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/NCT05991206</url>
    </required_header>
    <id_info>
      <org_study_id>NATAL RWS</org_study_id>
      <nct_id>NCT05991206</nct_id>
    </id_info>
    <brief_title>A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC</brief_title>
    <official_title>A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB Driver Gene-Negative Non-Small Cell Lung Cancer (NSCLC)</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">August 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 1, 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>MPR Rate</measure>
      <time_frame>2 years</time_frame>
      <description>Neoadjuvant therapy-induced tumor regression in pathologically residual tumors &lt;10%</description>
    </primary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>NSCLC</condition>
    <eligibility>
      <study_pop>
        <textblock>
          stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC&#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;
            -  Previously untreated, histologically confirmed resectable stage II, IIIA, IIIB (N2)&#xD;
               (AJCC stage VIII) NSCLC; cTNM stage can be confirmed by PET-CT or pathological biopsy;&#xD;
               resectable stage II non-small cell lung cancer is defined as radical resection as&#xD;
               assessed by a qualified thoracic surgeon; resectable is resectable and potentially&#xD;
               resectable as defined by the Expert Consensus on Multidisciplinary Diagnosis and&#xD;
               Treatment of Stage III Non-small Cell Lung Cancer (2019 version); resectable includes&#xD;
               IIIA (N0-1), some single-station mediastinal lymph node metastases with N2 and some T4&#xD;
               (satellite nodules present in adjacent lobes) N1; potentially resectable includes some&#xD;
               stage IIIA and IIIB, including single-station N2 mediastinal lymph node short diameter&#xD;
               &lt; 3 cm stage IIIA NSCLC, potentially resectable T3 or T4 central tumors; Solid/solid&#xD;
               pulmonary nodules, not pure ground-glass opacity (GGO), are strongly recommended for&#xD;
               pathological puncture verification.&#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;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#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>
      <phone_ext>7+861383123436</phone_ext>
      <email>zhangyongchang@csu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nong Yang</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>
          <zip>410013</zip>
          <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>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/NCT05991206
  org study id: NATAL RWS
  nct id: NCT05991206
  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: MPR Rate
  time frame: 2 years
  description: Neoadjuvant therapy-induced tumor regression in pathologically residual tumors <10%
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Yongchang Zhang, MD
  phone: +8613873123436
  phone ext: 7+861383123436
  email: zhangyongchang@csu.edu.cn
  last name: Nong Yang
  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: Carcinoma, Non-Small-Cell Lung