<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/NCT04465942</url>
  </required_header>
  <id_info>
    <org_study_id>01171</org_study_id>
    <nct_id>NCT04465942</nct_id>
  </id_info>
  <brief_title>Immunotherapy in Lung Cancer: Treatment After IO Cessation.</brief_title>
  <official_title>Immunotherapy in Lung Cancer: Which Treatment After Immunotherapy Cessation: A Prospective Registry From the European Lung Cancer Working Party</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Lung Cancer Working Party</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Lung Cancer Working Party</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>
      Immunotherapy is now a standard of care for first-line and eventually salvage therapy in&#xD;
      patients with stage IV NSCLC and as adjuvant after RT-CT for stage III NSCLC.&#xD;
&#xD;
      The aim of the study is determining the therapeutic landscape and the reason for&#xD;
      immunotherapy cessation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with stage IV or unresectable not irradiable stage III NSCLC will be registered at&#xD;
      the time receiving immunotherapy alone or in combination with chemotherapy.&#xD;
&#xD;
      When IO is stopped, reason for cessation and further treatment will be recorded.&#xD;
&#xD;
      Secondary endpoints are survival after IO cessation, activity of first salvage therapy,&#xD;
      disease-free survival after IO cessation in patients receiving no further treatment.&#xD;
&#xD;
      Patients will be centrally registered at the ELCWP headquarter (Institut Jules Bordet,&#xD;
      Brussels, Belgium).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>to determine the therapeutic landscape after cessation of an immune checkpoint therapy</measure>
    <time_frame>From IO cessation date up to first treatment whatever the time in-between and up to 5 years</time_frame>
    <description>Which treatment is proposed after IO cessation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>survival</measure>
    <time_frame>From IO cessation date up to death or up to 5 years</time_frame>
    <description>survival after ICI cessation, overall and in pre-defined subgroups (cessation for progressive disease [group 1], for toxicity [group 2], by patient decision without progression [group 3])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of salvage therapy - response</measure>
    <time_frame>At the end of cycle 2 or 3 (according to routine local practice), one cycle corresponding to 21 days, up to 6 cycles. assessment will done according to RECIST criteria</time_frame>
    <description>Best response to first salvage chemotherapy after ICI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>From IO cessation to progression documentation or death or up to 5 years</time_frame>
    <description>disease-free survival in untreated non-progressive patients after ICI cessation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>second-line ICI effectiveness - response</measure>
    <time_frame>From initiation of second-line IO up to 2 years</time_frame>
    <description>Response to second-line ICI (response rate) using WHO criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>second-line ICI effectiveness - progression-free survival</measure>
    <time_frame>From initation of second-line ICI up to progression or death and up to 5 years</time_frame>
    <description>PFS to second-line ICI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of salvage therapy - progression-free survival</measure>
    <time_frame>From initation of salvage therapy up to progression or death and up to 5 years</time_frame>
    <description>Progression-free survival to first salvage chemotherapy after ICI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of salvage therapy - survival</measure>
    <time_frame>From initation of second-line ICI up to death and up to 5 years</time_frame>
    <description>Survival to first salvage chemotherapy after ICI</description>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <condition>Immunotherapy</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>(chemo)immunotherapy</intervention_name>
    <description>Patients are receiving immunotherapy or chemoimmunotherapy as a standard of care</description>
    <other_name>cisplatinum</other_name>
    <other_name>carboplatinum</other_name>
    <other_name>pemetrexed</other_name>
    <other_name>paclitaxel</other_name>
    <other_name>pembrolizumab</other_name>
    <other_name>nivolumab</other_name>
    <other_name>atezolizumab</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Stage IV or unresectable and non irradiable NSCLC, naïve of immunotherapy and receiving&#xD;
        immunotherapy alone or combined chemo-immunotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological diagnosis of non-small cell lung cancer (NSCLC)&#xD;
&#xD;
          -  Stage IVA/IVB and unresectable and non irradiable stage III NSCLC naïve of&#xD;
             immunotherapy.&#xD;
&#xD;
          -  Patients who receive immunotherapy (any type) monotherapy, combined immunotherapy or&#xD;
             in combination with chemotherapy for first or second-line treatment.&#xD;
&#xD;
          -  Availability for participating in the detailed follow-up of the protocol.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving adjuvant immunotherapy for stage I-III NSCLC are not eligible&#xD;
&#xD;
          -  Tumours for which TNM stage at time of study inclusion cannot be assessed.&#xD;
&#xD;
          -  History of prior malignant tumour, except non-melanoma skin cancer or in situ&#xD;
             carcinoma of the cervix or of the bladder or cured malignant tumor (more than 5-year&#xD;
             disease free interval).&#xD;
&#xD;
          -  Any type of immunotherapy for previous cancer&#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>Thierry Berghmans, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>ELCWP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thierry Berghmans, MD, PhD</last_name>
    <phone>003225413191</phone>
    <email>thierry.berghmans@bordet.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bogdan Grigoriu, MD, PhD</last_name>
    <phone>003225413191</phone>
    <email>bogdan.grigoriu@bordet.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thierry Berghmans, MD, PhD</last_name>
      <phone>0032/2/5413191</phone>
    </contact>
    <investigator>
      <last_name>Thierry Berghmans, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Pneumology CHU Charleroi</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ionela Bold, MD</last_name>
    </contact>
    <investigator>
      <last_name>Ionela Bold, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Pneumology Hôpital Saint-Joseph</name>
      <address>
        <city>Gilly</city>
        <zip>6060</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Benoît Colinet, MD</last_name>
    </contact>
    <investigator>
      <last_name>Benoît Colinet, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Ambroise Paré</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Stéphane Holbrechts, MD</last_name>
    </contact>
    <investigator>
      <last_name>Patricia Wackenier, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stéphane Holbrechts, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Mont-Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sebahat Ocak, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Sebahat Ocak, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 20, 2021</last_update_submitted>
  <last_update_submitted_qc>August 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2021</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, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Atezolizumab</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/NCT04465942
org study id: 01171
nct id: NCT04465942
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Immunotherapy is now a standard of care for first-line and eventually salvage therapy in
      patients with stage IV NSCLC and as adjuvant after RT-CT for stage III NSCLC.

      The aim of the study is determining the therapeutic landscape and the reason for
      immunotherapy cessation.
Patients with stage IV or unresectable not irradiable stage III NSCLC will be registered at
      the time receiving immunotherapy alone or in combination with chemotherapy.

      When IO is stopped, reason for cessation and further treatment will be recorded.

      Secondary endpoints are survival after IO cessation, activity of first salvage therapy,
      disease-free survival after IO cessation in patients receiving no further treatment.

      Patients will be centrally registered at the ELCWP headquarter (Institut Jules Bordet,
      Brussels, Belgium).
observational model: Cohort
time perspective: Prospective
measure: to determine the therapeutic landscape after cessation of an immune checkpoint therapy
time frame: From IO cessation date up to first treatment whatever the time in-between and up to 5 years
description: Which treatment is proposed after IO cessation
measure: survival
time frame: From IO cessation date up to death or up to 5 years
description: survival after ICI cessation, overall and in pre-defined subgroups (cessation for progressive disease [group 1], for toxicity [group 2], by patient decision without progression [group 3])
measure: Activity of salvage therapy - response
time frame: At the end of cycle 2 or 3 (according to routine local practice), one cycle corresponding to 21 days, up to 6 cycles. assessment will done according to RECIST criteria
description: Best response to first salvage chemotherapy after ICI
measure: Disease-free survival
time frame: From IO cessation to progression documentation or death or up to 5 years
description: disease-free survival in untreated non-progressive patients after ICI cessation
measure: second-line ICI effectiveness - response
time frame: From initiation of second-line IO up to 2 years
description: Response to second-line ICI (response rate) using WHO criteria
measure: second-line ICI effectiveness - progression-free survival
time frame: From initation of second-line ICI up to progression or death and up to 5 years
description: PFS to second-line ICI
measure: Activity of salvage therapy - progression-free survival
time frame: From initation of salvage therapy up to progression or death and up to 5 years
description: Progression-free survival to first salvage chemotherapy after ICI
measure: Activity of salvage therapy - survival
time frame: From initation of second-line ICI up to death and up to 5 years
description: Survival to first salvage chemotherapy after ICI
intervention type: Drug
intervention name: (chemo)immunotherapy
description: Patients are receiving immunotherapy or chemoimmunotherapy as a standard of care
other name: cisplatinum
other name: carboplatinum
other name: pemetrexed
other name: paclitaxel
other name: pembrolizumab
other name: nivolumab
other name: atezolizumab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thierry Berghmans, MD, PhD
role: Study Chair
affiliation: ELCWP
last name: Thierry Berghmans, MD, PhD
phone: 003225413191
email: thierry.berghmans@bordet.be
last name: Bogdan Grigoriu, MD, PhD
phone: 003225413191
email: bogdan.grigoriu@bordet.be
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: Belgium
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Pembrolizumab
mesh term: Nivolumab
mesh term: Pemetrexed
mesh term: Atezolizumab
sharing ipd: Undecided