<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/NCT03832348</url>
  </required_header>
  <id_info>
    <org_study_id>CHB18.05</org_study_id>
    <nct_id>NCT03832348</nct_id>
  </id_info>
  <brief_title>Dynamics of 18-FDG Uptake in Stage III/IV Non Small Cell Lung Cancer During First Line Pembrolizumab Treatment</brief_title>
  <acronym>iTEP1</acronym>
  <official_title>18-FDG Tumour Metabolism Changes in PDL1 Superior to 50% Stage III/IV Non Small Cell Lung Cancer During First Line Treatment With Pembrolizumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Henri Becquerel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Henri Becquerel</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 aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell&#xD;
      lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not&#xD;
      they differ according to treatment response at 3 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Immunotherapy with anti-PD1 antibody, such as Pembrolizumab, is widely used in the treatment&#xD;
      of stage III/IV non small cell lung cancer. In order to refine treatments and patients'&#xD;
      prognosis, early assessment of tumour response is needed.&#xD;
&#xD;
      The aim of this study is to describe the early tumour metabolic changes in non smal cell lung&#xD;
      cancer during first line treatment with pembrolizumab, and to evaluate whether or not they&#xD;
      differ according to treatment response.&#xD;
&#xD;
      Eligible patients with stage III/IV, PDL1&gt;50% NSCLC will receive pembrolizumab treatment as&#xD;
      per standard of care.&#xD;
&#xD;
      Tumour metabolism will be assessed by 18-FDG PETscan before each of the 3 first pembrolizumab&#xD;
      infusions. Treatment response will be determined by RECIST, irRC and mCHOI criteria at 3&#xD;
      months.&#xD;
&#xD;
      Prognostic and predictive value of baseline and dynamic metabolic parameters will be&#xD;
      assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 17, 2019</start_date>
  <completion_date type="Anticipated">December 17, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 17, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determination of progression by early PET scan</measure>
    <time_frame>3 months</time_frame>
    <description>Determination of non-response of treatment by PET scan imaging after one cycle of Pembrolizumab</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>24 months</time_frame>
    <description>Time between inclusion and progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>24 months</time_frame>
    <description>Time between inclusion and death</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>PET scan imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PET scan will be performed each of three first cycles of pembrolizumab to describe the early tumour metabolic changes during the first line of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET scan imaging</intervention_name>
    <description>3 PET scans will be performed after each 3 first infusions of Pembrolizumab</description>
    <arm_group_label>PET scan imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non operable non small cell lung cancer&#xD;
&#xD;
          -  Indication of treatment by Pembrolizumab&#xD;
&#xD;
          -  PD-L1 status superior to 50 %&#xD;
&#xD;
          -  Age more than 18 years&#xD;
&#xD;
          -  At least one measurable target&#xD;
&#xD;
          -  Written inform consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no treatment by pembrolizumab&#xD;
&#xD;
          -  immunosuppressive treatment&#xD;
&#xD;
          -  uncontrolled diabete&#xD;
&#xD;
          -  Pregnancy or breast-feeding&#xD;
&#xD;
          -  curatorship or guardianship&#xD;
&#xD;
          -  not possibility to follow-up the procedures of the study due to geographic, social or&#xD;
             psychic reasons&#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>Stephanie Becker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Henri Becquerel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Florian Guisier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Rouen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephanie Becker, MD</last_name>
    <phone>+33232888247</phone>
    <email>stephanie.becker@chb.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Doriane Richard, PhD</last_name>
    <phone>+33232082985</phone>
    <email>doriane.richard@chb.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie Becker, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luc Thiberville, Md, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PET scan imaging</keyword>
  <keyword>Pembrolizumab</keyword>
  <keyword>Response</keyword>
  <keyword>Parametric imaging</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>
  <!-- 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/NCT03832348
org study id: CHB18.05
nct id: NCT03832348
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell
      lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not
      they differ according to treatment response at 3 months.
Immunotherapy with anti-PD1 antibody, such as Pembrolizumab, is widely used in the treatment
      of stage III/IV non small cell lung cancer. In order to refine treatments and patients'
      prognosis, early assessment of tumour response is needed.

      The aim of this study is to describe the early tumour metabolic changes in non smal cell lung
      cancer during first line treatment with pembrolizumab, and to evaluate whether or not they
      differ according to treatment response.

      Eligible patients with stage III/IV, PDL1>50% NSCLC will receive pembrolizumab treatment as
      per standard of care.

      Tumour metabolism will be assessed by 18-FDG PETscan before each of the 3 first pembrolizumab
      infusions. Treatment response will be determined by RECIST, irRC and mCHOI criteria at 3
      months.

      Prognostic and predictive value of baseline and dynamic metabolic parameters will be
      assessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Determination of progression by early PET scan
time frame: 3 months
description: Determination of non-response of treatment by PET scan imaging after one cycle of Pembrolizumab
measure: Progression free survival
time frame: 24 months
description: Time between inclusion and progression
measure: Overall survival
time frame: 24 months
description: Time between inclusion and death
arm group label: PET scan imaging
arm group type: Experimental
description: PET scan will be performed each of three first cycles of pembrolizumab to describe the early tumour metabolic changes during the first line of treatment.
intervention type: Device
intervention name: PET scan imaging
description: 3 PET scans will be performed after each 3 first infusions of Pembrolizumab
arm group label: PET scan imaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephanie Becker, MD
role: Principal Investigator
affiliation: Centre Henri Becquerel
last name: Florian Guisier, MD
role: Principal Investigator
affiliation: CHU Rouen
last name: Stephanie Becker, MD
phone: +33232888247
email: stephanie.becker@chb.unicancer.fr
last name: Doriane Richard, PhD
phone: +33232082985
email: doriane.richard@chb.unicancer.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung