<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/NCT03305133</url>
  </required_header>
  <id_info>
    <org_study_id>GFPC 03-2017</org_study_id>
    <nct_id>NCT03305133</nct_id>
  </id_info>
  <brief_title>Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC)</brief_title>
  <acronym>EPNEC</acronym>
  <official_title>Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Francais De Pneumo-Cancerologie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe Francais De Pneumo-Cancerologie</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>
      Observational, multicentre, retrospective study on patients taken care according to the&#xD;
      national guidelines. The objective is to define, after the diagnosis confirmation, the&#xD;
      frequency of PD-L1 expression in patients with large-cell lung neuroendocrine carcinoma&#xD;
      (NEC), whatever the stage of the disease, and to correlate this parameter to clinical data at&#xD;
      the time of diagnosis, therapeutic response and survival. Large-cell NECs present a bad&#xD;
      prognostic and there is no evidence of treatment for these patients with advanced disease in&#xD;
      second ligne of treatment at that time. To demonstrate the PD-L1 expression in this type of&#xD;
      cancer might have a major therapeutic impact in a close future to access immunotherapies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">October 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 14, 2018</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>Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)</measure>
    <time_frame>Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016</time_frame>
    <description>Determine the frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)in terms of percentage of tumor cells expressing PD-L1 in immunohistochemistry (IHC) at the time of diagnosis:&#xD;
The frequency of PD-L1 expression determined by IHC will be as follow:&#xD;
Negative PD-L1 tumours (&lt;1% of positive tumour cells)&#xD;
Positive PD-L1 tumours (&gt; or = to 1% of positive tumour cells)&#xD;
Low positive PD-L1 tumours (from 1% to 49% of positive tumour cells expressed)&#xD;
High positive PD-L1 tumours (&gt; or = 50% of positive tumour cells expressed)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of PD-L1 expression of tumour cells with clinical data</measure>
    <time_frame>Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016</time_frame>
    <description>Describe the disease at the time of diagnosis using TNM IASLC/UICC 2009 classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016</time_frame>
    <description>Objective Response Rate (ORR): best overall response of complete response (CR) or partial response (PR) to a first line of treatment using RECIST 1.1 criteria as assessed locally</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016</time_frame>
    <description>PFS of the first line of treatment using RECIST 1.1 criteria assessed locally defined as the time from first treatment start to disease progression or death for any cause expressed in months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016</time_frame>
    <description>OS defined as the time from first treatment start to death for any cause expressed in months</description>
  </secondary_outcome>
  <enrollment type="Actual">86</enrollment>
  <condition>Large Cell Lung Cancer</condition>
  <condition>Neuroendocrine Carcinoma of Lung (Diagnosis)</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Immunohistochemistry</intervention_name>
    <description>The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Slides (tumour materials) at diagnosis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting a large-cell NEC taken in charge by investigational centres between&#xD;
        January 1st, 2014 and December 31st, 2016.&#xD;
&#xD;
        Alive patients will be identified during disease follow-up visit as per the local current&#xD;
        practice and the study will be then proposed to them at that time.&#xD;
&#xD;
        For died patients, eligible patients will be identified by checking the files present at&#xD;
        site by the Principal Investigator.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged &gt; or = 18 years&#xD;
&#xD;
          -  Diagnosis of Large-cell NEC confirmed by centralised reading&#xD;
&#xD;
          -  Tumoral materials available and readable for PD-L1 labeling&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other type of Lung cancers&#xD;
&#xD;
          -  Tumoral material not available or not readable for centralised reading&#xD;
&#xD;
          -  Tumoral material not available or not readable for PD-L1 labeling&#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>Dominque Arpin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier D Argenteuil</name>
      <address>
        <city>Argenteuil</city>
        <state>VAL D'oise</state>
        <zip>95100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 12</name>
      <address>
        <city>Aix En Provence</city>
        <zip>13100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Angers</city>
        <zip>49033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 05</name>
      <address>
        <city>Bastia</city>
        <zip>20200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 22</name>
      <address>
        <city>Beauvais</city>
        <zip>60021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier du Morvan</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 43</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 48</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 33</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 32</name>
      <address>
        <city>Elbeuf</city>
        <zip>76503</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 04</name>
      <address>
        <city>GAP</city>
        <zip>05000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Les Oudairies</name>
      <address>
        <city>La Roche Sur Yon</city>
        <zip>85000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire DUPUYTREN</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital du Cluzeau</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 00</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Lyon</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 25</name>
      <address>
        <city>Mantes La Jolie</city>
        <zip>78200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 06</name>
      <address>
        <city>Marseille</city>
        <zip>13274</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 01</name>
      <address>
        <city>Meaux</city>
        <zip>77108</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 42</name>
      <address>
        <city>Orleans</city>
        <zip>45032</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 26</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 19</name>
      <address>
        <city>Perigueux</city>
        <zip>24019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 02</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 18</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 17</name>
      <address>
        <city>Rouen</city>
        <zip>76233</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 14</name>
      <address>
        <city>Toulon</city>
        <zip>83800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 11</name>
      <address>
        <city>Villefranche Sur Saone</city>
        <zip>69655</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>March 11, 2020</last_update_submitted>
  <last_update_submitted_qc>March 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2020</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</mesh_term>
    <mesh_term>Carcinoma, Neuroendocrine</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_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/NCT03305133
org study id: GFPC 03-2017
nct id: NCT03305133
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational, multicentre, retrospective study on patients taken care according to the
      national guidelines. The objective is to define, after the diagnosis confirmation, the
      frequency of PD-L1 expression in patients with large-cell lung neuroendocrine carcinoma
      (NEC), whatever the stage of the disease, and to correlate this parameter to clinical data at
      the time of diagnosis, therapeutic response and survival. Large-cell NECs present a bad
      prognostic and there is no evidence of treatment for these patients with advanced disease in
      second ligne of treatment at that time. To demonstrate the PD-L1 expression in this type of
      cancer might have a major therapeutic impact in a close future to access immunotherapies.
observational model: Cohort
time perspective: Retrospective
measure: Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)
time frame: Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
description: Determine the frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)in terms of percentage of tumor cells expressing PD-L1 in immunohistochemistry (IHC) at the time of diagnosis:
The frequency of PD-L1 expression determined by IHC will be as follow:
Negative PD-L1 tumours (<1% of positive tumour cells)
Positive PD-L1 tumours (> or = to 1% of positive tumour cells)
Low positive PD-L1 tumours (from 1% to 49% of positive tumour cells expressed)
High positive PD-L1 tumours (> or = 50% of positive tumour cells expressed)
measure: Correlation of PD-L1 expression of tumour cells with clinical data
time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
description: Describe the disease at the time of diagnosis using TNM IASLC/UICC 2009 classification
measure: Objective Response Rate (ORR)
time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
description: Objective Response Rate (ORR): best overall response of complete response (CR) or partial response (PR) to a first line of treatment using RECIST 1.1 criteria as assessed locally
measure: Progression-free survival (PFS)
time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
description: PFS of the first line of treatment using RECIST 1.1 criteria assessed locally defined as the time from first treatment start to disease progression or death for any cause expressed in months
measure: Overall survival (OS)
time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
description: OS defined as the time from first treatment start to death for any cause expressed in months
intervention type: Other
intervention name: Immunohistochemistry
description: The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.
Slides (tumour materials) at diagnosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominque Arpin, MD
role: Principal Investigator
affiliation: Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône
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country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Neuroendocrine
mesh term: Lung Neoplasms
sharing ipd: Undecided