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/NCT05991895</url>
    </required_header>
    <id_info>
      <org_study_id>IRU-RWS-001</org_study_id>
      <nct_id>NCT05991895</nct_id>
    </id_info>
    <brief_title>Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer</brief_title>
    <official_title>Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jinming Yu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shandong Cancer Hospital and Institute</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>
        This study is a national multicenter real-world investigation aimed at evaluating the&#xD;
        real-world effectiveness and safety of Iruplinalkib in the treatment of ALK-positive NSCLC in&#xD;
        China.&#xD;
  &#xD;
        The study aims to enroll ALK-positive NSCLC patients who have undergone treatment with&#xD;
        Iruplinalkib prior to enrollment. Demographic information, medical history,&#xD;
        Iruplinalkib-containing treatment regimens, clinical outcomes, adverse events, and related&#xD;
        data will be collected for all enrolled patients.&#xD;
  &#xD;
        As this study is a real-world investigation, treatment procedures, visit schedules, and&#xD;
        examinations will be based on the routine clinical practice of physicians. The primary&#xD;
        sources of data for this study will mainly consist of patients' routine medical records or&#xD;
        healthcare documentation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 24, 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">July 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Adverse Events (AEs)</measure>
      <time_frame>36 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>Non-small Cell Lung Cancer (NSCLC)</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Iruplinalkib</intervention_name>
      <description>Iruplinalkib is administered orally with approximately fixed dosing times each day. The recommended dosage is once daily, on an empty stomach or with food, at 60 mg per dose for the first 1 to 7 days. If tolerated, the dosage is increased to 180 mg per dose starting from the 8th day.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          ALK-positive non-small cell lung cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients willingly contribute their clinical data for this study&#xD;
  &#xD;
            -  Patients with ALK-positive non-small cell lung cancer&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Patients who have undergone treatment with Iruplinalkib.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known pregnant or lactating females&#xD;
  &#xD;
            -  Patients with interstitial lung diseases, drug-related pneumonitis, or radiation&#xD;
               pneumonitis require ongoing medical intervention.&#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>JinMing Yu, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shandong Cancer Hospital and Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jinming Yu, PhD</last_name>
      <phone>8613806406293</phone>
      <email>jn7984729@public.jn.sd.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Linlin Wang, PhD</last_name>
      <phone>8613793187739</phone>
      <email>wanglinlinatjn@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shandong Cancer Hospital and Institute</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Linlin Wang</last_name>
        <phone>+8613793187739</phone>
        <email>wanglinlinatjn@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Shandong Cancer Hospital and Institute</investigator_affiliation>
      <investigator_full_name>Jinming Yu</investigator_full_name>
      <investigator_title>Director of the hospital</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>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/NCT05991895
  org study id: IRU-RWS-001
  nct id: NCT05991895
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a national multicenter real-world investigation aimed at evaluating the
        real-world effectiveness and safety of Iruplinalkib in the treatment of ALK-positive NSCLC in
        China.
  
        The study aims to enroll ALK-positive NSCLC patients who have undergone treatment with
        Iruplinalkib prior to enrollment. Demographic information, medical history,
        Iruplinalkib-containing treatment regimens, clinical outcomes, adverse events, and related
        data will be collected for all enrolled patients.
  
        As this study is a real-world investigation, treatment procedures, visit schedules, and
        examinations will be based on the routine clinical practice of physicians. The primary
        sources of data for this study will mainly consist of patients' routine medical records or
        healthcare documentation.
  observational model: Cohort
  time perspective: Prospective
  measure: Adverse Events (AEs)
  time frame: 36 months
  intervention type: Drug
  intervention name: Iruplinalkib
  description: Iruplinalkib is administered orally with approximately fixed dosing times each day. The recommended dosage is once daily, on an empty stomach or with food, at 60 mg per dose for the first 1 to 7 days. If tolerated, the dosage is increased to 180 mg per dose starting from the 8th day.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: JinMing Yu, PhD
  role: Principal Investigator
  affiliation: Shandong Cancer Hospital and Institute
  last name: Jinming Yu, PhD
  phone: 8613806406293
  email: jn7984729@public.jn.sd.cn
  last name: Linlin Wang, PhD
  phone: 8613793187739
  email: wanglinlinatjn@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Shandong Cancer Hospital and Institute
  investigator full name: Jinming Yu
  investigator title: Director of the hospital
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung