<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/NCT03755869</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF2018LSK-073</org_study_id>
    <nct_id>NCT03755869</nct_id>
  </id_info>
  <brief_title>Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line（ALTER-L020）</brief_title>
  <official_title>An Open, Single-arm, Multi-center Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tang-Du Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yan'an University Affiliated Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and&#xD;
      development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and&#xD;
      tumor celltebiz related kinase -c-Kit kinase. In the phase III study, Patients who failed at&#xD;
      least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were&#xD;
      treated with anlotinib (12mg, po. qd. on day 1to14 of a 21-day cycle) or placebo, the&#xD;
      anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS&#xD;
      were 1.4 months and 6.3 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is an open, single-arm, multi-center clinical trial conducted in China, and plan to&#xD;
      Recruiting103 patients who were progressed after first line systemic therapy and&#xD;
      refused/can't tolerate chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to&#xD;
      14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">November 2021</primary_completion_date>
  <phase>Phase 4</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>Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1</measure>
    <time_frame>Baseline until PD or death, whichever occurs first (up to approximately 24 months)</time_frame>
    <description>Progress free survival (PFS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Overall Survival (OS) as Assessed by the Investigator Using RECIST v1.1</measure>
    <time_frame>Baseline until death from any cause (up to approximately 24 months)</time_frame>
    <description>Overall Survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)as Assessed by the Investigator Using RECIST v1.1</measure>
    <time_frame>First occurrence of PR or CR until PD or death, whichever occurs first (up to 24 months)</time_frame>
    <description>Disease Control Rate (DCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1</measure>
    <time_frame>Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to 24 months)</time_frame>
    <description>Objective Response Rate (ORR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Adverse Events</measure>
    <time_frame>Baseline until up to 21 days after end of treatment</time_frame>
    <description>Percentage of Participants with Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">103</enrollment>
  <condition>Non-squamous NSCLC</condition>
  <arm_group>
    <arm_group_label>Anlotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anlotinib</intervention_name>
    <description>Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.</description>
    <arm_group_label>Anlotinib</arm_group_label>
    <other_name>AL3818</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated informed consent&#xD;
&#xD;
          -  Age：18~75 years;&#xD;
&#xD;
          -  Subjects with histologically or cytologically confirmed locally advanced and/or&#xD;
             advanced NSCLC&#xD;
&#xD;
          -  at least two systematic chemotherapy with upwards of 1-line treatments or cannot&#xD;
             suffer&#xD;
&#xD;
          -  The negative patients in EGFR&amp;ALK can participate or who positive in EGFR&amp;ALK, have or&#xD;
             have not drug tolerance after the treatment with relative targeted drugs&#xD;
&#xD;
          -  Subjects with at least one measurable lesion as defined by RECIST (version 1.1)&#xD;
&#xD;
          -  Expected Survival Time: Over 3 months&#xD;
&#xD;
          -  ECOG PS：0-1,&#xD;
&#xD;
          -  main organs function is normal&#xD;
&#xD;
          -  The woman patients of childbearing age who must agree to take contraceptive methods&#xD;
             (e.g. intrauterine device, contraceptive pill or condom) during the research and&#xD;
             within another 6 months after it; who are not in the lactation period and examined as&#xD;
             negative in blood serum test or urine pregnancy test within 7 days before the&#xD;
             research; The man patients who must agree to take contraceptive methods during the&#xD;
             research and within another 6 months after it&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed&#xD;
             with non-small cell cancer)&#xD;
&#xD;
          -  lung squamous carcinoma&#xD;
&#xD;
          -  Other active malignancies requiring treatment&#xD;
&#xD;
          -  History of malignancy&#xD;
&#xD;
          -  Have got non remissive toxic reactions derived from previous therapies, which is over&#xD;
             level 1 in CTC AE (4.0), alopecia NOT included&#xD;
&#xD;
          -  Abnormal coagulation (INR&gt;1.5 or PT&gt;ULN+4s or APTT &gt;1.5 ULN); Patients with any&#xD;
             physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation&#xD;
