<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/NCT01723878</url>
  </required_header>
  <id_info>
    <org_study_id>ML28361</org_study_id>
    <nct_id>NCT01723878</nct_id>
  </id_info>
  <brief_title>ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations</brief_title>
  <official_title>Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This observational study will evaluate the patterns of disease progression in patients with&#xD;
      locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating&#xD;
      mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed&#xD;
      for up to 12 months after progression of disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2013</start_date>
  <completion_date type="Actual">June 20, 2017</completion_date>
  <primary_completion_date type="Actual">June 20, 2017</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>Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate, tumor assessments according to RECIST v1.1 criteria</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One-year overall survival (from initiation of treatment to 12 months after disease progression)</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exposure (dosage/duration) with first-line Tarceva in clinical practice</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatments used after disease progression in clinical practice</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">144</enrollment>
  <condition>Non-Squamous Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with advanced non-small cell lung cancer (NSCLC) with EGFR activating mutations&#xD;
        receiving first-line treatment with Tarceva&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV)&#xD;
             non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in&#xD;
             clinical practice according to RECIST criteria&#xD;
&#xD;
          -  EGFR mutation-positive disease according to local laboratory testing&#xD;
&#xD;
          -  Patients on treatment with Tarceva monotherapy as first-line treatment according to&#xD;
             the physician's usual practice&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or&#xD;
             adjuvant chemotherapy is allowed as long as it was finalized &gt;6 months prior to&#xD;
             receiving Tarceva&#xD;
&#xD;
          -  Participation in another clinical study&#xD;
&#xD;
          -  Patients could have received radiotherapy as long as the irradiated lesion was not the&#xD;
             only lesion for evaluating response and a long as the radiotherapy was completed&#xD;
             before initiating Tarceva 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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Virgen de los Lirios; Servicio de Oncologia</name>
      <address>
        <city>Alcoy</city>
        <state>Alicante</state>
        <zip>03804</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Granollers; Servicio de Oncologia</name>
      <address>
        <city>Granollers</city>
        <state>Barcelona</state>
        <zip>08400</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Mutua de Terrassa; Servicio de Oncologia</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona</state>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta del Mar; Servicio de Oncologia</name>
      <address>
        <city>Cádiz</city>
        <state>Cadiz</state>
        <zip>11009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marques de Valdecilla; Servicio de Oncologia</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infanta Sofia; Servico de Oncologia</name>
      <address>
        <city>San Sebastian de Los Reyes</city>
        <state>Guipuzcoa</state>
        <zip>28702</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Donostia; Servicio de Oncologia Medica</name>
      <address>
        <city>San Sebastian</city>
        <state>Guipuzcoa</state>
        <zip>20080</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Espases; Servicio de Oncologia</name>
      <address>
        <city>Palma De Mallorca</city>
        <state>Islas Baleares</state>
        <zip>07014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Llatzer; Servicio de Oncologia</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Islas Baleares</state>
        <zip>07198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Lanzarote</name>
      <address>
        <city>Lanzarote</city>
        <state>Las Palmas</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>Las Palmas</state>
        <zip>35020</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Principe de Asturias; Servicio de Oncologia</name>
      <address>
        <city>Alcala de Henares</city>
        <state>Madrid</state>
        <zip>28805</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Hospital de Alcorcon; Servicio de Oncologia</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Henares; Servicio de Oncologia</name>
      <address>
        <city>Coslada</city>
        <state>Madrid</state>
        <zip>28822</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Meixoeiro</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36214</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias (HUC)</name>
      <address>
        <city>La Laguna (Tenerife)</city>
        <state>Tenerife</state>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia</name>
      <address>
        <city>Santa Cruz de Tenerife</city>
        <state>Tenerife</state>
        <zip>38010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sagunto; Servicio de Oncologia</name>
      <address>
        <city>Sagunto</city>
        <state>Valencia</state>
        <zip>46520</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Lluis Alcanys; Servicio de Oncologia</name>
      <address>
        <city>Xativa</city>
        <state>Valencia</state>
        <zip>46800</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cruces; Servicio de Oncologia</name>
      <address>
        <city>Barakaldo</city>
        <state>Vizcaya</state>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia; Servicio de Oncologia</name>
      <address>
        <city>Cordoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario San Cecilio; Servicio de Oncologia</name>
      <address>
        <city>Granada</city>
        <zip>18003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia</name>
      <address>
        <city>Jaen</city>
        <zip>23007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Asistencial Universitario de Leon; Servicio de Oncologia</name>
      <address>
        <city>Leon</city>
        <zip>24071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Xeral-Cies</name>
      <address>
        <city>Lugo</city>
        <zip>27004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Mostoles;Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28935</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia</name>
      <address>
        <city>Murcia</city>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Orense; Servicio de Oncologia</name>
      <address>
        <city>Orense</city>
        <zip>32005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Salamanca; Servicio de Oncologia</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Segovia; Servicio de Oncologia</name>
      <address>
        <city>Segovia</city>
        <zip>40002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena; Servicio de Oncologia</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Teruel Obispo Polanco; Servicio Oncologia</name>
      <address>
        <city>Teruel</city>
        <zip>44002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr. Peset; Servicio de Oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valladolid; Servicio de Oncologia</name>
      <address>
        <city>Valladolid</city>
        <zip>47005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia</name>
      <address>
        <city>Zamora</city>
        <zip>49021</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet; Servicio Oncologia</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 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>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_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/NCT01723878
org study id: ML28361
nct id: NCT01723878
lead sponsor: 
This observational study will evaluate the patterns of disease progression in patients with
      locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating
      mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed
      for up to 12 months after progression of disease.
observational model: Cohort
time perspective: Prospective
measure: Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics
time frame: 3 years
measure: Objective response rate, tumor assessments according to RECIST v1.1 criteria
time frame: 3 years
measure: One-year overall survival (from initiation of treatment to 12 months after disease progression)
time frame: 3 years
measure: Time to progression
time frame: 3 years
measure: Exposure (dosage/duration) with first-line Tarceva in clinical practice
time frame: 3 years
measure: Safety: Incidence of adverse events
time frame: 3 years
measure: Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression
time frame: 3 years
measure: Treatments used after disease progression in clinical practice
time frame: 3 years
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Spain
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung