）</measure>
    <time_frame>Patients will be followed until study completion, an average of 1 year</time_frame>
    <description>Duration from first documented completed response or partial response to first documented progression or death from any cause, whichever came first</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>NSCLC</condition>
  <arm_group>
    <arm_group_label>Fruquintinib &amp; Gefitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Fruquintinib and Gefitinib</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fruquintinib</intervention_name>
    <description>Fruquintinib will be administered orally once daily from Day 1 to Day 21 per 28-day cycle until disease progression or unacceptable toxicity</description>
    <arm_group_label>Fruquintinib &amp; Gefitinib</arm_group_label>
    <other_name>HMP-013</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gefitinib</intervention_name>
    <description>Gefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity</description>
    <arm_group_label>Fruquintinib &amp; Gefitinib</arm_group_label>
    <other_name>Iressa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Informed Consent Form.&#xD;
&#xD;
          -  Age between 18 to 75 years old.&#xD;
&#xD;
          -  Histologically or cytological documented stage IIIB/IV non-squamous non-small cell&#xD;
             lung cancer patients who have never received systematic treatment for the late-stage&#xD;
             disease.&#xD;
&#xD;
          -  ECOG 0-1&#xD;
&#xD;
          -  Patients must have measurable lesions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior systematic treatment for the advanced NSCLC&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &lt; 1.5×10^9 /L, or platelet count &lt; 100 ×10^9/L, or&#xD;
             hemoglobin &lt; 9 g/dL&#xD;
&#xD;
          -  Total bilirubin &gt; 1 ULN; SGOT (AST), SGPT (ALT), &gt; 1.5 ULN; for patient with liver&#xD;
             metastasis，AST or ALT &gt; 3 ULN&#xD;
&#xD;
          -  Known HIV positive&#xD;
&#xD;
          -  Hypersensitivity to either of the investigation drugs&#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>Hongyan Yin</last_name>
    <role>Study Director</role>
    <affiliation>Hutchison MediPharma Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 14, 2019</last_update_submitted>
  <last_update_submitted_qc>November 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fruquintinib</keyword>
  <keyword>NSCLC</keyword>
  <keyword>1st line</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>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/NCT02976116
org study id: 2016-013-00CH1
nct id: NCT02976116
lead sponsor: 
has dmc: No
Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced
      non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm,
      multicenter, phase II study
This phase II trial will evaluate the combination of fruquintinib and gefitinib in advanced
      NSCLC. The endpoint will be to evaluate the efficacy and safety of the combination.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: tumor objective response rate
time frame: Patients will be followed until study completion, an average of 1 year
description: Occurrence of completed response or partial response after treatment, assessed by RECIST 1.1
measure: Safety and tolerability
time frame: Each patient will be followed for 30 days after the last dose
description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
measure: Progression-free survival (PFS)
time frame: Patients will be followed until study completion, an average of 1 year
description: The duration from first dose to first documented progression or death from any cause, whichever came first, assessed by RECIST 1.1
measure: Duration control rate (DCR)
time frame: Patients will be followed until study completion, an average of 1 year
description: Occurrence of completed response, or partial response, or stable disease, assessed by RECIST 1.1
measure: Time to response (TTR)
time frame: Patients will be followed until study completion, an average of 1 year
description: the period from the date of first dose to the date when the criteria for complete response or partial response was first measured
measure: Duration of response （DoR）
time frame: Patients will be followed until study completion, an average of 1 year
description: Duration from first documented completed response or partial response to first documented progression or death from any cause, whichever came first
arm group label: Fruquintinib & Gefitinib
arm group type: Experimental
description: Drug: Fruquintinib and Gefitinib
intervention type: Drug
intervention name: Fruquintinib
description: Fruquintinib will be administered orally once daily from Day 1 to Day 21 per 28-day cycle until disease progression or unacceptable toxicity
arm group label: Fruquintinib & Gefitinib
other name: HMP-013
intervention type: Drug
intervention name: Gefitinib
description: Gefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity
arm group label: Fruquintinib & Gefitinib
other name: Iressa
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hongyan Yin
role: Study Director
affiliation: Hutchison MediPharma Ltd
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Gefitinib
sharing ipd: No