<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/NCT03823118</url>
  </required_header>
  <id_info>
    <org_study_id>SALTER Trial</org_study_id>
    <nct_id>NCT03823118</nct_id>
  </id_info>
  <brief_title>S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer</brief_title>
  <official_title>S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer：An One-arm, Phase Ⅱ, Multi-center Clinical Study (SALTER TRIAL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taizhou Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taizhou Hospital</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>
      The purpose of this study is to assess the efficacy and safety of S1 combination with&#xD;
      Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence&#xD;
      after at least one standard chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although SCLC is very responsive to initial treatment, most patients relapse with relatively&#xD;
      resistant disease.These patients have a median survival of only 4 to 5 months when treated&#xD;
      with further systemic therapy. Improvements in therapy for relapsed SCLC are much needed.The&#xD;
      purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib&#xD;
      in patients with small cell lung cancer whose cancer has progression or recurrence after at&#xD;
      least one standard chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">April 17, 2021</completion_date>
  <primary_completion_date type="Actual">June 28, 2020</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>Objective Response Rate (ORR)</measure>
    <time_frame>each 21 days up to the toxicity or PD (up to 6 months)</time_frame>
    <description>measured by Response Evaluation Criteria in Solid Tumors version 1.1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>progression-free survival (PFS)</measure>
    <time_frame>Duration of time from the start of treatment to the first documented disease progression according to RECIST 1.1 or death due to any cause, whichever occurs first, assessed up to 12 months</time_frame>
    <description>PFS will be estimated using standard Kaplan Meier survival analysis methods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Duration of time from the start of treatment to date of death, assessed up to 2 years</time_frame>
    <description>OS will be estimated using standard Kaplan Meier survival analysis methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Small Cell Lung Cancer Recurrent</condition>
  <arm_group>
    <arm_group_label>S1/Anlotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S1/Anlotinib</intervention_name>
    <description>Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.</description>
    <arm_group_label>S1/Anlotinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytologically confirmed small cell lung cancer;&#xD;
&#xD;
          -  Systemic chemotherapy that has previously received at least one or more lines regimen,&#xD;
             followed by disease progression or recurrence;&#xD;
&#xD;
          -  Age 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months&#xD;
&#xD;
          -  participants had at least one measurable target lesion by RECIST1.1&#xD;
&#xD;
          -  The main organ function meets the following criteria:absolute value of neutrophils ≥&#xD;
             1.5 × 109 / L, platelets ≥80 × 109 / L, hemoglobin ≥ 80 g / L;total bilirubin ≤ 1.5&#xD;
             times the upper limit of normal value, aspartate aminotransferase and alanine&#xD;
             aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤&#xD;
             upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of&#xD;
             normal;&#xD;
&#xD;
          -  Patients should participate in the study voluntarily and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have been used anti-angiogenesis inhibitors,such as (such as&#xD;
             sunitinib,bevacizumab,endostar et al.&#xD;
&#xD;
          -  Subjects with symptomatic brain metastases;&#xD;
&#xD;
          -  Patients whose primary lesion with active bleeding within 4 months&#xD;
&#xD;
          -  Hypertension, which is uncontrolled by the drug, is defined as: systolic blood&#xD;
             pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg&#xD;
&#xD;
          -  Patients with active or unable to control serious infections&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Taizhou Hospital, Wenzhou Medical University</name>
      <address>
        <city>Taizhou</city>
        <state>Zhejiang</state>
        <zip>317000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Enze Hospital</name>
      <address>
        <city>Taizhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanmen People's Hospital</name>
      <address>
        <city>Taizhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taizhou Hospital</investigator_affiliation>
    <investigator_full_name>Haihua Yang</investigator_full_name>
    <investigator_title>Head of Department of Radiation Oncology</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>
  <!-- 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/NCT03823118
org study id: SALTER Trial
nct id: NCT03823118
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the efficacy and safety of S1 combination with
      Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence
      after at least one standard chemotherapy.
Although SCLC is very responsive to initial treatment, most patients relapse with relatively
      resistant disease.These patients have a median survival of only 4 to 5 months when treated
      with further systemic therapy. Improvements in therapy for relapsed SCLC are much needed.The
      purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib
      in patients with small cell lung cancer whose cancer has progression or recurrence after at
      least one standard chemotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: each 21 days up to the toxicity or PD (up to 6 months)
description: measured by Response Evaluation Criteria in Solid Tumors version 1.1
measure: progression-free survival (PFS)
time frame: Duration of time from the start of treatment to the first documented disease progression according to RECIST 1.1 or death due to any cause, whichever occurs first, assessed up to 12 months
description: PFS will be estimated using standard Kaplan Meier survival analysis methods.
measure: Overall survival (OS)
time frame: Duration of time from the start of treatment to date of death, assessed up to 2 years
description: OS will be estimated using standard Kaplan Meier survival analysis methods.
measure: Incidence of adverse events
time frame: Up to 2 years
description: Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
arm group label: S1/Anlotinib
arm group type: Experimental
description: Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.
intervention type: Drug
intervention name: S1/Anlotinib
description: Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.
arm group label: S1/Anlotinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Taizhou Hospital
investigator full name: Haihua Yang
investigator title: Head of Department of Radiation Oncology
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma