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/NCT06008353</url>
    </required_header>
    <id_info>
      <org_study_id>LACOG 0322</org_study_id>
      <secondary_id>D4191R00053</secondary_id>
      <nct_id>NCT06008353</nct_id>
    </id_info>
    <brief_title>A Real-World Assessment of the Demographic, Clinical Characteristics and Outcomes of a Brazilian Cohort of Previously Untreated Extensive Stage-Small Cell Lung Cancer Receiving Durvalumab Combined With Platinum-Etoposide in (ES-SCLC) in Brazil</brief_title>
    <acronym>EDUR-BRA</acronym>
    <official_title>A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort of Patients With Extensive Stage Small Cell Lung Cancer Treated With Durvalumab in Combination With Platinum-etoposide.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Latin American Cooperative Oncology Group</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Latin American Cooperative Oncology Group</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 central objective of this study is to assess the efficacy and safety of durvalumab-based&#xD;
        regimens in 1L treatment of ES-SCLC Brazilian patients. By collecting patient's baseline and&#xD;
        medical history data, the study will also provide relevant demographic information about SCLC&#xD;
        patients in the private health setting in Brazil, which has not been extensively explored in&#xD;
        the past.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 20, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2026</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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Demographic Characteristics of the Cohort</measure>
      <time_frame>Baseline.</time_frame>
      <description>This measure encompasses relevant demographic information of the patients included in the cohort, including median age at diagnosis, gender distribution, smoking history, and World Health Organization Performance Status (WHO PS) score. These details will provide a comprehensive understanding of the patient profile within the cohort.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Characteristics of the Cohort</measure>
      <time_frame>Baseline.</time_frame>
      <description>This measure encompasses relevant clinical information of the patients included in the cohort, including presence of hepatic and cerebral metastases, type of platinum used in first-line (1L) treatment, and diagnostic stage (III vs. IV) of CPPC-EE. These details will provide a comprehensive understanding of the patient profile within the cohort.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of Demographic and Clinical Characteristics between Recurrent and Newly Diagnosed CPPC-EE Patients</measure>
      <time_frame>During the cohort follow-up, an average of 24 months, starting from diagnosis.</time_frame>
      <description>This measure focuses on comparing patients with recurrent CPPC-EE and those newly diagnosed. The incidence of disease recurrence and distinct demographic and clinical characteristics between these groups, such as age, gender, smoking history, World Health Organization Performance Status (WHO PS) score, presence of hepatic and cerebral metastases, type of platinum used in first-line (1L) treatment, and diagnostic stage, will be analyzed and reported. This will allow for a deeper understanding of differences between recurrent and newly diagnosed patients.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Extensive-stage Small-cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Adult patients newly diagnosed with ES-SCLC</arm_group_label>
      <description>The study will include consecutive adult patients newly diagnosed with ES-SCLC (patients with the recurrent limited stage disease are also eligible).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational study</intervention_name>
      <description>This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.</description>
      <arm_group_label>Adult patients newly diagnosed with ES-SCLC</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Male or female patients (aged 18 years or older) with histologically- or&#xD;
          cytologically-documented ES-SCLC receiving a durvalumab-based regimen as a first-line&#xD;
          treatment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have a documented diagnosis of ES-SCLC (newly diagnosed patients, as well as limited&#xD;
               stage relapsed patients, are eligible);&#xD;
  &#xD;
            -  Have been treated with a durvalumab-based regimen for 1L ES-SCLC in the past&#xD;
               (retrospective) OR is currently being treated with a durvalumab-based regimen for 1L&#xD;
               ES-SCLC (prospective);&#xD;
  &#xD;
            -  Male or female adult patients ≥ 18 years of age (as per local Durvalumab approved&#xD;
               label);&#xD;
  &#xD;
            -  Provision of consent in a signed informed consent form (ICF) (allowing for data to be&#xD;
               captured from existing medical records). If the patient´s data is entirely&#xD;
               retrospective (i.e., the patient already presented progression, death, or completed 18&#xD;
               months of durvalumab-based treatment), the ICF may be waived, as decided by the local&#xD;
               ethics committee.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Since the study is observational, there are no Exclusion Criteria. If the patient&#xD;
               meets all the Inclusion Criteria, he/she will be eligible for the study.&#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>Mauro Zukin</last_name>
      <role>Principal Investigator</role>
      <affiliation>Latin American Cooperative Oncology Group</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laura Mendonça</last_name>
      <phone>+55 51 3384 5334</phone>
      <email>laura.mendonca@lacogcancerresearch.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Laura Voelcker</last_name>
      <phone>+55 51 3384 5334</phone>
      <email>laura.voelcker@lacogcancerresearch.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 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>Lung Neoplasms</mesh_term>
      <mesh_term>Small Cell Lung Carcinoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06008353
  org study id: LACOG 0322
  secondary id: D4191R00053
  nct id: NCT06008353
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The central objective of this study is to assess the efficacy and safety of durvalumab-based
        regimens in 1L treatment of ES-SCLC Brazilian patients. By collecting patient's baseline and
        medical history data, the study will also provide relevant demographic information about SCLC
        patients in the private health setting in Brazil, which has not been extensively explored in
        the past.
  observational model: Cohort
  time perspective: Other
  measure: Demographic Characteristics of the Cohort
  time frame: Baseline.
  description: This measure encompasses relevant demographic information of the patients included in the cohort, including median age at diagnosis, gender distribution, smoking history, and World Health Organization Performance Status (WHO PS) score. These details will provide a comprehensive understanding of the patient profile within the cohort.
  measure: Clinical Characteristics of the Cohort
  time frame: Baseline.
  description: This measure encompasses relevant clinical information of the patients included in the cohort, including presence of hepatic and cerebral metastases, type of platinum used in first-line (1L) treatment, and diagnostic stage (III vs. IV) of CPPC-EE. These details will provide a comprehensive understanding of the patient profile within the cohort.
  measure: Comparison of Demographic and Clinical Characteristics between Recurrent and Newly Diagnosed CPPC-EE Patients
  time frame: During the cohort follow-up, an average of 24 months, starting from diagnosis.
  description: This measure focuses on comparing patients with recurrent CPPC-EE and those newly diagnosed. The incidence of disease recurrence and distinct demographic and clinical characteristics between these groups, such as age, gender, smoking history, World Health Organization Performance Status (WHO PS) score, presence of hepatic and cerebral metastases, type of platinum used in first-line (1L) treatment, and diagnostic stage, will be analyzed and reported. This will allow for a deeper understanding of differences between recurrent and newly diagnosed patients.
  arm group label: Adult patients newly diagnosed with ES-SCLC
  description: The study will include consecutive adult patients newly diagnosed with ES-SCLC (patients with the recurrent limited stage disease are also eligible).
  intervention type: Other
  intervention name: Observational study
  description: This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
  arm group label: Adult patients newly diagnosed with ES-SCLC
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mauro Zukin
  role: Principal Investigator
  affiliation: Latin American Cooperative Oncology Group
  last name: Laura Mendonça
  phone: +55 51 3384 5334
  email: laura.mendonca@lacogcancerresearch.org
  last name: Laura Voelcker
  phone: +55 51 3384 5334
  email: laura.voelcker@lacogcancerresearch.org
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Small Cell Lung Carcinoma
  sharing ipd: No