<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/NCT03761901</url>
  </required_header>
  <id_info>
    <org_study_id>D5161R00007</org_study_id>
    <nct_id>NCT03761901</nct_id>
  </id_info>
  <brief_title>Study to Describe Treatment Patterns and Outcomes in EGFRm NSCLC Patients in Belgium</brief_title>
  <acronym>REVEAL</acronym>
  <official_title>REtrospective, obserVational Study to Describe the Treatment Patterns and Outcomes of Epidermal Growth Factor Receptor Mutant (EGFRm) Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Patients in Belgium</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective, observational, multicentre study to evaluate treatment patterns and&#xD;
      outcomes of patients diagnosed with locally advanced or metastatic EGFRm NSCLC in Belgium&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2018</start_date>
  <completion_date type="Actual">June 19, 2019</completion_date>
  <primary_completion_date type="Actual">June 19, 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>demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017</measure>
    <time_frame>28 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>NSCLC characteristics at diagnosis between 1 september 2015 and 31 December 2017</measure>
    <time_frame>28 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>NSCLC disease characteristics at start of 2L or 3L treatment during observation window</measure>
    <time_frame>36 months</time_frame>
    <description>observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Type of treatment received during 1L, 2L or 3L treatment during the observation window</measure>
    <time_frame>36 months</time_frame>
    <description>observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time on treatment during 1L, 2L or 3L treatment during the observation window</measure>
    <time_frame>36 months</time_frame>
    <description>observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients receiving a definitive, systemic therapy for NSCLC or no definitive, systemic therapy for NSCLC/best supportive care treatment after progression on their previous therapy</measure>
    <time_frame>36 months</time_frame>
    <description>observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reason for discontinuation after 1L, 2L or 3L treatment during observation window</measure>
    <time_frame>36 months</time_frame>
    <description>observation window: between date of diagnosis until the data cut-off, 1 september 2018, end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EGFR testing characteristics at diagnosis between 1 september 2015 and 31 December 2017</measure>
    <time_frame>28 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>EGFR testing characteristics after progression on previous treatment</measure>
    <time_frame>36 months</time_frame>
    <description>observation window: between date of diagnosis until the data cut-off, 01 September 2018 until end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PFS for 1L, 2L or 3L treatment during the observation window</measure>
    <time_frame>36 months</time_frame>
    <description>observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-treatment discontinuation for 1L, 2L and 3L treatment during the observation window</measure>
    <time_frame>36 months</time_frame>
    <description>observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to start of subsequent treatment after 1L and 2L treatment during the observation window</measure>
    <time_frame>36 months</time_frame>
    <description>observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS during observation window</measure>
    <time_frame>36 months</time_frame>
    <description>OS will be measured overall for all EGFRm NSCLC patients and depending on receipt of Osimertinib treatment and line of Osimertinib treatment.&#xD;
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first.&#xD;
Kaplan-Meier analysis will be used.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">141</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>Patients with EGFR mutation positive NSCLC</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1L treatment</intervention_name>
    <description>chemotherapy, EGFR TKI, immunotherapy, other</description>
    <arm_group_label>Patients with EGFR mutation positive NSCLC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2L Treatment</intervention_name>
    <description>Chemotherapy, EGFR TKI, immunotherapy, other</description>
    <arm_group_label>Patients with EGFR mutation positive NSCLC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3L treatment</intervention_name>
    <description>chemotherapy, EGFR TKI, immunotherapy, other</description>
    <arm_group_label>Patients with EGFR mutation positive NSCLC</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients diagnosed with advanced or metastatic EGFRm NSCLC between 1 september 2015&#xD;
        and 31 December 2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged at least 18 years&#xD;
&#xD;
          -  Pathologically confirmed NSCLC&#xD;
&#xD;
          -  Tumour harbours a mutation of EGFR&#xD;
&#xD;
          -  Diagnosis (radiologically or pathologically confirmed) of locally advanced or&#xD;
             metastatic NSCLC, not amenable to curative surgery or chemoradiotherapy between 01&#xD;
             September 2015 and 31 December 2017&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No follow-up data available after diagnosis of locally advanced or metastatic EGFRm&#xD;
             NSCLC&#xD;
&#xD;
          -  Patients who objected to participation to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Antwerpen</city>
        <zip>2020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bouge</city>
        <zip>5004</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mechelen</city>
        <zip>2800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sint-Niklaas</city>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sint-Truiden</city>
        <zip>3800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Turnhout</city>
        <zip>2300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D5161R00007&amp;amp;attachmentIdentifier=872df4e2-12ee-4617-83cd-e34e9d2877b3&amp;amp;fileName=REVEAL_Clinical_Study_Report_redacted_synopsis_(26_Feb_2020).pdf&amp;amp;versionIdentifier=</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>May 7, 2020</last_update_submitted>
  <last_update_submitted_qc>May 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EGFRm</keyword>
  <keyword>NSCLC</keyword>
  <keyword>locally advanced</keyword>
  <keyword>metastatic</keyword>
  <keyword>lung cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03761901
org study id: D5161R00007
nct id: NCT03761901
lead sponsor: 
has dmc: No
This is a retrospective, observational, multicentre study to evaluate treatment patterns and
      outcomes of patients diagnosed with locally advanced or metastatic EGFRm NSCLC in Belgium
observational model: Cohort
time perspective: Retrospective
measure: demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017
time frame: 28 months
measure: NSCLC characteristics at diagnosis between 1 september 2015 and 31 December 2017
time frame: 28 months
measure: NSCLC disease characteristics at start of 2L or 3L treatment during observation window
time frame: 36 months
description: observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
measure: Type of treatment received during 1L, 2L or 3L treatment during the observation window
time frame: 36 months
description: observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
measure: Time on treatment during 1L, 2L or 3L treatment during the observation window
time frame: 36 months
description: observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
measure: Proportion of patients receiving a definitive, systemic therapy for NSCLC or no definitive, systemic therapy for NSCLC/best supportive care treatment after progression on their previous therapy
time frame: 36 months
description: observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
measure: Reason for discontinuation after 1L, 2L or 3L treatment during observation window
time frame: 36 months
description: observation window: between date of diagnosis until the data cut-off, 1 september 2018, end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.
measure: EGFR testing characteristics at diagnosis between 1 september 2015 and 31 December 2017
time frame: 28 months
measure: EGFR testing characteristics after progression on previous treatment
time frame: 36 months
description: observation window: between date of diagnosis until the data cut-off, 01 September 2018 until end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.
measure: PFS for 1L, 2L or 3L treatment during the observation window
time frame: 36 months
description: observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.
measure: Time-to-treatment discontinuation for 1L, 2L and 3L treatment during the observation window
time frame: 36 months
description: observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.
measure: Time to start of subsequent treatment after 1L and 2L treatment during the observation window
time frame: 36 months
description: observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.
measure: OS during observation window
time frame: 36 months
description: OS will be measured overall for all EGFRm NSCLC patients and depending on receipt of Osimertinib treatment and line of Osimertinib treatment.
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first.
Kaplan-Meier analysis will be used.
arm group label: Patients with EGFR mutation positive NSCLC
intervention type: Drug
intervention name: 1L treatment
description: chemotherapy, EGFR TKI, immunotherapy, other
arm group label: Patients with EGFR mutation positive NSCLC
intervention type: Drug
intervention name: 2L Treatment
description: Chemotherapy, EGFR TKI, immunotherapy, other
arm group label: Patients with EGFR mutation positive NSCLC
intervention type: Drug
intervention name: 3L treatment
description: chemotherapy, EGFR TKI, immunotherapy, other
arm group label: Patients with EGFR mutation positive NSCLC
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Belgium
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5161R00007&amp;attachmentIdentifier=872df4e2-12ee-4617-83cd-e34e9d2877b3&amp;fileName=REVEAL_Clinical_Study_Report_redacted_synopsis_(26_Feb_2020).pdf&amp;versionIdentifier=
description: Related Info
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung