<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/NCT03037086</url>
  </required_header>
  <id_info>
    <org_study_id>D4191R00002</org_study_id>
    <nct_id>NCT03037086</nct_id>
  </id_info>
  <brief_title>Asia PDL1 Study Among NSCLC Patients</brief_title>
  <acronym>MEDI-APEX</acronym>
  <official_title>A Retrospective Non-Interventional Study of PD-L1 Prevalence and Clinical Outcomes for Non-Small Cell Lung Cancer in Asia-Pacific</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1&#xD;
      expression and to assess the clinical characteristics and outcomes among NSCLC patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1&#xD;
      expression among NSCLC patients and to assess the clinical characteristics and outcomes of&#xD;
      these patients with specific attention to EGFR, ALK, and KRAS mutations. The study will&#xD;
      determine whether PD-L1 is a prognostic factor in the Asia-Pacific patient population; The&#xD;
      study will enrol NSCLC patients with disease diagnosis between January 2010 and December&#xD;
      2014; The patients will be recruited from Asia-Pacific, potentially China, Japan, and South&#xD;
      Korea. A total of approximately 750 patients will be enrolled in the study; around 250 NSCLC&#xD;
      patients will be enrolled per country.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2015</start_date>
  <completion_date type="Actual">February 27, 2017</completion_date>
  <primary_completion_date type="Actual">February 27, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Characterization of PD-L1 expression among NSCLC patients</measure>
    <time_frame>from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction</time_frame>
    <description>Characterization of PD-L1 expression among locally advanced, unresectable NSCLC patients (Stage III) and newly diagnosed Stage IV or recurrent metastatic NSCLC patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Examination of overall survival by PD-L1 status among NSCLC patients</measure>
    <time_frame>from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Examination of disease-free survival (DFS) by PD-L1 status among NSCLC patients</measure>
    <time_frame>from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Examination of relapse-free survival (RFS) by PD-L1 status among NSCLC patients</measure>
    <time_frame>from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Examination of progression-free survival (PFS) by PD-L1 status among NSCLC patients</measure>
    <time_frame>from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of patient characteristics by PD-L1 status among NSCLC patients.</measure>
    <time_frame>from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the overlap between PD-L1 expression and presence of EGFR, ALK or KRAS mutations among NSCLC patients</measure>
    <time_frame>from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction</time_frame>
    <description>And the prevalence of PD-L1 expression ≥25%, and ≥90%, will be calculated for each mutation status for the EGFR, ALK and KRAS biomarkers.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">658</enrollment>
  <condition>Locally Advanced or Metastatic NSCLC</condition>
  <arm_group>
    <arm_group_label>One single cohort</arm_group_label>
    <description>One single cohort of NSCLC patients with disease diagnosis between January 2010 and December 2014. The locally advanced or metastatic NSCLC patients should have initiated 1st line palliative chemotherapy by end of 2014.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumour tissue samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include patients with NSCLC, including SqCLC, diagnosed between&#xD;
        01 January 2010 and 31 December 2014&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult male or female (according to age of majority as defined in local regulations).&#xD;
&#xD;
          2. NSCLC diagnosis between 01 January 2010 and 31 December 2014.&#xD;
&#xD;
          3. FFPET collected via core needle biopsy or resection and available in sufficient amount&#xD;
             to complete PD-L1 testing.&#xD;
&#xD;
          4. FFPET tissue samples collected for NSCLC original diagnosis determination or for&#xD;
             further analysis (e.g. research or treatment purposes) until the index date.&#xD;
&#xD;
          5. Patients with locally advanced or metastatic NSCLC who have initiated 1st line&#xD;
             palliative chemotherapy by 31 December 2014.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patients with locally advanced NSCLC with resectable disease and treated with curative&#xD;
        intent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang-We Kim, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hiroyuki Suzuki, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fukushima Medical University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Noriyuki Ebi, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aso Co.,Ltd Iizuka Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Li Zhang, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ping Yu, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sichuan Province Cancer Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iizuka-shi</city>
        <state>Fukuoka-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukushima-shi</city>
        <state>Fukushima-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=3870&amp;filename=D4191R00002_Synopsis_Redacted.pdf</url>
    <description>CSR Synopsis</description>
  </link>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 5, 2016</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>February 27, 2018</last_update_submitted>
  <last_update_submitted_qc>February 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NSCLC</keyword>
  <!-- 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/NCT03037086
org study id: D4191R00002
nct id: NCT03037086
lead sponsor: 
has dmc: No
MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1
      expression and to assess the clinical characteristics and outcomes among NSCLC patients
MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1
      expression among NSCLC patients and to assess the clinical characteristics and outcomes of
      these patients with specific attention to EGFR, ALK, and KRAS mutations. The study will
      determine whether PD-L1 is a prognostic factor in the Asia-Pacific patient population; The
      study will enrol NSCLC patients with disease diagnosis between January 2010 and December
      2014; The patients will be recruited from Asia-Pacific, potentially China, Japan, and South
      Korea. A total of approximately 750 patients will be enrolled in the study; around 250 NSCLC
      patients will be enrolled per country.
observational model: Cohort
time perspective: Retrospective
measure: Characterization of PD-L1 expression among NSCLC patients
time frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
description: Characterization of PD-L1 expression among locally advanced, unresectable NSCLC patients (Stage III) and newly diagnosed Stage IV or recurrent metastatic NSCLC patients.
measure: Examination of overall survival by PD-L1 status among NSCLC patients
time frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
measure: Examination of disease-free survival (DFS) by PD-L1 status among NSCLC patients
time frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
measure: Examination of relapse-free survival (RFS) by PD-L1 status among NSCLC patients
time frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
measure: Examination of progression-free survival (PFS) by PD-L1 status among NSCLC patients
time frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
measure: Description of patient characteristics by PD-L1 status among NSCLC patients.
time frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
measure: Description of the overlap between PD-L1 expression and presence of EGFR, ALK or KRAS mutations among NSCLC patients
time frame: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
description: And the prevalence of PD-L1 expression ≥25%, and ≥90%, will be calculated for each mutation status for the EGFR, ALK and KRAS biomarkers.
arm group label: One single cohort
description: One single cohort of NSCLC patients with disease diagnosis between January 2010 and December 2014. The locally advanced or metastatic NSCLC patients should have initiated 1st line palliative chemotherapy by end of 2014.
Tumour tissue samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sang-We Kim, Prof.
role: Principal Investigator
affiliation: Asan Medical Center
last name: Hiroyuki Suzuki, Dr.
role: Principal Investigator
affiliation: Fukushima Medical University Hospital
last name: Noriyuki Ebi, Dr.
role: Principal Investigator
affiliation: Aso Co.,Ltd Iizuka Hospital
last name: Li Zhang, Prof.
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Ping Yu, Prof.
role: Principal Investigator
affiliation: Sichuan Province Cancer Hospital
facility: 
facility: 
facility: 
facility: 
country: China
country: Japan
country: Korea, Republic of
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3870&filename=D4191R00002_Synopsis_Redacted.pdf
description: CSR Synopsis
responsible party type: Sponsor