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/NCT05974007</url>
    </required_header>
    <id_info>
      <org_study_id>22/093-3294</org_study_id>
      <nct_id>NCT05974007</nct_id>
    </id_info>
    <brief_title>Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC</brief_title>
    <acronym>NeoR-World</acronym>
    <official_title>Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC: A Retrospective Multi-center Study (NeoR-World)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Despite the clinical success of immune checkpoint blockade (ICB), in neoadjuvant setting,&#xD;
        there is still a lack of valid data for operable NSCLC in the real world. This study aim to&#xD;
        compare the clinical outcomes (pathologic response rate versus survival) of neoadjuvant&#xD;
        immunochemotherapy with neoadjuvant chemotherapy in the real world, to explore the impact of&#xD;
        clinicopathological factors on clinical outcomes in neoadjuvant immunochemotherapy setting,&#xD;
        and to identify potential neoadjuvant immunochemotherapy beneficiaries.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Although the application of neoadjuvant immunotherapy in NSCLC has brought a new treatment&#xD;
        option to many patients, most evidence is based on interventional clinical trials, in which&#xD;
        the participants are highly selected and the therapeutic strategies are restricted, resulting&#xD;
        in limited representation. There is still a lack of large-scale multicenter real-world data&#xD;
        to further verify the benefits in long term overall survival, identify the potential&#xD;
        beneficiaries and optimize the therapeutic strategies of neoadjuvant immunochemotherapy.&#xD;
  &#xD;
        To meet the forementioned need, the investigators will perform a multi-center retrospective&#xD;
        cohort to describe the patterns of neoadjuvant immunochemotherapy use in real world, compare&#xD;
        the efficacy of neoadjuvant immunochemotherapy ,and evaluate prognosis of neoadjuvant&#xD;
        immunochemotherapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Anticipated">June 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Disease-free survival(DFS)</measure>
      <time_frame>DFS was defined as the time from surgery to the appearance of metastasis, up to approximately 5 years.</time_frame>
      <description>Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pathological Complete Response (pCR)</measure>
      <time_frame>Within 2 weeks after surgery</time_frame>
      <description>defined as 0% of viable tumor cells in primary tumor and lymph nodes</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>OS (overall survival)</measure>
      <time_frame>From date of surgery until date of death due to any cause, up to approximately 5 years.</time_frame>
      <description>OS is defined as the time from surgery tiem until death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (overall survival) Rate</measure>
      <time_frame>From date of surgery until date of death due to any cause. Assessed at 1 years.</time_frame>
      <description>OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (overall survival) Rate</measure>
      <time_frame>From date of surgery until date of death due to any cause. Assessed at 2 years.</time_frame>
      <description>OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (overall survival) Rate</measure>
      <time_frame>From date of surgery until date of death due to any cause. Assessed at 5 years.</time_frame>
      <description>OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EFS (event-free survival)</measure>
      <time_frame>Up to 5 years after first therapy.</time_frame>
      <description>EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Event Free Survival (event-free survival) Rate</measure>
      <time_frame>From date of first received neoadjuvant therapy to 1 years after neoadjuvant.</time_frame>
      <description>EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Event Free Survival (event-free survival) Rate</measure>
      <time_frame>From date of first received neoadjuvant therapy to 2 years after neoadjuvant.</time_frame>
      <description>EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Event Free Survival (event-free survival) Rate</measure>
      <time_frame>From date of first received neoadjuvant therapy to 5 years after neoadjuvant.</time_frame>
      <description>EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Major Pathological Response (MPR)</measure>
      <time_frame>Within 2 weeks after surgery</time_frame>
      <description>defined as ≤10% of viable tumor cells</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patterns of Relapse</measure>
      <time_frame>Within 5 years after surgery</time_frame>
      <description>Relapse was defined as disease recurrence at any site.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Non-Small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Resectable stage I-III NSCLC</arm_group_label>
      <description>Patients with NSCLC patients receiving neoadjuvant therapy and undergoing surgeries. Resectability after neoadjuvant therapy is judged by the multidisciplinary team of thoracic surgeon, oncologist and radiation oncologist.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Neoadjuvant immunochemotherapy</intervention_name>
      <description>Patients with operable stage I-III NSCLC who have previously undergone platinum drugs and immune checkpoint inhibitors(Anti PD-1) and then undergone radical surgery</description>
      <arm_group_label>Resectable stage I-III NSCLC</arm_group_label>
      <other_name>Neoadjuvant immunotherapy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Neoadjuvant chemotherapy</intervention_name>
      <description>Patients with operable stage I-III NSCLC who have previously undergone platinum-based chemotherapy regimens and then undergone radical surgery</description>
      <arm_group_label>Resectable stage I-III NSCLC</arm_group_label>
      <other_name>Neoadjuvant platinum-based doublet chemotherapy</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Stage I-III NSCLC patients undergo neoadjuvant treatment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Cytological or histological diagnosis of non-small cell lung cancer&#xD;
  &#xD;
            2. Patients who have previously undergone neoadjuvant immune checkpoint inhibitors and/or&#xD;
               chemotherapy and then undergone radical surgery;&#xD;
  &#xD;
            3. Stage I-III non-small cell lung cancer (IASLC/UICC staging eighth edition);&#xD;
  &#xD;
            4. No previous history of malignant tumors and other malignant tumors at the same time,&#xD;
               without any anti-tumor treatment;&#xD;
  &#xD;
            5. ECOG score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;&#xD;
  &#xD;
            6. At least one measurable lesion (RECIST v1.1);&#xD;
  &#xD;
            7. Age &gt;= 18 years old and &lt;= 85 years old;&#xD;
  &#xD;
            8. Be able to abide by the visits and related procedures stipulated in the program.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients included in anti-tumor drug intervention or unblinded clinical trials, in&#xD;
               which the treatment being administered is unknown.&#xD;
  &#xD;
            2. Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency&#xD;
               ablation, etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jie He, Dr.</last_name>
      <role>Study Chair</role>
      <affiliation>Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jie He, Dr.</last_name>
      <phone>010-87788863</phone>
      <email>prof.jiehe@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100021</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jie He, Dr.</last_name>
        <phone>010-87788863</phone>
        <email>prof.jiehe@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>NSCLC</keyword>
    <keyword>Neoadjuvant immunochemotherapy</keyword>
    <keyword>Neoadjuvant chemotherapy</keyword>
    <keyword>Real world study</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Immunomodulating Agents</mesh_term>
    </intervention_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/NCT05974007
  org study id: 22/093-3294
  nct id: NCT05974007
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Despite the clinical success of immune checkpoint blockade (ICB), in neoadjuvant setting,
        there is still a lack of valid data for operable NSCLC in the real world. This study aim to
        compare the clinical outcomes (pathologic response rate versus survival) of neoadjuvant
        immunochemotherapy with neoadjuvant chemotherapy in the real world, to explore the impact of
        clinicopathological factors on clinical outcomes in neoadjuvant immunochemotherapy setting,
        and to identify potential neoadjuvant immunochemotherapy beneficiaries.
  Although the application of neoadjuvant immunotherapy in NSCLC has brought a new treatment
        option to many patients, most evidence is based on interventional clinical trials, in which
        the participants are highly selected and the therapeutic strategies are restricted, resulting
        in limited representation. There is still a lack of large-scale multicenter real-world data
        to further verify the benefits in long term overall survival, identify the potential
        beneficiaries and optimize the therapeutic strategies of neoadjuvant immunochemotherapy.
  
        To meet the forementioned need, the investigators will perform a multi-center retrospective
        cohort to describe the patterns of neoadjuvant immunochemotherapy use in real world, compare
        the efficacy of neoadjuvant immunochemotherapy ,and evaluate prognosis of neoadjuvant
        immunochemotherapy.
  observational model: Cohort
  time perspective: Retrospective
  measure: Disease-free survival(DFS)
  time frame: DFS was defined as the time from surgery to the appearance of metastasis, up to approximately 5 years.
  description: Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
  measure: Pathological Complete Response (pCR)
  time frame: Within 2 weeks after surgery
  description: defined as 0% of viable tumor cells in primary tumor and lymph nodes
  measure: OS (overall survival)
  time frame: From date of surgery until date of death due to any cause, up to approximately 5 years.
  description: OS is defined as the time from surgery tiem until death from any cause.
  measure: Overall Survival (overall survival) Rate
  time frame: From date of surgery until date of death due to any cause. Assessed at 1 years.
  description: OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis.
  measure: Overall Survival (overall survival) Rate
  time frame: From date of surgery until date of death due to any cause. Assessed at 2 years.
  description: OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis.
  measure: Overall Survival (overall survival) Rate
  time frame: From date of surgery until date of death due to any cause. Assessed at 5 years.
  description: OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis.
  measure: EFS (event-free survival)
  time frame: Up to 5 years after first therapy.
  description: EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.
  measure: Event Free Survival (event-free survival) Rate
  time frame: From date of first received neoadjuvant therapy to 1 years after neoadjuvant.
  description: EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.
  measure: Event Free Survival (event-free survival) Rate
  time frame: From date of first received neoadjuvant therapy to 2 years after neoadjuvant.
  description: EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.
  measure: Event Free Survival (event-free survival) Rate
  time frame: From date of first received neoadjuvant therapy to 5 years after neoadjuvant.
  description: EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.
  measure: Major Pathological Response (MPR)
  time frame: Within 2 weeks after surgery
  description: defined as ≤10% of viable tumor cells
  measure: Patterns of Relapse
  time frame: Within 5 years after surgery
  description: Relapse was defined as disease recurrence at any site.
  arm group label: Resectable stage I-III NSCLC
  description: Patients with NSCLC patients receiving neoadjuvant therapy and undergoing surgeries. Resectability after neoadjuvant therapy is judged by the multidisciplinary team of thoracic surgeon, oncologist and radiation oncologist.
  intervention type: Drug
  intervention name: Neoadjuvant immunochemotherapy
  description: Patients with operable stage I-III NSCLC who have previously undergone platinum drugs and immune checkpoint inhibitors(Anti PD-1) and then undergone radical surgery
  arm group label: Resectable stage I-III NSCLC
  other name: Neoadjuvant immunotherapy
  intervention type: Drug
  intervention name: Neoadjuvant chemotherapy
  description: Patients with operable stage I-III NSCLC who have previously undergone platinum-based chemotherapy regimens and then undergone radical surgery
  arm group label: Resectable stage I-III NSCLC
  other name: Neoadjuvant platinum-based doublet chemotherapy
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jie He, Dr.
  role: Study Chair
  affiliation: Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  last name: Jie He, Dr.
  phone: 010-87788863
  email: prof.jiehe@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Immunomodulating Agents