<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/NCT03768037</url>
  </required_header>
  <id_info>
    <org_study_id>CTONG1801</org_study_id>
    <nct_id>NCT03768037</nct_id>
  </id_info>
  <brief_title>Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (&gt;=70) or PS=2 Non-squamous NSCLC</brief_title>
  <official_title>A Study to Evaluate the Efficacy and Safety of Anlotinib Plus Pemetrexed as the 1-line Treatment of Patients With Platinum Intolerant Advanced Non-squamous NSCLC, With Pemetrexed Control.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Association of Clinical Trials</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Association of Clinical Trials</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the efficacy and safety of Anlotinib plus Pemetrexed as the 1-line treatment of&#xD;
      patients with Platinum intolerant advanced non-squamous NSCLC, with Pemetrexed control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug&#xD;
      Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing&#xD;
      Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with&#xD;
      multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">November 26, 2018</start_date>
  <completion_date type="Anticipated">November 26, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 26, 2019</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients alive and progression free at 6 months (APF6)</measure>
    <time_frame>Estimated to be from baseline up to 2 years</time_frame>
    <description>the number (%) of patients who are alive and progression free per RECIST 1.1 at 6 months after randomization per Kaplan-Meier estimate of progression free survival at 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival(PFS)</measure>
    <time_frame>Estimated to be from baseline up to 2 years</time_frame>
    <description>the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival(OS)</measure>
    <time_frame>Estimated to be from baseline up to 2 years</time_frame>
    <description>the time from randomization to death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate(DCR)</measure>
    <time_frame>Estimated to be from baseline up to 2 years</time_frame>
    <description>the total proportion of patients who demonstrate a response(complete responses + partial responses + stable disease ) to treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate(ORR)</measure>
    <time_frame>Estimated to be from baseline up to 2 years</time_frame>
    <description>the total proportion of patients who demonstrate a response(complete responses + partial responses) to treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">106</enrollment>
  <condition>Advanced Non-squamous NSCLC</condition>
  <arm_group>
    <arm_group_label>Anlotinib plus Pemetrexed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anlotinib plus Pemetrexed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pemetrexed</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Pemetrexed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anlotinib plus Pemetrexed</intervention_name>
    <description>Anlotinib p.o, qd and it should be continued until disease progress or unacceptable toxic effects.&#xD;
Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects</description>
    <arm_group_label>Anlotinib plus Pemetrexed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <description>Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects</description>
    <arm_group_label>Pemetrexed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥70 years old and ECOG PS=0-2 or ≥18 years old and ECOG PS=2&#xD;
&#xD;
          -  Diagnosed with advanced or recurrent non-squamous NSCLC (phase IIIB/IV) through&#xD;
             pathology, with measurable nidus(using RECIST 1.1)&#xD;
&#xD;
          -  No prior systemic treatment for non-squamous NSCLC&#xD;
&#xD;
          -  Negative in EGFR&amp;ALK&amp;ROS1&#xD;
&#xD;
          -  Main organs function is normal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any habitus or medical history of hemorrhage, however severe it is; the patients&#xD;
             who have non healing wounds, ulcer or fracture after any events with hemorrhage or&#xD;
             bleeding&#xD;
&#xD;
          -  Symptoms of brain metastases cannot be controlled and treated within less than 21 days&#xD;
&#xD;
          -  Have participated in other clinical trials of anti-tumor medicine within 4 weeks&#xD;
&#xD;
          -  Get any severe diseases or the ones that cannot be controlled&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiaoqing Liu</last_name>
    <phone>86-010-89509324</phone>
    <email>liuxiaoqing@csco.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shucai Zhang</last_name>
    <phone>86-010-89509324</phone>
    <email>sczhang6304@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Chest Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>101149</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shucai Zhang</last_name>
      <phone>86-010-89509324</phone>
      <email>sczhang6304@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhe Liu</last_name>
      <phone>86-010-89509323</phone>
      <email>liuzhe1968@aliyun.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</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>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>
  </intervention_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/NCT03768037
org study id: CTONG1801
nct id: NCT03768037
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evaluate the efficacy and safety of Anlotinib plus Pemetrexed as the 1-line treatment of
      patients with Platinum intolerant advanced non-squamous NSCLC, with Pemetrexed control.
Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug
      Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing
      Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with
      multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients alive and progression free at 6 months (APF6)
time frame: Estimated to be from baseline up to 2 years
description: the number (%) of patients who are alive and progression free per RECIST 1.1 at 6 months after randomization per Kaplan-Meier estimate of progression free survival at 6 months.
measure: Progression Free Survival(PFS)
time frame: Estimated to be from baseline up to 2 years
description: the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
measure: Overall Survival(OS)
time frame: Estimated to be from baseline up to 2 years
description: the time from randomization to death from any cause
measure: Disease Control Rate(DCR)
time frame: Estimated to be from baseline up to 2 years
description: the total proportion of patients who demonstrate a response(complete responses + partial responses + stable disease ) to treatment
measure: Objective Response Rate(ORR)
time frame: Estimated to be from baseline up to 2 years
description: the total proportion of patients who demonstrate a response(complete responses + partial responses) to treatment
arm group label: Anlotinib plus Pemetrexed
arm group type: Experimental
description: Anlotinib plus Pemetrexed
arm group label: Pemetrexed
arm group type: Other
description: Pemetrexed
intervention type: Drug
intervention name: Anlotinib plus Pemetrexed
description: Anlotinib p.o, qd and it should be continued until disease progress or unacceptable toxic effects.
Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects
arm group label: Anlotinib plus Pemetrexed
intervention type: Drug
intervention name: Pemetrexed
description: Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects
arm group label: Pemetrexed
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Xiaoqing Liu
phone: 86-010-89509324
email: liuxiaoqing@csco.org.cn
last name: Shucai Zhang
phone: 86-010-89509324
email: sczhang6304@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Pemetrexed