<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/NCT03841136</url>
  </required_header>
  <id_info>
    <org_study_id>ALTN-SCLC-001</org_study_id>
    <nct_id>NCT03841136</nct_id>
  </id_info>
  <brief_title>Anlotinib Combined With Etoposide and Platinum in the Treatment of Lung Cancer</brief_title>
  <official_title>Phase II Clinical Trial of Anlotinib Combined With Etoposide and Platinum in the Treatment of Extensive Stage Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan 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>
      To evaluate the progression free survival of patients with extensive stage small cell lung&#xD;
      cancer treated with anlotinib combined with EP/CE regimen&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the progression free survival of patients with extensive stage small cell lung&#xD;
      cancer treated with anlotinib combined with EP/CE regimen To evaluate the safety,&#xD;
      tolerability, overall survival (OS), objective response rate (ORR), disease control rate&#xD;
      (DCR), and quality of life (QoL) of patients with extensive stage small cell lung cancer&#xD;
      treated with anlotinib&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>Phase 2</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>from the first cycle of treatment (day one) to two month after the last cycle</time_frame>
    <description>the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Extensive-stage Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>anlotinib combined with EP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>anlotinib combined with etoposide and platinum</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>anlotinib</intervention_name>
    <description>anlotinib 12mg PO QD CBP(AUC 5mg/mL/min，or DDP（75mg/m2）D1 etoposide（100mg/m2）D1~D3</description>
    <arm_group_label>anlotinib combined with EP</arm_group_label>
    <other_name>etoposide and platinum</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients volunteered to participate in the study and have signed the informed consent.&#xD;
&#xD;
          2. Histological or cytological diagnosis of extensive small cell lung cancer, and no&#xD;
             indication of radical surgery or radiotherapy.&#xD;
&#xD;
          3. There are measurable lesions defined by RECIST standard v1.1. A lesion can be&#xD;
             considered measurable only if the previously irradiated lesion has clear progression&#xD;
             after radiotherapy and the previous irradiated lesion is not the sole lesion.&#xD;
&#xD;
          4. Initially treated patients who have not received any systematic therapy before. If&#xD;
             have received postoperative adjuvant chemotherapy, the time to relapse is at least 6&#xD;
             months from the last adjuvant chemotherapy.&#xD;
&#xD;
        5）18~75 years old; ECOG PS score: 0~1 points; expected survival time is more than 3 months.&#xD;
&#xD;
        6）The main organs's function meets the following criteria within 14 days before treatment:&#xD;
&#xD;
          1. Routine blood test (without blood transfusion within 14 days): a) Hemoglobin (HB) ≥ 90&#xD;
             g / L; b) Absolute neutrophil (ANC) ≥ 1.5 × 109 / L; c) Platelets (PLT) ≥ 80×109/L&#xD;
&#xD;
          2. Biochemical examination: a) Total bilirubin (TBIL) ≤ 1.5 times of the upper limit of&#xD;
             the normal (ULN); b) Alanine aminotransferase (ALT) and aspartate aminotransferase AST&#xD;
             ≤ 2.5ULN.To patients with liver metastasis, ALT and AST ≤ 5ULN; c) Serum creatinine&#xD;
             (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min;&#xD;
&#xD;
          3. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ the lower&#xD;
             limit of the normal (50%).&#xD;
&#xD;
        7）Patients with previously treated asymptomatic CNS metastases are allowed to participate&#xD;
        in this study if all of the following criteria are met: a) No need for continuous&#xD;
        corticosteroid therapy for CNS disease; b) No radiotherapy within 7 days prior to&#xD;
        enrollment treatment; c) Imaging examination from the end of radiotherapy to screening&#xD;
        period shows no CNS progression.&#xD;
&#xD;
        8）Women of childbearing age should agree to conduct contraception (such as intrauterine&#xD;
        devices, contraceptives or condoms) during the study and within 6 months after the end of&#xD;
        the study; and the serum or urine pregnancy test is negative within 7 days prior to study&#xD;
        enrollment and they must be non-lactating patients; Men should agree to conduct&#xD;
        contraception during the study and within 6 months after the end of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have been treated with anlotinib capsules in the past.&#xD;
&#xD;
          2. Patients who have previously received systemic chemotherapy, signal transduction&#xD;
             inhibitors, targeted therapies, hormone and endocrine therapy.&#xD;
&#xD;
          3. Patients with other malignant tumors occurred within 5 years prior to the enrollment,&#xD;
             except those with cured cervical carcinoma in situ and superficial bladder tumors [Ta&#xD;
             (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement&#xD;
             membrane)] , basal or squamous cell skin cancer, and localized prostate cancer and&#xD;
             ductal breast carcinoma in situ treated with radical surgery.&#xD;
&#xD;
          4. Unresolved toxicity due to any previous treatment above CTC AE (4.0) level 2 or&#xD;
             higher, excluding hair loss.&#xD;
&#xD;
          5. Patients with a variety of factors affecting oral medications (such as dyspahgia,&#xD;
             gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)&#xD;
&#xD;
          6. Patients with symptomatic CNS metastases.&#xD;
&#xD;
          7. Patients with dysfucitonal coagulation (PT&gt;16s, APTT&gt;43s, TT&gt;21s, Fbg&lt;2g/L), and&#xD;
             bleeding tendency (the following condition must be met within 14 days before the&#xD;
             enrollment: the INR is within the normal range without using anticoagulants); Patients&#xD;
             treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or the&#xD;
             like; Patients with International Normalized Ratio (INR) of less than1.5 are allowed&#xD;
             to use low-dose warfarin (1 mg orally, once daily) or aspirin (with a daily dose of no&#xD;
             more than 100 mg) for prophylactic purposes.&#xD;
&#xD;
          8. Patients with major surgical treatment, incisional biopsy or tremendous traumatic&#xD;
             injury within 28 days prior to the enrollment.&#xD;
&#xD;
          9. Patients with tumors that have invaded tissues surrounding vital blood vessels founded&#xD;
             in imaging or with a high probability of fatal bleeding due to the invasion of tumors&#xD;
             to vital blood vessels according to the judgements of the researchers during the&#xD;
             follow-up study.&#xD;
&#xD;
         10. Patients with uncontrolled pleural, pericardial, or peritoneal effusion requiring&#xD;
             repeated drainage.&#xD;
&#xD;
         11. Patients with any severe and/or uncontrolled disease, including:&#xD;
&#xD;
               1. Patients with unsatisfactory blood pressure control (systolic blood pressure &gt;150&#xD;
                  mmHg, diastolic blood pressure &gt;90 mmHg).&#xD;
&#xD;
               2. Patients with myocardial ischemia or myocardial infarction of Grade I of higher&#xD;
                  level, arrhythmia (including QTC ≥ 440ms) and congestive heart failure above&#xD;
                  Grade 2 (New York Heart Association (NYHA) classification).&#xD;
&#xD;
               3. Patients with active or uncontrolled severe infection (≥ CTC AE Level 2).&#xD;
&#xD;
               4. Patients with a history of immunodeficiency, including HIV-positive or other&#xD;
                  acquired, congenital immunodeficiency disease, or a history of organ&#xD;
                  transplantation.&#xD;
&#xD;
               5. Patients with poor control of diabetes (fasting blood glucose (FBG)&gt;10mmol/L).&#xD;
&#xD;
               6. Patients with urine protein ≥ ++ indicated by routine urine test, and confirmed&#xD;
                  24-hour urine protein quantitation &gt; 1.0 g.&#xD;
&#xD;
               7. Patients with seizures requiring treatment.&#xD;
&#xD;
         12. Patients with bleeding tendency or medical history regardless of severity; Patients&#xD;
             undergone bleeding events of a level ≥ CTCAE 3 within 4 weeks prior to the enrollment,&#xD;
             and with unhealed wounds, ulcers or fractures.&#xD;
&#xD;
         13. Patients undergone venous thrombosis events currently or within 6 months, such as&#xD;
             cerebrovascular accidents (including transient ischemic attacks), deep vein&#xD;
             thrombosis, and pulmonary embolism.&#xD;
&#xD;
         14. Patients with a history of psychotropic drug abuse from which they are unable to&#xD;
             abstain or with mental disorders.&#xD;
&#xD;
         15. Patients who have participated in other clinical trials of anti-tumor drugs within&#xD;
             four weeks.&#xD;
&#xD;
         16. Patients with severe disease that threaten the safety of themselves or affect the&#xD;
             completion of the study according to the investigators' judgment.&#xD;
&#xD;
             -&#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>wang jia lei, doctor</last_name>
    <phone>18017312369</phone>
    <email>haitunqiao@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>wang jia lei, PD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Jialei Wang</investigator_full_name>
    <investigator_title>Attending</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etoposide</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/NCT03841136
org study id: ALTN-SCLC-001
nct id: NCT03841136
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the progression free survival of patients with extensive stage small cell lung
      cancer treated with anlotinib combined with EP/CE regimen
To evaluate the progression free survival of patients with extensive stage small cell lung
      cancer treated with anlotinib combined with EP/CE regimen To evaluate the safety,
      tolerability, overall survival (OS), objective response rate (ORR), disease control rate
      (DCR), and quality of life (QoL) of patients with extensive stage small cell lung cancer
      treated with anlotinib
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PFS
time frame: from the first cycle of treatment (day one) to two month after the last cycle
description: the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen
arm group label: anlotinib combined with EP
arm group type: Experimental
description: anlotinib combined with etoposide and platinum
intervention type: Drug
intervention name: anlotinib
description: anlotinib 12mg PO QD CBP(AUC 5mg/mL/min，or DDP（75mg/m2）D1 etoposide（100mg/m2）D1~D3
arm group label: anlotinib combined with EP
other name: etoposide and platinum
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: wang jia lei, doctor
phone: 18017312369
email: haitunqiao@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Jialei Wang
investigator title: Attending
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Etoposide