<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/NCT02974933</url>
  </required_header>
  <id_info>
    <org_study_id>HubeiCH</org_study_id>
    <nct_id>NCT02974933</nct_id>
  </id_info>
  <brief_title>Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer</brief_title>
  <official_title>Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer ：Single Arm Exploratory Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuling Ou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hubei Clinical Research Collaboration Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hubei Cancer Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with&#xD;
      pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line&#xD;
      of treatment of progression-free survival&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a one-arm study. The progression-free survival will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</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>progression free survival</measure>
    <time_frame>4 weeks</time_frame>
    <description>evaluation per 28 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>4 weeks</time_frame>
    <description>evaluation per 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease control rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>evaluation per 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>objective response rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>evaluation per 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event</measure>
    <time_frame>4 weeks</time_frame>
    <description>evaluation per 28 days</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Nonsmall Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>apatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>combined with pemetrexed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib combined with pemetrexed</intervention_name>
    <description>For those pretreated non-squamous non-small cell lung cancer, treat with apatinib 500mg Qd, po.combined with pemetrexed continue until disease progression</description>
    <arm_group_label>apatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged from 18 years to 70years.&#xD;
&#xD;
          2. Histologically or cytologically confirmed non-squamous non-small cell lung&#xD;
             cancer(stage IIIB/IV).&#xD;
&#xD;
          3. Measurable lesions as defined by RECIST criteria.&#xD;
&#xD;
          4. Locally advanced lung cancer cannot treat with surgery, recurrent or metastatic lung&#xD;
             cancer&#xD;
&#xD;
          5. ECOG performance status (PS) of 0 to 1.&#xD;
&#xD;
          6. Life expectancy ≥3 months.&#xD;
&#xD;
          7. Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.&#xD;
&#xD;
          2. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been&#xD;
             definitively treated with surgery and/or radiation.&#xD;
&#xD;
          3. Tumor invade big vessels or close to big vessels (less than 5mm)&#xD;
&#xD;
          4. Obvious cavity or necrosis formed in the tumor&#xD;
&#xD;
          5. Uncontrolled hypertension&#xD;
&#xD;
          6. Myocardial ischemia or infarction more than stage II, cardiac insufficiency.&#xD;
&#xD;
          7. Abnormal coagulation (INR&gt;1.5 or PT&gt;ULN+4, or APTT&gt;1.5 ULN), bleeding tendency or&#xD;
             receiving coagulation therapy&#xD;
&#xD;
          8. The active HBV or HCV infection&#xD;
&#xD;
          9. History of other malignancies except cured basal cell carcinoma of skin and carcinoma&#xD;
             in-situ of uterine cervix.&#xD;
&#xD;
         10. Hemoptysis, more than 2.5ml daily&#xD;
&#xD;
         11. Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous&#xD;
             thrombosis.&#xD;
&#xD;
         12. Unhealed bone fracture or wound for long time&#xD;
&#xD;
         13. Received big surgery, had bone fracture or ulcer in 4 weeks.&#xD;
&#xD;
         14. Urine protein≥++, or urine protein in 24 hours≥1.0g&#xD;
&#xD;
         15. Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to&#xD;
             enrollment&#xD;
&#xD;
         16. Have received prior treatment with VEGFR TKI (Bevacizumab is permitted).&#xD;
&#xD;
         17. Pregnant or lactating woman, or woman unwilling to practice contraception during the&#xD;
             study.&#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_contact>
    <last_name>Ou Wu Ling, MD</last_name>
    <email>609700817@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ou wuling</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ou Wu ling, 40</last_name>
      <phone>13469989766</phone>
      <phone_ext>86</phone_ext>
      <email>609700817@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>February 15, 2017</last_update_submitted>
  <last_update_submitted_qc>February 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hubei Cancer Hospital</investigator_affiliation>
    <investigator_full_name>Wuling Ou</investigator_full_name>
    <investigator_title>Deputy Chief Physician</investigator_title>
  </responsible_party>
  <keyword>apatinib</keyword>
  <keyword>pemetrexed</keyword>
  <keyword>NSCLC</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Apatinib</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/NCT02974933
org study id: HubeiCH
nct id: NCT02974933
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with
      pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line
      of treatment of progression-free survival
It is a one-arm study. The progression-free survival will be evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression free survival
time frame: 4 weeks
description: evaluation per 28 days
measure: Overall Survival
time frame: 4 weeks
description: evaluation per 28 days
measure: disease control rate
time frame: 4 weeks
description: evaluation per 28 days
measure: objective response rate
time frame: 4 weeks
description: evaluation per 28 days
measure: Adverse Event
time frame: 4 weeks
description: evaluation per 28 days
arm group label: apatinib
arm group type: Experimental
description: combined with pemetrexed
intervention type: Drug
intervention name: Apatinib combined with pemetrexed
description: For those pretreated non-squamous non-small cell lung cancer, treat with apatinib 500mg Qd, po.combined with pemetrexed continue until disease progression
arm group label: apatinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ou Wu Ling, MD
email: 609700817@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Hubei Cancer Hospital
investigator full name: Wuling Ou
investigator title: Deputy Chief Physician
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Pemetrexed
mesh term: Apatinib
sharing ipd: No