<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/NCT03790397</url>
  </required_header>
  <id_info>
    <org_study_id>GECP 18/01_OSIREX</org_study_id>
    <nct_id>NCT03790397</nct_id>
  </id_info>
  <brief_title>Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive</brief_title>
  <acronym>OSIREX</acronym>
  <official_title>A Retrospective, Multicenter and Observational Study of Osimertinib Monotherapy Treatment in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive Who Have Received the Treatment Within the Special Use Medication Program in Spain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación GECP</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación GECP</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 is a retrospective, multicenter and observational study of Osimertinib monotherapy&#xD;
      treatment in Subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)&#xD;
      EGFR-T790M mutation-positive who have received the treatment within the Special Use&#xD;
      Medication Program (SUMP) in Spain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is based on the collection of data about the patients treated with Osimertinib&#xD;
      within the Special Use medication Program. the patienes participating in this&#xD;
      non-interventional study will not receive treatment in relation to the study.&#xD;
&#xD;
      Approximately a total of 270 patients will be included in this project from several Spanish&#xD;
      sites. Around 52 hospitals will participate in the study. the observation period is from&#xD;
      August 2016 to December 2018 and will include patients who started the treatment with&#xD;
      Osimertininb from August 2016 to April 2018.&#xD;
&#xD;
      The primary objective is to estimate the progression free survival of the Osimertinib&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2019</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>Progression free survival</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
    <description>To estimate the progression free survival of the Osimertinib Treatment</description>
  </primary_outcome>
  <enrollment type="Actual">169</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Osimertinib</intervention_name>
    <description>Patients treated with Osimertinib within the Special Use medication Program (SUMP).</description>
    <other_name>Tecentriq</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who have received Osimertinib in the SUMP in Spain.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Squamous or Non-Squamous, non-small cell lung cancer (NSCLC), Stage IIIb/IV&#xD;
             (histologically or cytologically confirmed), EGFRm/T790M, who received osimertinib&#xD;
             treatment within the Spanish special use medication program of Osimertinib (SUMP).&#xD;
&#xD;
          -  Alive patients must have signed, dated and IRB/EC-approved written informed consent&#xD;
             form in accordance with regulatory and institutional guidelines. This must be obtained&#xD;
             before the performance of any protocol-related procedures that are not part of normal&#xD;
             subject care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alive patients who do not want to sign and date an IRB/IEC-approved written informed&#xD;
             consent form.&#xD;
&#xD;
          -  Patients who were accepted in the SUMP, but did not receive treatment.&#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>Mariano Provencio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Puerta de Hierro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO Badalona</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Santiago</name>
      <address>
        <city>Santiago De Compostela</city>
        <state>Galicia</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruña</name>
      <address>
        <city>A Coruña</city>
        <state>La Coruña</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr. Negrín</name>
      <address>
        <city>Las Palmas De Gran Canaria</city>
        <state>Las Palmas</state>
        <zip>35010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Príncipe de Asturias</name>
      <address>
        <city>Alcalá De Henares</city>
        <state>Madrid</state>
        <zip>28805</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Getafe</name>
      <address>
        <city>Getafe</city>
        <state>Madrid</state>
        <zip>28905</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Mallorca</state>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Llàtzer</name>
      <address>
        <city>Palma De Mallorca</city>
        <state>Mallorca</state>
        <zip>07198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Vigo</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Lluís Alcanyís</name>
      <address>
        <city>Xàtiva</city>
        <state>Valencia</state>
        <zip>46800</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Albacete</name>
      <address>
        <city>Albacete</city>
        <zip>02006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Alicante</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Burgos</name>
      <address>
        <city>Burgos</city>
        <zip>09006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dr. Josep Trueta</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Guadalajara</name>
      <address>
        <city>Guadalajara</city>
        <zip>19002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Jaén</name>
      <address>
        <city>Jaén</city>
        <zip>23007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Asistencial Universitario de León</name>
      <address>
        <city>León</city>
        <zip>24071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Lucus Augusti</name>
      <address>
        <city>Lugo</city>
        <zip>27003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro</name>
      <address>
        <city>Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Málaga</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Salud</name>
      <address>
        <city>Toledo</city>
        <zip>45071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politécnic La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <zip>47003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.gecp.org</url>
    <description>Web page of the sponsor where users can find more information about Fundación GECP studies</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>June 1, 2022</last_update_submitted>
  <last_update_submitted_qc>June 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung Cancer, EGFR positive, NSCLC, Osimertinib</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osimertinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03790397
org study id: GECP 18/01_OSIREX
nct id: NCT03790397
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a retrospective, multicenter and observational study of Osimertinib monotherapy
      treatment in Subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
      EGFR-T790M mutation-positive who have received the treatment within the Special Use
      Medication Program (SUMP) in Spain.
The study is based on the collection of data about the patients treated with Osimertinib
      within the Special Use medication Program. the patienes participating in this
      non-interventional study will not receive treatment in relation to the study.

      Approximately a total of 270 patients will be included in this project from several Spanish
      sites. Around 52 hospitals will participate in the study. the observation period is from
      August 2016 to December 2018 and will include patients who started the treatment with
      Osimertininb from August 2016 to April 2018.

      The primary objective is to estimate the progression free survival of the Osimertinib
      treatment.
observational model: Cohort
time perspective: Retrospective
measure: Progression free survival
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
description: To estimate the progression free survival of the Osimertinib Treatment
intervention type: Drug
intervention name: Osimertinib
description: Patients treated with Osimertinib within the Special Use medication Program (SUMP).
other name: Tecentriq
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mariano Provencio, MD
role: Principal Investigator
affiliation: Hospital Universitario Puerta de Hierro
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country: Spain
url: http://www.gecp.org
description: Web page of the sponsor where users can find more information about Fundación GECP studies
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Osimertinib
sharing ipd: Undecided