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/NCT05991180</url>
    </required_header>
    <id_info>
      <org_study_id>BELIEVE RWS</org_study_id>
      <nct_id>NCT05991180</nct_id>
    </id_info>
    <brief_title>Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer</brief_title>
    <official_title>Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer and Assessment of Biomarkers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hunan Province Tumor Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hunan Province Tumor 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>
        This is a descriptive observational study, in which data are collected in an epidemiological&#xD;
        fashion and prospective. This study does not intend to intervene the current medical practice&#xD;
        of the recruited patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>ORR</measure>
      <time_frame>2 years</time_frame>
      <description>Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PFS</measure>
      <time_frame>2 years</time_frame>
      <description>Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>2 years</time_frame>
      <description>Defined as the time from the start of treatment to the death of the subject due to any cause.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Extensive-stage Small-cell Lung Cancer</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        needle biopsy for samples with DNA&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Extensive Stage Small Cell Lung Cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients must be ≥18 years.&#xD;
  &#xD;
            -  Provision of fully informed consent prior to any study specific procedures.&#xD;
  &#xD;
            -  Patients with extensive stage SCLC diagnosed by pathology (as staged by the American&#xD;
               Veterans Lung Cancer Association (VALG)), who do not have an imaging response during&#xD;
               first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions&#xD;
               on first-line therapy (the most recent regimen prior to enrollment must contain&#xD;
               PD-(L)1 inhibitors).&#xD;
  &#xD;
            -  According to the RECIST 1.1 standard, the patient must have at least one measurable&#xD;
               lesion.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Yongchang Zhang, MD</last_name>
      <phone>+8613873123436</phone>
      <email>zhangyongchang@csu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nong Yang, MD</last_name>
      <phone>+8613873123436</phone>
      <email>yangnong0217@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hunan Cancer hospital</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hunan Province Tumor Hospital</investigator_affiliation>
      <investigator_full_name>Yongchang Zhang</investigator_full_name>
      <investigator_title>Professor, Deputy Director of Thoracic Oncology Department</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>
  
  
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/NCT05991180
  org study id: BELIEVE RWS
  nct id: NCT05991180
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a descriptive observational study, in which data are collected in an epidemiological
        fashion and prospective. This study does not intend to intervene the current medical practice
        of the recruited patients.
  observational model: Cohort
  time perspective: Prospective
  measure: ORR
  time frame: 2 years
  description: Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
  measure: PFS
  time frame: 2 years
  description: Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
  measure: OS
  time frame: 2 years
  description: Defined as the time from the start of treatment to the death of the subject due to any cause.
  needle biopsy for samples with DNA
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Yongchang Zhang, MD
  phone: +8613873123436
  email: zhangyongchang@csu.edu.cn
  last name: Nong Yang, MD
  phone: +8613873123436
  email: yangnong0217@163.com
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Hunan Province Tumor Hospital
  investigator full name: Yongchang Zhang
  investigator title: Professor, Deputy Director of Thoracic Oncology Department
  mesh term: Lung Neoplasms
  mesh term: Small Cell Lung Carcinoma