<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/NCT02991274</url>
  </required_header>
  <id_info>
    <org_study_id>D5160C00041</org_study_id>
    <nct_id>NCT02991274</nct_id>
  </id_info>
  <brief_title>ARTEMIS DIANE T790M (An Amino Acid Substitution at Position 790 in EGFR, From a Threonine (T) to a Methionine (M)) Mutation at Hospital Laboratories in Comparison With Central Laboratory</brief_title>
  <official_title>A Study of T790M Mutation Testing in Patient Tissue and Blood With Various Detection Platforms at Hospital Laboratories in Comparison With Central Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</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>
      The study primary objective is to assess the concordance of T790M resistance mutation testing&#xD;
      from hospital-based laboratories with T790M resistance mutation testing from a central&#xD;
      laboratory.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center testing study. 800 patients from 80 different hospital sites will have&#xD;
      local T790M testing by different molecular testing platforms and have central testing by&#xD;
      Cobas platform. These two sets of data (local T790M testing and central T790M testing) will&#xD;
      be analysed and compared to assess the concordance of these T790M testing platforms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2017</start_date>
  <completion_date type="Actual">June 29, 2018</completion_date>
  <primary_completion_date type="Actual">June 29, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>the concordance of T790M mutation testing between the test in central and local labs</measure>
    <time_frame>within 1 -14 days after enrolled</time_frame>
    <description>Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The prevalence rate of T790M mutation based on the central lab testing</measure>
    <time_frame>within 1 -14 days after enrolled</time_frame>
    <description>Prevalence (%) = (number of patients with T790M mutation positive)/(total number of patients in the FAS)×100%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The sensitivity of each platform based on the local lab plasma testing</measure>
    <time_frame>within 1 -14 days after enrolled</time_frame>
    <description>Sensitivity (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on tissue test) ×100%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Specificity of each platform based on the local lab plasma testing</measure>
    <time_frame>within 1 -14 days after enrolled</time_frame>
    <description>Specificity (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on tissue test) ×100%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Positive predictive value of each platform based on the local lab plasma testing</measure>
    <time_frame>within 1 -14 days after enrolled</time_frame>
    <description>Positive predictive value (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on plasma test) ×100%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Negative predictive value of each platform based on the local lab plasma testing</measure>
    <time_frame>within 1 -14 days after enrolled</time_frame>
    <description>Negative predictive value (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on plasma test) ×100%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Concordance of each platform based on the local lab testing</measure>
    <time_frame>within 1 -14 days after enrolled</time_frame>
    <description>Concordance (%)=(number of patients with same T790M mutation status based on tissue and plasma tests)/(total number of patients in the FAS) ×100%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The prevalence of C797S (An amino acid substitution at position 797 in EGFR, from a Cysteine (C) to a Serine (S) ) resistance mutation based on the local lab testing</measure>
    <time_frame>within 1 -14 days after enrolled</time_frame>
    <description>Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rare EGFR mutation prevalence rate</measure>
    <time_frame>within 1-14 days after enrolled</time_frame>
    <description>Prevalence (%) = (number of patients with rare EGFR mutation positive)/(total number of patients in the FAS)×100%</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">897</enrollment>
  <condition>Locally Advanced or Metastatic EGFR(+) NSCLC Patients</condition>
  <arm_group>
    <arm_group_label>T790M mutation test</arm_group_label>
    <description>genomic testing of T790M mutation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>genomic testing of T790M mutation</intervention_name>
    <description>patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.</description>
    <arm_group_label>T790M mutation test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent or EC approve informed consent waiver prior to any study&#xD;
             specific procedures&#xD;
&#xD;
          2. Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or&#xD;
             metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy.&#xD;
&#xD;
          3. Patients who have progressed following prior therapy with an EGFR-TKI agent.&#xD;
&#xD;
          4. Patients who consent to provide tumour tissue and/or blood.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who disagree to participate this study.&#xD;
&#xD;
          2. Patients whose medical objection was recorded to use the existing data from medical&#xD;
             practice for scientific research.&#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>Caicun Zhou</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Pulmonary Hospital, Shanghai, China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jie He</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jie Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beijing</city>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changchun</city>
        <zip>130012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changchun</city>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chengdu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guangzhou</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Harbin</city>
        <zip>150049</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hefei</city>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hohhot</city>
        <zip>010017</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ji Nan</city>
        <zip>2501117</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kunming</city>
        <zip>650118</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Linhai</city>
        <zip>317000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nanchang</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nanjing</city>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Qingdao</city>
        <zip>266071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shenyang</city>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shenzhen</city>
        <zip>518020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Urumqi</city>
        <zip>830054</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wuhan</city>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wuhan</city>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Xi'an</city>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Xi'An</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yantai</city>
        <zip>264000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zhengzhou</city>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ürümqi</city>
        <zip>830000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>June 11, 2019</last_update_submitted>
  <last_update_submitted_qc>June 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T790M</keyword>
  <keyword>EGFR (Epidermal Growth Factor Receptor) mutation</keyword>
  <keyword>NSCLC</keyword>
  <!-- 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/NCT02991274
org study id: D5160C00041
nct id: NCT02991274
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study primary objective is to assess the concordance of T790M resistance mutation testing
      from hospital-based laboratories with T790M resistance mutation testing from a central
      laboratory.
This is a multi-center testing study. 800 patients from 80 different hospital sites will have
      local T790M testing by different molecular testing platforms and have central testing by
      Cobas platform. These two sets of data (local T790M testing and central T790M testing) will
      be analysed and compared to assess the concordance of these T790M testing platforms.
measure: the concordance of T790M mutation testing between the test in central and local labs
time frame: within 1 -14 days after enrolled
description: Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100%
measure: The prevalence rate of T790M mutation based on the central lab testing
time frame: within 1 -14 days after enrolled
description: Prevalence (%) = (number of patients with T790M mutation positive)/(total number of patients in the FAS)×100%
measure: The sensitivity of each platform based on the local lab plasma testing
time frame: within 1 -14 days after enrolled
description: Sensitivity (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on tissue test) ×100%
measure: The Specificity of each platform based on the local lab plasma testing
time frame: within 1 -14 days after enrolled
description: Specificity (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on tissue test) ×100%
measure: The Positive predictive value of each platform based on the local lab plasma testing
time frame: within 1 -14 days after enrolled
description: Positive predictive value (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on plasma test) ×100%
measure: The Negative predictive value of each platform based on the local lab plasma testing
time frame: within 1 -14 days after enrolled
description: Negative predictive value (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on plasma test) ×100%
measure: The Concordance of each platform based on the local lab testing
time frame: within 1 -14 days after enrolled
description: Concordance (%)=(number of patients with same T790M mutation status based on tissue and plasma tests)/(total number of patients in the FAS) ×100%
measure: The prevalence of C797S (An amino acid substitution at position 797 in EGFR, from a Cysteine (C) to a Serine (S) ) resistance mutation based on the local lab testing
time frame: within 1 -14 days after enrolled
description: Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100%
measure: Rare EGFR mutation prevalence rate
time frame: within 1-14 days after enrolled
description: Prevalence (%) = (number of patients with rare EGFR mutation positive)/(total number of patients in the FAS)×100%
arm group label: T790M mutation test
description: genomic testing of T790M mutation
intervention type: Procedure
intervention name: genomic testing of T790M mutation
description: patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.
arm group label: T790M mutation test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Caicun Zhou
role: Principal Investigator
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
last name: Jie He
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Jie Wang
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor