<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/NCT03256721</url>
  </required_header>
  <id_info>
    <org_study_id>SECGOLC003</org_study_id>
    <nct_id>NCT03256721</nct_id>
  </id_info>
  <brief_title>Compare Apatinib Plus Chemotherapy Drug Versus Chemotherapy Drug as Second-line Treatment in NSCLC</brief_title>
  <official_title>A Randomized, Parallel Control, Exploratory Trial to Compare Apatinib Plus Chemotherapy Drug Versus Chemotherapy Drug as Second-line Treatment in Subjects With Advanced or Metastatic of the Non-small Cell Lung Cancer (NSCLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuzhou General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fuzhou General Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor&#xD;
      activity in the patients with GC. The purpose of this study is to determine whether apatinib&#xD;
      plus chemotherapy drug can improve progression free survival compared with chemotherapy drug&#xD;
      in patients with metastatic the non-small cell lung cancer who failed one lines of&#xD;
      chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lung cancer is the leading cause of cancer death in world wild, especially non-small cell&#xD;
      lung cancer (NSCLC). Detection and early intervention are difficult because pathogenesis of&#xD;
      NSCLC is not yet entirely clear.Most of them are advanced or metastatic patients, so approach&#xD;
      3/4 NSCLC undergo chemotherapy. Fewer treatment options exist on NSCLC whom is wild type of&#xD;
      EGFR. The patient did not benefit from the existing treatment regimen after first-line&#xD;
      treatment. There is currently no effective drug to treat this group of patients.&#xD;
&#xD;
      Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor&#xD;
      activity in the patients with GC. The purpose of this study is to determine whether apatinib&#xD;
      plus chemotherapy drug can improve progression free survival compared with chemotherapy drug&#xD;
      in patients with metastatic the non-small cell lung cancer who failed one lines of&#xD;
      chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to the enrollment was slow and exceeded the expected enrollment time&#xD;
  </why_stopped>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">August 16, 2019</completion_date>
  <primary_completion_date type="Actual">March 27, 2019</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>
    <intervention_model_description>Group A: Apatinib 500mg QD PO d1-21 + Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d&#xD;
Group B: Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>To compare progression-free survival (PFS) in subjects treated with apatinib plus chemotherapy drug versus chemotherapy drug as a second-line treatment in whom with advanced or metastatic non-small cell lung cancer (NSCLC)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Nonsmall Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Apatinib+docetaxel/pemetrexed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apatinib 500mg QD PO d1-21+docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>docetaxel/pemetrexed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib/docetaxel/pemetrexed</intervention_name>
    <description>Participants are randomly assigned to treatment group or control group</description>
    <arm_group_label>Apatinib+docetaxel/pemetrexed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>docetaxel/pemetrexed</intervention_name>
    <description>Participants are randomly assigned to treatment group or control group</description>
    <arm_group_label>docetaxel/pemetrexed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age：18~75 years;&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          3. Subjects with histologically or cytologically confirmed locally advanced or advanced&#xD;
             NSCLC who have previously received no more than one lines treatment before&#xD;
             participating；&#xD;
&#xD;
          4. Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which&#xD;
             is confirmed by computed tomography (CT) scan or MRI .&#xD;
&#xD;
          5. EGFRˉ,and ALK mutation in the negative or unknown；&#xD;
&#xD;
          6. Subjects without brain metastases or asymptomatic brain metastases, and not needing&#xD;
             for dehydrating agents or corticosteroids to control intracranial symptoms;&#xD;
&#xD;
          7. Survival expectation≥ 3 months;&#xD;
&#xD;
          8. The main organ function is normal;&#xD;
&#xD;
          9. Females of childbearing potential must be a pregnancy test in 7 days before&#xD;
             participating ( including serum or urine), and the results were negative.&#xD;
&#xD;
         10. Subjects provided written informed consent before participating,Willing and able to&#xD;
             comply with all aspects of the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Small Cell Lung Cancer;&#xD;
&#xD;
          2. Subjects with symptomatic brain metastases;&#xD;
&#xD;
          3. Survival expectation &lt; 3 months;&#xD;
&#xD;
          4. Blood transfusion is required in the first dose of drug treatment within 14 days ;&#xD;
&#xD;
          5. The interval of subjects had received chemotherapy, biotherapy, radiotherapy or other&#xD;
             anticancer therapies in the first dose of drug treatment within 21 days(excluding&#xD;
             palliative radiotherapy);&#xD;
&#xD;
          6. The risk of active bleeding;&#xD;
