<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/NCT03228368</url>
  </required_header>
  <id_info>
    <org_study_id>TCR-1</org_study_id>
    <nct_id>NCT03228368</nct_id>
  </id_info>
  <brief_title>The Predicted Potential of Quantitative T Cell Repertoire(TCR) in Anti-PD-L1 Treatment in NSCLC Patients</brief_title>
  <official_title>The Predicted Potential of Quantitative T Cell Repertoire(TCR) Analysis Using Next-generation Sequencing (NGS) in Anti-PD-L1 Treatment in Non Small Cell Lung（NSCLC) Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Geneplus-Beijing Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital of Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the predicted potential of quantitative T cell repertoire&#xD;
      (TCR) of T cell receptor chains using next-generation sequencing (NGS) in the treatment of&#xD;
      the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab in participants with locally&#xD;
      advanced or metastatic NSCLC who have progressed during or following a platinum-containing&#xD;
      regimen. Treatment may continue until disease progression or unacceptable toxicity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>T cell repertoire</measure>
    <time_frame>From Screening until disease progression, death, or loss to follow-up (up to approximately 3 years overall)</time_frame>
    <description>Change of T cell receptor repertoire during Anti-PL-L1 treatment.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Atezolizumab (MPDL3280)</arm_group_label>
    <description>Atezolizumab 1200 milligrams (mg) will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab (MPDL3280A)</intervention_name>
    <description>anti-programmed death-ligand 1 (PD-L1) antibody</description>
    <arm_group_label>Atezolizumab (MPDL3280)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed of locally advanced or metastatic non small cell lung cancer progressed&#xD;
        during or following treatment with a prior platinum-containing regimen and subsequently&#xD;
        recevied atezolizumab.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically documented, locally advanced or metastatic NSCLC&#xD;
&#xD;
          -  Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or at&#xD;
             least 12 unstained, freshly cut serial sections with associated pathology report that&#xD;
             are evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR)&#xD;
             mutation status prior to enrollment, except for known sensitizing EGFR mutations in&#xD;
             which case 10 unstained slides are required and there is no need for central testing&#xD;
             of EGFR mutation status&#xD;
&#xD;
          -  Disease progression during or following treatment with a prior platinum-containing&#xD;
             regimen for locally advanced, unresectable, inoperable, or metastatic NSCLC, or&#xD;
             disease recurrence within 6 months of treatment with a platinum-based adjuvant and/or&#xD;
             neoadjuvant regimen or combined modality with curative intent&#xD;
&#xD;
          -  Measurable disease per RECIST Version 1.1&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Life expectancy greater than or equal to (&gt;/=) 12 weeks&#xD;
&#xD;
          -  Adequate hematologic and end organ function&#xD;
&#xD;
          -  Agreement to remain abstinent or use contraceptive methods among women of childbearing&#xD;
             potential or male partners of women of childbearing potential&#xD;
&#xD;
          -  Recovery from all acute toxicities from previous therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active or untreated central nervous system (CNS) metastases&#xD;
&#xD;
          -  Spinal cord compression not definitively treated or not clinically stable&#xD;
&#xD;
          -  Leptomeningeal disease&#xD;
&#xD;
          -  Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage&#xD;
&#xD;
          -  Uncontrolled tumor-related pain&#xD;
&#xD;
          -  Uncontrolled hypercalcemia&#xD;
&#xD;
          -  Malignancies other than NSCLC within 5 years prior to randomization, except for those&#xD;
             curatively treated with negligible risk of metastasis or death&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Significant cardiovascular, pulmonary, or autoimmune disease&#xD;
&#xD;
          -  Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2&#xD;
             weeks prior to randomization&#xD;
&#xD;
          -  Prior treatment with or hypersensitivity to study drug(s) or related compounds&#xD;
&#xD;
          -  Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors&#xD;
&#xD;
          -  Prior allogeneic bone marrow or solid organ transplant&#xD;
&#xD;
          -  Known PD-L1 expression status from other clinical studies&#xD;
&#xD;
          -  Positive human immunodeficiency virus (HIV) or hepatitis B or C&#xD;
&#xD;
          -  Receipt of a live attenuated vaccine within 4 weeks prior to randomization&#xD;
&#xD;
          -  Treatment with systemic immunomodulators within 4 weeks or five half-lives (whichever&#xD;
             is shorter) prior to randomization&#xD;
&#xD;
          -  Treatment with systemic corticosteroids within 2 weeks prior to randomization&#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_contact>
    <last_name>Director of Department of Thoracic Oncology</last_name>
    <email>doczq.2008@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>The First Affiliated Hospital of College of Medicine, Zhejiang</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of College of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Chen</last_name>
      <email>cli6274@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>June 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 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>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03228368
org study id: TCR-1
nct id: NCT03228368
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study is designed to evaluate the predicted potential of quantitative T cell repertoire
      (TCR) of T cell receptor chains using next-generation sequencing (NGS) in the treatment of
      the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab in participants with locally
      advanced or metastatic NSCLC who have progressed during or following a platinum-containing
      regimen. Treatment may continue until disease progression or unacceptable toxicity.
observational model: Case-Only
time perspective: Prospective
measure: T cell repertoire
time frame: From Screening until disease progression, death, or loss to follow-up (up to approximately 3 years overall)
description: Change of T cell receptor repertoire during Anti-PL-L1 treatment.
arm group label: Atezolizumab (MPDL3280)
description: Atezolizumab 1200 milligrams (mg) will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.
intervention type: Drug
intervention name: Atezolizumab (MPDL3280A)
description: anti-programmed death-ligand 1 (PD-L1) antibody
arm group label: Atezolizumab (MPDL3280)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Director of Department of Thoracic Oncology
email: doczq.2008@163.com
last name: The First Affiliated Hospital of College of Medicine, Zhejiang
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Atezolizumab