<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/NCT03029858</url>
  </required_header>
  <id_info>
    <org_study_id>CTONG1605</org_study_id>
    <secondary_id>ESR-16-12177</secondary_id>
    <nct_id>NCT03029858</nct_id>
  </id_info>
  <brief_title>PD-L1 and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced NSCLC Patients</brief_title>
  <acronym>ATHENE</acronym>
  <official_title>Programmed Death-ligand 1(PD-L1) and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Association of Clinical Trials</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Association of Clinical Trials</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will investigate whether PD-L1 and other immuno-markers will be influenced by&#xD;
      osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive&#xD;
      advanced NSCLC patients. In addition, we will explore whether PD-L1 and other immuno-markers&#xD;
      can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the&#xD;
      time of PD due to osimertinib resistance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib&#xD;
      treatment in advanced EGFR T790M positive advanced NSCLC patients.&#xD;
&#xD;
      explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of&#xD;
      subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib&#xD;
      resistance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure PD-L1 value</measure>
    <time_frame>baseline and PD，up to 24 months</time_frame>
    <description>Measure PD-L1 value Change by tumor cells（TC）/immune cells(IC) staining from the baseline to progressive disease（PD）</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure PD-L1 expression positive rate (%)</measure>
    <time_frame>baseline and PD，up to 24 months</time_frame>
    <description>Measure PD-L1 expression positive rate (%) change from the baseline to progressive disease（PD）</description>
  </primary_outcome>
  <enrollment type="Anticipated">155</enrollment>
  <condition>Small Cell Lung Cancer, Polygonal Type</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No interventions will be taken in this Observational study</intervention_name>
    <description>TAGRISSO(osimertinib/AZD9291）</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor Formaldehyde Fixed-Paraffin Embedded (FFPE) tissue specimen collection • Tumor FFPE&#xD;
      tissue specimen will be at least collected at baseline, disease progression and Response&#xD;
      (optional) in sufficient amount (10 FFPE slices, thickness 4um, tumor cells≥25% and the area&#xD;
      of necrotic tissues&lt;10%).&#xD;
&#xD;
      Blood specimen collection(optional)&#xD;
&#xD;
      • The plasma specimen requirements for 10 ml blood will be collected at least at baseline,&#xD;
      disease progression, and every 6 weeks, which is for detecting tumor mutation burden by&#xD;
      QIAGEN Mix-561-Match Panel (561genes).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients (≥18 years old) with locally advanced (stage IIIB) or metastatic (stage IV)&#xD;
        NSCLC with confirmed T790M mutation, who have received prior EGFR-TKI therapy，These&#xD;
        patients are those who were enrolled in ASTRIS（Real World Treatment Study of AZD9291 for&#xD;
        Advanced/Metastatic EGFR T790M Mutation NSCLC） or patients who were eligible for the ASTRIS&#xD;
        study.&#xD;
&#xD;
        The study is a post observational study for ASTRIS study，and the patients would not take&#xD;
        Osimertinib in this study any more.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient enrolled in ASTRIS or patient who are eligible for the ASTRIS study.&#xD;
&#xD;
          2. The patient is willing to provide informed consent form to provide specimen before&#xD;
             osimertinib treatment and at the time of PD.&#xD;
&#xD;
          3. Patients must be able to undergo a fresh tumor biopsy during screening or to provide&#xD;
             an available tumor sample taken &lt;2 months prior to screening.&#xD;
&#xD;
          4. Fine needle aspirate specimens are not acceptable.&#xD;
&#xD;
          5. Specimens from metastatic bone lesions are typically unacceptable unless there is&#xD;
             confirmed soft tissue component.&#xD;
&#xD;
          6. The tumor specimen submitted to establish eligibility should be of sufficient quantity&#xD;
             to allow for PD-L1 IHC and other biomarker analyses (if applicable) and is preferred&#xD;
             in formalin-fixed paraffin embedded blocks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient does not have sufficient tumor tissue specimen available for detection.&#xD;
&#xD;
          2. The Patient who is unwilling to use the existing data from medical practice for&#xD;
             scientific research.&#xD;
&#xD;
          3. The patient who received immunotherapy therapy before.&#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>Shun Lu, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Chest hospital of Shanghai Jiaotong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shun Lu, M.D</last_name>
    <phone>86-13601813062</phone>
    <email>shun_lu@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Principal Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The second affiliated hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jianhua Chang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Chest Hospital Oncology dept.</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Shun Lu</last_name>
      <phone>+86 13601813062</phone>
      <email>shun_lu@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Chest Hospital Respiratory dept.</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Liyan Jiang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The first Affiliated hospital of Zhejiang University, Thoracic Oncology Dept.</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first Affiliated hospital of Zhejiang University，Respiratory dept.</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The second Affiliated hospital of Zhejiang University of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Taizhou Hospital</name>
      <address>
        <city>Taizhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</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>


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/NCT03029858
org study id: CTONG1605
secondary id: ESR-16-12177
nct id: NCT03029858
lead sponsor: 
has dmc: No
The study will investigate whether PD-L1 and other immuno-markers will be influenced by
      osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive
      advanced NSCLC patients. In addition, we will explore whether PD-L1 and other immuno-markers
      can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the
      time of PD due to osimertinib resistance.
Investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib
      treatment in advanced EGFR T790M positive advanced NSCLC patients.

      explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of
      subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib
      resistance.
observational model: Case-Only
time perspective: Other
measure: Measure PD-L1 value
time frame: baseline and PD，up to 24 months
description: Measure PD-L1 value Change by tumor cells（TC）/immune cells(IC) staining from the baseline to progressive disease（PD）
measure: Measure PD-L1 expression positive rate (%)
time frame: baseline and PD，up to 24 months
description: Measure PD-L1 expression positive rate (%) change from the baseline to progressive disease（PD）
intervention type: Other
intervention name: No interventions will be taken in this Observational study
description: TAGRISSO(osimertinib/AZD9291）
Tumor Formaldehyde Fixed-Paraffin Embedded (FFPE) tissue specimen collection • Tumor FFPE
      tissue specimen will be at least collected at baseline, disease progression and Response
      (optional) in sufficient amount (10 FFPE slices, thickness 4um, tumor cells≥25% and the area
      of necrotic tissues<10%).

      Blood specimen collection(optional)

      • The plasma specimen requirements for 10 ml blood will be collected at least at baseline,
      disease progression, and every 6 weeks, which is for detecting tumor mutation burden by
      QIAGEN Mix-561-Match Panel (561genes).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shun Lu, M.D
role: Principal Investigator
affiliation: Shanghai Chest hospital of Shanghai Jiaotong University
last name: Shun Lu, M.D
phone: 86-13601813062
email: shun_lu@hotmail.com
facility: 
facility: 
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contact: 
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contact: 
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country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
sharing ipd: No