&#xD;
          7. Subjects with uncontrolled blood pressure with medication (140/90 mmHg)&#xD;
&#xD;
          8. Laboratory values and organ functions ： （1）Hematologic insufficiency:&#xD;
&#xD;
               1. Hemoglobin (Hb)&lt;8.5 g/dL，&#xD;
&#xD;
               2. Absolute neutrophil count (ANC)≤1.5×109/L，&#xD;
&#xD;
               3. Platelet count (PLT)&lt; 100×109/L； （2）Insufficient liver function:&#xD;
&#xD;
               1. Bilirubin &gt; 1.5×the upper limit of normal (ULN)&#xD;
&#xD;
               2. Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) &gt;3.0×(ULN),&#xD;
                  When liver metastases,Bilirubin &gt; 1.5×ULN, ALT or AST &gt;5.0×(ULN.&#xD;
&#xD;
               3. serum creatinine ≤1.0×（ULN）, or creatinine clearance &gt; 50 mL/min( calculated per&#xD;
                  the Cockcroft and Gault formula) (3) Subjects with positive for HBV&#xD;
                  surfaceantigen ( HBsAg)or anti-hcv (4)Subjects with Interstitial lung disease&#xD;
                  (5)Insufficient renal function: serum creatinine≥ 1.5×（ULN）, or creatinine&#xD;
                  clearance &lt;60 mL/min&#xD;
&#xD;
          9. impairment of heart function: (1)Left ventricular ejection fraction (LVEF) &lt;45% (LVEF&#xD;
             evaluation is not required for subjects have no history of congestive heart failure),&#xD;
             (2)Unstable angina, (3)Severe arrhythmia, (4)NYHA III or IVgrade of congestive heart&#xD;
             failure, (5) Subjects with miocardial infarction within the last 12 months before&#xD;
             entering the trial, (6)Pericardial effusion,&#xD;
&#xD;
         10. Subjects with liver fibrosis or hepatic cirrhosis&#xD;
&#xD;
         11. (1)Subjects with other active malignancy (except for definitively treated non melanoma&#xD;
             skin cancer,carcinoma in-situ of the cervix,or other cancers that are treated with&#xD;
             curative treatment and have no signs of recurrence for at least 5 years ) ,&#xD;
             (2)Subjects with dysphagia,malabsorption,chronic gastrointestinal diseases,or other&#xD;
             medical history may hinder compliance and / or experimental drug absorption,&#xD;
&#xD;
         12. Subjects with major surgery in the first dose of drug treatment within 28 days,&#xD;
&#xD;
         13. Subjects with positive foknown human immunodeficiency virus。&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fuzhou general hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>365000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>apatinib docetaxel pemetrexed</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>Docetaxel</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Apatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03256721
org study id: SECGOLC003
nct id: NCT03256721
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor
      activity in the patients with GC. The purpose of this study is to determine whether apatinib
      plus chemotherapy drug can improve progression free survival compared with chemotherapy drug
      in patients with metastatic the non-small cell lung cancer who failed one lines of
      chemotherapy.
Lung cancer is the leading cause of cancer death in world wild, especially non-small cell
      lung cancer (NSCLC). Detection and early intervention are difficult because pathogenesis of
      NSCLC is not yet entirely clear.Most of them are advanced or metastatic patients, so approach
      3/4 NSCLC undergo chemotherapy. Fewer treatment options exist on NSCLC whom is wild type of
      EGFR. The patient did not benefit from the existing treatment regimen after first-line
      treatment. There is currently no effective drug to treat this group of patients.

      Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor
      activity in the patients with GC. The purpose of this study is to determine whether apatinib
      plus chemotherapy drug can improve progression free survival compared with chemotherapy drug
      in patients with metastatic the non-small cell lung cancer who failed one lines of
      chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group A: Apatinib 500mg QD PO d1-21 + Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d
Group B: Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: progression-free survival
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
description: To compare progression-free survival (PFS) in subjects treated with apatinib plus chemotherapy drug versus chemotherapy drug as a second-line treatment in whom with advanced or metastatic non-small cell lung cancer (NSCLC)
arm group label: Apatinib+docetaxel/pemetrexed
arm group type: Experimental
description: Apatinib 500mg QD PO d1-21+docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d
arm group label: docetaxel/pemetrexed
arm group type: Active Comparator
description: docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d
intervention type: Drug
intervention name: Apatinib/docetaxel/pemetrexed
description: Participants are randomly assigned to treatment group or control group
arm group label: Apatinib+docetaxel/pemetrexed
intervention type: Drug
intervention name: docetaxel/pemetrexed
description: Participants are randomly assigned to treatment group or control group
arm group label: docetaxel/pemetrexed
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Docetaxel
mesh term: Pemetrexed
mesh term: Apatinib
sharing ipd: Undecided