<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/NCT04453423</url>
  </required_header>
  <id_info>
    <org_study_id>AN001</org_study_id>
    <nct_id>NCT04453423</nct_id>
  </id_info>
  <brief_title>Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.</brief_title>
  <official_title>A Study of the Effect of Anlotinib, Pemetrexed or the Combination As Maintenance Therapy for Patients With Non-Squamous Non-Small Cell Lung Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</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>
      This study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed&#xD;
      or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not&#xD;
      progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. The primary&#xD;
      endpoint of the study is progression-free survival (PFS); the secondary endpoints are disease&#xD;
      control rate (DCR), objective response rate (ORR) and overall survival (OS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>6 months</time_frame>
    <description>PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>each 42 days up to intolerance the toxicity or PD (up to 12 months)</time_frame>
    <description>Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>each 42 days up to intolerance the toxicity or PD (up to 12 months)</time_frame>
    <description>Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>12 months</time_frame>
    <description>OS is calculated from diagnosis to death or last follow-up time.</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>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Non-squamous Non-small-cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>First-line Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anlotinib + Pemetrexed+Carboplatin</intervention_name>
    <description>Anlotinib: 12mg, QD, PO, d1-14, 21 days per cycle&#xD;
Carboplatin: AUC 5 on day 1 of 21 days per cycle&#xD;
Pemetrexed: 500mg/m2 iv on day 1 of 21 days per cycle</description>
    <arm_group_label>First-line Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <description>500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)</description>
    <arm_group_label>Maintenance Treatment A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anlotinib + Pemetrexed</intervention_name>
    <description>Anlotinib:12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)&#xD;
Pemetrexed:500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)</description>
    <arm_group_label>Maintenance Treatment B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anlotinib</intervention_name>
    <description>12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)</description>
    <arm_group_label>Maintenance Treatment C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3 months;&#xD;
&#xD;
          2. Subjects with histologically or cytologically confirmed locally advanced and/or&#xD;
             advanced Non-squamous NSCLC;&#xD;
&#xD;
          3. Signed and dated informed consent;&#xD;
&#xD;
          4. adequate hematological, liver and renal function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. prior chemotherapy or treatment with another systemic anti-cancer agent&#xD;
&#xD;
          2. malignancies other than NSCLC within 5 years prior to randomization, except for&#xD;
             adequately treated carcinoma in situ of the cervix, basal or squamous cell skin&#xD;
             cancer, localized prostate cancer or DCIS&#xD;
&#xD;
          3. evidence of tumor invading major blood vessels&#xD;
&#xD;
          4. current or recent use of aspirin (&gt;325mg/day) or full-dose anticoagulants or&#xD;
             thrombolytic agents for therapeutic purposes&#xD;
&#xD;
          5. history of haemoptysis &gt;/=grade 2&#xD;
&#xD;
          6. clinically significant cardiovascular disease&#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_contact>
    <last_name>Renhua Guo, MD</last_name>
    <phone>025-68136360</phone>
    <email>rhguo@njmu.edu.cn</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 27, 2020</last_update_submitted>
  <last_update_submitted_qc>June 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</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>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>Carboplatin</mesh_term>
    <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/NCT04453423
org study id: AN001
nct id: NCT04453423
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed
      or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not
      progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. The primary
      endpoint of the study is progression-free survival (PFS); the secondary endpoints are disease
      control rate (DCR), objective response rate (ORR) and overall survival (OS).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival (PFS)
time frame: 6 months
description: PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.
measure: Objective Response Rate (ORR)
time frame: each 42 days up to intolerance the toxicity or PD (up to 12 months)
description: Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR).
measure: Disease control rate (DCR)
time frame: each 42 days up to intolerance the toxicity or PD (up to 12 months)
description: Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).
measure: Overall Survival (OS)
time frame: 12 months
description: OS is calculated from diagnosis to death or last follow-up time.
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
arm group label: First-line Treatment
arm group type: Other
arm group label: Maintenance Treatment A
arm group type: Experimental
arm group label: Maintenance Treatment B
arm group type: Experimental
arm group label: Maintenance Treatment C
arm group type: Experimental
intervention type: Drug
intervention name: Anlotinib + Pemetrexed+Carboplatin
description: Anlotinib: 12mg, QD, PO, d1-14, 21 days per cycle
Carboplatin: AUC 5 on day 1 of 21 days per cycle
Pemetrexed: 500mg/m2 iv on day 1 of 21 days per cycle
arm group label: First-line Treatment
intervention type: Drug
intervention name: Pemetrexed
description: 500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
arm group label: Maintenance Treatment A
intervention type: Drug
intervention name: Anlotinib + Pemetrexed
description: Anlotinib:12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)
Pemetrexed:500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
arm group label: Maintenance Treatment B
intervention type: Drug
intervention name: Anlotinib
description: 12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)
arm group label: Maintenance Treatment C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Renhua Guo, MD
phone: 025-68136360
email: rhguo@njmu.edu.cn
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Carboplatin
mesh term: Pemetrexed