<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/NCT03778853</url>
  </required_header>
  <id_info>
    <org_study_id>20180049</org_study_id>
    <nct_id>NCT03778853</nct_id>
  </id_info>
  <brief_title>Study of Anlotinib in Advanced Non-squamous NSCLC Patients in the Elderly Without Systemic Chemotherapy (ALTER-L006)</brief_title>
  <official_title>An Open, Single-arm, Multi-center Study of Anlotinib in Advanced Non-squamous NSCLC Patients in the Elderly Without Systemic Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LanZhou University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>General Hospital of Ningxia Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>LanZhou University</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>
      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;
      Recruiting 72 patients in the elderly without systemic chemotherapy. Patents receive 12mg&#xD;
      anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess&#xD;
      safety and efficacy of the drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>PFS</measure>
    <time_frame>Time Frame: each 42 days up to PD or death(up to 24 months)</time_frame>
    <description>Progress free survival (PFS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>From randomization until death (up to 24 months)</time_frame>
    <description>Overall Survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>each 42 days up to intolerance the toxicity or PD (up to 24 months)</time_frame>
    <description>Disease Control Rate (DCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>each 42 days up to intolerance the toxicity or PD (up to 24 months)</time_frame>
    <description>Objective Response Rate (ORR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Until 30 day safety follow-up visit</time_frame>
    <description>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-C30</measure>
    <time_frame>each 42 days up to intolerance the toxicity or PD (up to 24 months)</time_frame>
    <description>use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Advanced Non-squamous NSCLC</condition>
  <arm_group>
    <arm_group_label>Anlotinib Hydrochloride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anlotinib Hydrochloride 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 Hydrochloride</intervention_name>
    <description>Anlotinib Hydrochloride ( 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.&#xD;
Other Name: AL3818</description>
    <arm_group_label>Anlotinib Hydrochloride</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated informed consent&#xD;
&#xD;
          -  Age：≥70&#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;
        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;
          -  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>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>xiaoming hou, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>LanZhou University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>da zhao, professor</last_name>
    <phone>0086-13369287188</phone>
    <email>Ydfyzhaohon@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>rui chen, doctor</last_name>
    <phone>0086-13919899287</phone>
    <email>chrui-001@163.com</email>
  </overall_contact_backup>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 15, 2018</last_update_submitted>
  <last_update_submitted_qc>December 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>LanZhou University</investigator_affiliation>
    <investigator_full_name>Chen Rui</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Non-squamous NSCLC</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>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/NCT03778853
org study id: 20180049
nct id: NCT03778853
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: 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
      Recruiting 72 patients in the elderly without systemic 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: PFS
time frame: Time Frame: each 42 days up to PD or death(up to 24 months)
description: Progress free survival (PFS)
measure: OS
time frame: From randomization until death (up to 24 months)
description: Overall Survival (OS)
measure: DCR
time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
description: Disease Control Rate (DCR)
measure: ORR
time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
description: Objective Response Rate (ORR)
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Until 30 day safety follow-up visit
description: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
measure: EORTC QLQ-C30
time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
description: use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life
arm group label: Anlotinib Hydrochloride
arm group type: Experimental
description: Anlotinib Hydrochloride 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 Hydrochloride
description: Anlotinib Hydrochloride ( 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.
Other Name: AL3818
arm group label: Anlotinib Hydrochloride
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: xiaoming hou, professor
role: Principal Investigator
affiliation: LanZhou University
last name: da zhao, professor
phone: 0086-13369287188
email: Ydfyzhaohon@163.com
last name: rui chen, doctor
phone: 0086-13919899287
email: chrui-001@163.com
responsible party type: Principal Investigator
investigator affiliation: LanZhou University
investigator full name: Chen Rui
investigator title: professor
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Undecided