<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/NCT03827070</url>
  </required_header>
  <id_info>
    <org_study_id>9TJJ425H1D</org_study_id>
    <nct_id>NCT03827070</nct_id>
  </id_info>
  <brief_title>Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma</brief_title>
  <acronym>DPTA</acronym>
  <official_title>New Method of Treatment for Thoracoscopy or Bronchoscopy by Suspension of Fine Powder of Talcum and Afatinib is Used in Patients With Positive Mutation of EGFR in Non-Small Cell Lung Carcinoma (NSCLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center Trials &amp; Treatment Europe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Center Trials &amp; Treatment</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Center Trials &amp; Treatment Europe</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In non-small cell lung cancer and metastases in the pleural cavity, pathological effusion is&#xD;
      formed.&#xD;
&#xD;
      Currently, the most common and effective method of obliteration of the pleural cavity is&#xD;
      pleurodesis with talcum powder.&#xD;
&#xD;
      Talc, when it surface of the pleura, causes chemical inflammation that leads to the soldering&#xD;
      of the lungs and chest wall. As a result, the liquid ceases to accumulate.&#xD;
&#xD;
      The addition of a therapeutic dose of afatinib to talc not only blocks effusion into the&#xD;
      pleural cavity, but also reduces tumor and metastatic processes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed procedure for dry pleurodesis consists of one stage.&#xD;
&#xD;
      Talc is introduced into the pleural cavity in several ways:&#xD;
&#xD;
        -  Drainage - a tube is inserted into the pleural cavity through a puncture in the chest,&#xD;
           and then a pasty talcum is delivered into the cavity, which spreads through the cavity&#xD;
           during the change of the patient's body position.&#xD;
&#xD;
        -  Talcum powder - under the control of thoracoscopy, dry talc is blown into the pleural&#xD;
           cavity of the patient, which allows him to evenly distribute and significantly increases&#xD;
           the effectiveness of the procedure.&#xD;
&#xD;
      In this Clinical Trial investigators will use the method of thoracoscopy - the blow in of&#xD;
      talcum powder and therapeutic dose of Afatinib. Before injection, a suspension of talc and&#xD;
      afatinib is subjected to the procedure of pharmaceutical mixing.&#xD;
&#xD;
      The operation is well tolerated by participants and lasts no more than 30 minutes. The&#xD;
      effectiveness of the method is 90%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Anticipated">July 21, 2023</completion_date>
  <primary_completion_date type="Actual">February 21, 2023</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>Single Group Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>None (Open Label)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The effectiveness of the procedure of dry pleurodesis through a thoracoscope</measure>
    <time_frame>up to 90 days</time_frame>
    <description>Evaluation of the effectiveness of the dry pleurodesis procedure in combination with talc and afatinib with the introduction of a powder suspension through a thoracoscope.&#xD;
The assessment is performed by CT (computed tomography) of each participant twice: 30 days from the day of the procedure and 90 days later.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Talcum powder &amp; Afatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Talcum powder 4 g + Afatinib 0,4 g. Is entered once</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Afatinib</intervention_name>
    <description>Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (&lt;5 μm) - only 19%</description>
    <arm_group_label>Talcum powder &amp; Afatinib</arm_group_label>
    <other_name>BIBW2992</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Talcum powder</intervention_name>
    <description>Used Talcum powder particles of which had an average size of 24.5 μm and a volume concentration of small particles (&lt;5 μm) - only 11%</description>
    <arm_group_label>Talcum powder &amp; Afatinib</arm_group_label>
    <other_name>Talc</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-small cell lung cancer with positive mutation of EGFR verified&#xD;
&#xD;
          -  Malignant pleural effusion&#xD;
&#xD;
          -  Recurrent pleural effusion&#xD;
&#xD;
          -  Complete lung expansion (&gt; 80%) after puncture emptying confirmed by chest&#xD;
             radiography.&#xD;
&#xD;
          -  Karnofsky index &gt; 50&#xD;
&#xD;
          -  Agreed to participate in the study and sign an Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Radiotherapy not earlier than 3 months before the pleurodesis procedure&#xD;
&#xD;
          -  Previous surgeries on the same hemitorace&#xD;
&#xD;
          -  Thrombocytopenia or coagulation disorders&#xD;
&#xD;
          -  Trapped lung syndrome&#xD;
&#xD;
          -  Patients with estimated life expectancy &lt; 4-8 weeks&#xD;
&#xD;
          -  Pleural or active systemic infection&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Central Contact</name>
      <address>
        <city>Tbilisi</city>
        <zip>0008</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Georgia</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>April 23, 2023</last_update_submitted>
  <last_update_submitted_qc>April 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Afatinib</keyword>
  <keyword>Talcum powder</keyword>
  <keyword>Thoracoscopy</keyword>
  <keyword>Pleurodesis</keyword>
  <keyword>BIBW2992</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Afatinib</mesh_term>
  </intervention_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/NCT03827070
org study id: 9TJJ425H1D
nct id: NCT03827070
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In non-small cell lung cancer and metastases in the pleural cavity, pathological effusion is
      formed.

      Currently, the most common and effective method of obliteration of the pleural cavity is
      pleurodesis with talcum powder.

      Talc, when it surface of the pleura, causes chemical inflammation that leads to the soldering
      of the lungs and chest wall. As a result, the liquid ceases to accumulate.

      The addition of a therapeutic dose of afatinib to talc not only blocks effusion into the
      pleural cavity, but also reduces tumor and metastatic processes.
The proposed procedure for dry pleurodesis consists of one stage.

      Talc is introduced into the pleural cavity in several ways:

        -  Drainage - a tube is inserted into the pleural cavity through a puncture in the chest,
           and then a pasty talcum is delivered into the cavity, which spreads through the cavity
           during the change of the patient's body position.

        -  Talcum powder - under the control of thoracoscopy, dry talc is blown into the pleural
           cavity of the patient, which allows him to evenly distribute and significantly increases
           the effectiveness of the procedure.

      In this Clinical Trial investigators will use the method of thoracoscopy - the blow in of
      talcum powder and therapeutic dose of Afatinib. Before injection, a suspension of talc and
      afatinib is subjected to the procedure of pharmaceutical mixing.

      The operation is well tolerated by participants and lasts no more than 30 minutes. The
      effectiveness of the method is 90%.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: None (Open Label)
measure: The effectiveness of the procedure of dry pleurodesis through a thoracoscope
time frame: up to 90 days
description: Evaluation of the effectiveness of the dry pleurodesis procedure in combination with talc and afatinib with the introduction of a powder suspension through a thoracoscope.
The assessment is performed by CT (computed tomography) of each participant twice: 30 days from the day of the procedure and 90 days later.
arm group label: Talcum powder & Afatinib
arm group type: Experimental
description: Talcum powder 4 g + Afatinib 0,4 g. Is entered once
intervention type: Drug
intervention name: Afatinib
description: Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (<5 μm) - only 19%
arm group label: Talcum powder & Afatinib
other name: BIBW2992
intervention type: Drug
intervention name: Talcum powder
description: Used Talcum powder particles of which had an average size of 24.5 μm and a volume concentration of small particles (<5 μm) - only 11%
arm group label: Talcum powder & Afatinib
other name: Talc
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Georgia
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Lung Neoplasms
mesh term: Afatinib