&#xD;
          -  take major surgical treatments or have serious trauma before grouping, or the impact&#xD;
             of surgery or trauma has been eliminated for less than 14 days.&#xD;
&#xD;
          -  Patients with active or unable to control serious infections;&#xD;
&#xD;
          -  Patients with Grade II or higher myocardial ischemia, myocardial infarction or&#xD;
             malignant arrhythmias(including QTc male ≥ 450 ms, female ≥ 470 ms) ; Patients with&#xD;
             grade III to IV cardiac insufficiency, or left ventricular ejection fraction (LVEF)&#xD;
             &lt;50% (NYHA Classification)&#xD;
&#xD;
          -  Patients with non-healing wounds or fractures&#xD;
&#xD;
          -  with kinds of factors which affect oral medicine (e.g. failing to swallow,&#xD;
             gastrointestinal tract getting resected, chronic diarrhea and ileus).&#xD;
&#xD;
          -  get arterial/venous thrombosis within 12 months, such as cerebrovascular accidents&#xD;
             (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism&#xD;
&#xD;
          -  plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the&#xD;
             medicine-taking period of this research, including Cytotoxic Therapy, Signal&#xD;
             Transduction Inhibitor, and Immunotherapy&#xD;
&#xD;
          -  Patients with cirrhosis, decompensated liver disease, or active hepatitis Have&#xD;
             suffered from hemorrhagic disease or coagulation dysfunction&#xD;
&#xD;
          -  diagnosed with disease which will severely endanger the security of patients or&#xD;
             influence the completion of this research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>enxiao li, professor</last_name>
    <role>Study Chair</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>enxiao li, professor</last_name>
    <phone>0086-13992819833</phone>
    <email>doclienxiao@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>jingjing miao</last_name>
    <phone>0086-18392055301</phone>
    <email>miaojing0403@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shaanxi Provincial Cancer Hospital</name>
      <address>
        <city>Xian</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>minhui wu, doctor</last_name>
      <phone>13891825509</phone>
      <email>wuminhui@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>April 1, 2020</last_update_submitted>
  <last_update_submitted_qc>April 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-squamous NSCLC</keyword>
  <keyword>Anlotinib</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>
  <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/NCT03755869
org study id: XJTU1AF2018LSK-073
nct id: NCT03755869
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and
      development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and
      tumor celltebiz related kinase -c-Kit kinase. In the phase III study, Patients who failed at
      least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were
      treated with anlotinib (12mg, po. qd. on day 1to14 of a 21-day cycle) or placebo, the
      anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS
      were 1.4 months and 6.3 months.
It is an open, single-arm, multi-center clinical trial conducted in China, and plan to
      Recruiting103 patients who were progressed after first line systemic therapy and
      refused/can't tolerate chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to
      14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1
time frame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
description: Progress free survival (PFS)
measure: Duration of Overall Survival (OS) as Assessed by the Investigator Using RECIST v1.1
time frame: Baseline until death from any cause (up to approximately 24 months)
description: Overall Survival (OS)
measure: Disease Control Rate (DCR)as Assessed by the Investigator Using RECIST v1.1
time frame: First occurrence of PR or CR until PD or death, whichever occurs first (up to 24 months)
description: Disease Control Rate (DCR)
measure: Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1
time frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to 24 months)
description: Objective Response Rate (ORR)
measure: Percentage of Participants with Adverse Events
time frame: Baseline until up to 21 days after end of treatment
description: Percentage of Participants with Adverse Events
arm group label: Anlotinib
arm group type: Experimental
description: Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
intervention type: Drug
intervention name: Anlotinib
description: Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
arm group label: Anlotinib
other name: AL3818
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: enxiao li, professor
role: Study Chair
affiliation: First Affiliated Hospital Xi'an Jiaotong University
last name: enxiao li, professor
phone: 0086-13992819833
email: doclienxiao@sina.com
last name: jingjing miao
phone: 0086-18392055301
email: miaojing0403@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No