xml: <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/NCT06039683</url>
    </required_header>
    <id_info>
      <org_study_id>D5161R00045</org_study_id>
      <nct_id>NCT06039683</nct_id>
    </id_info>
    <brief_title>A Multicountry, Multicentre, Non-interventional, Retrospective Study to Determine Real-world Treatment Patterns and Associated Outcomes After First Line Osimertinib in Patients With Advanced and Metastatic NSCLC EGFRm in the GCC Region</brief_title>
    <acronym>TREASURE</acronym>
    <official_title>A Multicountry, Multicentre, Non-interventional, Retrospective Study to Determine Real-world Treatment Patterns and Associated Outcomes After First Line Osimertinib in Patients With Advanced and Metastatic NSCLC EGFRm in the GCC Region</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AstraZeneca</source>
    <brief_summary>
      <textblock>
        A Multicountry, Multicenter, Non-interventional, Retrospective Study to determine Real-world&#xD;
        treatment patterns and associated outcomes after FIRST LINE Osimertinib in patients with&#xD;
        advanced and Metastatic NSCLC harboring EGFR-activating mutations in the GCC Region&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Osimertinib has demonstrated superior PFS compared to firstgeneration EGFR-TKIs (erlotinib&#xD;
        and gefitinib) in the first line setting in clinical trials. There remains a need to consider&#xD;
        clinical outcomes in the real-world setting and determine the characteristics of long-term&#xD;
        survivors in the real world. It will also be important to determine the subsequent treatment&#xD;
        pathways of patients who progress on treatment with Osimertinib&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 31, 2022</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>To describe treatments and sequencing after treatment with first line Osimertinib.</measure>
      <time_frame>1st April 2018 till December 31st, 2021.</time_frame>
      <description>Treatments and sequencing after treatment with first line Osimertinib - data on all subsequent lines of treatment, duration and dose changes will be collected until death or last contact or interim data cut-off/end of study period along with disease progression and outcome on the respective line of treatment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To describe real world time to the next treatment or death (rwTTNTD).</measure>
      <time_frame>1st April 2018 till December 31st, 2021.</time_frame>
      <description>rwTTNTD, defined as the time in days from and inclusive of the index date until the start date of the next systemic therapy line or death from any cause (in absence of next systemic therapy line). Patients who do not receive a subsequent systemic therapy line or die during the study observation period will have TTNTD right censored at the earliest date of last contact or interim data cut-off date/end of the study period.</description>
    </primary_outcome>
    <enrollment type="Anticipated">266</enrollment>
    <condition>Carcinoma, Non-Small-Cell Lung</condition>
    <eligibility>
      <study_pop>
        <textblock>
          1. 18 years or older patients had pathological/molecular confirmed advanced/metastatic&#xD;
               EGFRm NSCLC (including both sensitized and uncommon mutations), with or without&#xD;
               previous adjuvant/neoadjuvant chemotherapy, initiating first-line Osimertinib&#xD;
               treatment between 1st April 2018 till December 31st, 2021.&#xD;
  &#xD;
            2. Patients who are treated with short doses of chemotherapy or any other targeted&#xD;
               therapy for up to 28 days before Osimertinib initiation will still be considered&#xD;
               &quot;firstline Osimertinib patients.&quot;&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          For inclusion in the study, all the following inclusion criteria must be fulfilled:&#xD;
  &#xD;
            1. Patients with Stage IIIB-IV NSCLC using either AJCC 7th or 8th edition with EGFR&#xD;
               mutation.&#xD;
  &#xD;
            2. Age 18 or older at index date (specific age may vary according to country-specific&#xD;
               guidelines)&#xD;
  &#xD;
            3. Treated in the first line with Osimertinib from (April 1st, 2018, until December 31st,&#xD;
               2021).&#xD;
  &#xD;
            4. Medical records available at the participating site reflect at least 9 months of&#xD;
               follow-up from the index date (unless the patient died within the first 9 months of&#xD;
               diagnosis).&#xD;
  &#xD;
          Note: specific databases may have additional inclusion criteria which will be detailed in&#xD;
          country-specific protocol adaptations and statistical analysis plans (SAPs).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Subjects are not eligible for this study if they fulfil any of the following exclusion&#xD;
          criteria:&#xD;
  &#xD;
            1. Failure to meet one or more of the inclusion criteria.&#xD;
  &#xD;
            2. Patients who received curative CRT within 3 months and/or any first-line systemic&#xD;
               anti-cancer therapies (SACT) for advanced/metastatic NSCLC for &gt;28 days prior to&#xD;
               Osimertinib start.&#xD;
  &#xD;
            3. Patients who have prior exposure of I/O therapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>AstraZeneca Clinical Study Information Center</last_name>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kuwait Cancer Control Center</name>
        <address>
          <city>Kuwait</city>
          <zip>42262</zip>
          <country>Kuwait</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Kuwait</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</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>Carcinoma, Non-Small-Cell Lung</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039683
  org study id: D5161R00045
  nct id: NCT06039683
  lead sponsor: 
  A Multicountry, Multicenter, Non-interventional, Retrospective Study to determine Real-world
        treatment patterns and associated outcomes after FIRST LINE Osimertinib in patients with
        advanced and Metastatic NSCLC harboring EGFR-activating mutations in the GCC Region
  Osimertinib has demonstrated superior PFS compared to firstgeneration EGFR-TKIs (erlotinib
        and gefitinib) in the first line setting in clinical trials. There remains a need to consider
        clinical outcomes in the real-world setting and determine the characteristics of long-term
        survivors in the real world. It will also be important to determine the subsequent treatment
        pathways of patients who progress on treatment with Osimertinib
  observational model: Cohort
  time perspective: Retrospective
  measure: To describe treatments and sequencing after treatment with first line Osimertinib.
  time frame: 1st April 2018 till December 31st, 2021.
  description: Treatments and sequencing after treatment with first line Osimertinib - data on all subsequent lines of treatment, duration and dose changes will be collected until death or last contact or interim data cut-off/end of study period along with disease progression and outcome on the respective line of treatment
  measure: To describe real world time to the next treatment or death (rwTTNTD).
  time frame: 1st April 2018 till December 31st, 2021.
  description: rwTTNTD, defined as the time in days from and inclusive of the index date until the start date of the next systemic therapy line or death from any cause (in absence of next systemic therapy line). Patients who do not receive a subsequent systemic therapy line or die during the study observation period will have TTNTD right censored at the earliest date of last contact or interim data cut-off date/end of the study period.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: AstraZeneca Clinical Study Information Center
  phone: 1-877-240-9479
  email: information.center@astrazeneca.com
  facility: 
  status: Recruiting
  country: Kuwait
  responsible party type: Sponsor
  mesh term: Carcinoma, Non-Small-Cell Lung