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/NCT06021483</url>
    </required_header>
    <id_info>
      <org_study_id>BR-LTD-OS-401</org_study_id>
      <nct_id>NCT06021483</nct_id>
    </id_info>
    <brief_title>Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection</brief_title>
    <official_title>Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection (Lurbinectedin) in Patients With Metastatic Small Cell Lung Cancer (SCLC) in Real-World Practice</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boryung Pharmaceutical Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boryung Pharmaceutical Co., Ltd</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <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 evaluate the safety and efficacy of Zepzelca™ inj. in&#xD;
        real-world practice and to investigate important identified risks and gaps in information&#xD;
        related to risk management plans.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 16, 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>ORR (Overall Response Rate)</measure>
      <time_frame>6 months after the start of administration</time_frame>
      <description>Percentage of subjects who reached complete remission (CR) and partial remission (PR)</description>
    </primary_outcome>
    <other_outcome>
      <measure>SAE &amp; SADR Incidence Rate</measure>
      <time_frame>6 months after the start of administration</time_frame>
      <description>Serious Adverse Event &amp; Serious Adverse Drug Reaction Incidence Rate</description>
    </other_outcome>
    <enrollment type="Anticipated">300</enrollment>
    <condition>SCLC</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients With Metastatic SCLC who have failed first-line platinum-based chemotherapy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who voluntarily provide written consent for personal information collection&#xD;
               and utilization after receiving an explanation about the objective and methods of the&#xD;
               study&#xD;
  &#xD;
            -  Patients who have received or are scheduled to receive Zepzelca™ inj., according to&#xD;
               domestic approval indications&#xD;
  &#xD;
            -  Patients with metastatic SCLC who have failed first-line platinum-based chemotherapy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with no prior history of platinum-based anticancer chemotherapy for cancer&#xD;
               treatment&#xD;
  &#xD;
            -  Patients with a history of hypersensitivity reactions to this drug or its components&#xD;
  &#xD;
            -  Pregnant, potentially pregnant, or lactating women&#xD;
  &#xD;
            -  Patients currently participating in another clinical trial (drug or medical device) or&#xD;
               planning to participate in another clinical trial during the study period (except for&#xD;
               non-interventional clinical studies or cases where the clinical trial drug&#xD;
               administration has ended and only follow-up is remaining)&#xD;
  &#xD;
            -  Patients who are judged by the principle Investigator or sub-Investigator to be&#xD;
               ineligible to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Shinyoung Oh</last_name>
      <phone>+82-2-708-8000</phone>
      <email>syoh@boryung.co.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Boramae Medical Center</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ki-Hwan Kim, M.D., Ph.D.</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06021483
  org study id: BR-LTD-OS-401
  nct id: NCT06021483
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the safety and efficacy of Zepzelca™ inj. in
        real-world practice and to investigate important identified risks and gaps in information
        related to risk management plans.
  observational model: Cohort
  time perspective: Prospective
  measure: ORR (Overall Response Rate)
  time frame: 6 months after the start of administration
  description: Percentage of subjects who reached complete remission (CR) and partial remission (PR)
  measure: SAE & SADR Incidence Rate
  time frame: 6 months after the start of administration
  description: Serious Adverse Event & Serious Adverse Drug Reaction Incidence Rate
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shinyoung Oh
  phone: +82-2-708-8000
  email: syoh@boryung.co.kr
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor