xml: <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/NCT05987345</url>
    </required_header>
    <id_info>
      <org_study_id>LCFIM-001</org_study_id>
      <nct_id>NCT05987345</nct_id>
    </id_info>
    <brief_title>Trial of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer</brief_title>
    <official_title>Safety and Clinical Efficacy Evaluation of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Energenx Medical LTD.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Energenx Medical LTD.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to verify the safety and clinical benefit of pulsed&#xD;
        electric field(PEF) treatment of metastatic non-small cell lung cancer(NSCLC) patients with&#xD;
        acquired resistance to anti programmed cell death protein 1(PD-1) monoclonal antibody&#xD;
        therapy. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Safety of PEF treatment of metastatic NSCLC patients.&#xD;
  &#xD;
          -  Control of ablated and other targeted lesions.&#xD;
  &#xD;
          -  Local and peripheral immunoregulation effect. PEF energy will be delivered to&#xD;
             preselected lesions of participants, then anti PD-1 will be routinely administrated if&#xD;
             no adverse event(AE)/serious adverse event(SAE) which need medical intervention occurs.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 6, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Technical success rate of PEF treatment</measure>
      <time_frame>7 days</time_frame>
      <description>The percentage of the number that the equipment successfully reached the target lesion and completed PEF energy delivery.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of PEF treatment related AE/SAEs</measure>
      <time_frame>1 month</time_frame>
      <description>The incidence and severity of PEF treatment related adverse events according to CTCAE version 4.0</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Local control of ablated lesions by CT</measure>
      <time_frame>3 months</time_frame>
      <description>Compared with the baseline CT scan before treatment, the maximum diameter of the ablated lesion decreased, remained unchanged or increased by less than 20%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Local control of ablated lesions by CT</measure>
      <time_frame>6 months</time_frame>
      <description>Compared with the baseline CT scan before treatment, the maximum diameter of the ablated lesion decreased, remained unchanged or increased by less than 20%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival rate at 6 months</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival rate at 6 months</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival rate at 12 months</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>NSCLC</condition>
    <arm_group>
      <arm_group_label>PEF treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All of participants who signed the Informed Consent Form(ICF) and meet all of inclusion and exclusion criterial will be enrolled to experimental arm. PEF treatment on Day 1, followed by anti PD-1 on Day 7 and then routinely.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PEF</intervention_name>
      <description>PEF device treated in the trial.</description>
      <arm_group_label>PEF treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Anti-PD-1 monoclonal antibody</intervention_name>
      <description>Anti-PD-1 monoclonal antibody administered on Day 7 then routinely.</description>
      <arm_group_label>PEF treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients over 18 years old with pathologically confirmed non-small cell lung cancer.&#xD;
  &#xD;
            2. Patients got benefit from anti PD-1 immunotherapy prior to disease progression.&#xD;
  &#xD;
            3. Lesions to be ablated must be ≤ 3cm in longest diameter.&#xD;
  &#xD;
            4. More than one measurable lesion according to RECIST 1.1 except PEF targeted lesions.&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group(ECOG) performance status 0-1&#xD;
  &#xD;
            6. Life expectancy ≥3 months&#xD;
  &#xD;
            7. Fully understand the treatment plan and sign the informed consent form voluntarily.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients should be excluded if they received surgery within 30 days.&#xD;
  &#xD;
            2. Patients should be excluded if they received any form of local treatment within 30&#xD;
               days.&#xD;
  &#xD;
            3. Accompanied by uncontrolled metastasis of the central nervous system.&#xD;
  &#xD;
            4. Have a history of severe adverse reactions to ICI.&#xD;
  &#xD;
            5. With uncontrolled immune system diseases or being treated with immunosuppressants.&#xD;
  &#xD;
            6. Severe abnormality of liver and kidney function, which was evaluated by the&#xD;
               researchers as unsuitable for admission.&#xD;
  &#xD;
            7. Patients with abnormal blood coagulation and antiplatelet therapy due to&#xD;
               cardiovascular and cerebrovascular diseases should be discontinued one week before PEF&#xD;
               treatment according to the evaluation of clinicians.&#xD;
  &#xD;
            8. Accompanied by infectious diseases that cannot be effectively controlled.&#xD;
  &#xD;
            9. Suffered from other severe lung diseases (including interstitial pneumonia, pulmonary&#xD;
               fibrosis, pulmonary fibrosis with emphysema, atelectasis, etc.)&#xD;
  &#xD;
           10. Patients who had severe cardiac dysfunction and had a history of arrhythmias in the&#xD;
               past 2 years, including rapid atrial arrhythmias, any rapid ventricular arrhythmias, a&#xD;
               history of degree II or III atrioventricular block, and sinus bradycardia with a heart&#xD;
               rate of less than 45 beats per minute.&#xD;
  &#xD;
           11. Patients who are participating in other clinical trials.&#xD;
  &#xD;
           12. With a cardiac pacemaker or metal implant in the chest.&#xD;
  &#xD;
           13. Women who are pregnant or lactating, or who plan to become pregnant during the study.&#xD;
  &#xD;
           14. The researchers determined that there were other conditions in which patients were not&#xD;
               suitable for enrollment.&#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>Shiyue Li, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The first Affiliated Hospital of Guanzhou Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jiajie Zhang, MD</last_name>
      <phone>+86 18621207399</phone>
      <email>jj.zhang@energenxmedical.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The first Affiliated Hospital of Guangzhou Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Li Shiyue, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>NSCLC</keyword>
    <keyword>PEF</keyword>
    <keyword>Immune Checkpoint Inhibitor(ICI)</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies</mesh_term>
      <mesh_term>Antibodies, Monoclonal</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05987345
  org study id: LCFIM-001
  nct id: NCT05987345
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to verify the safety and clinical benefit of pulsed
        electric field(PEF) treatment of metastatic non-small cell lung cancer(NSCLC) patients with
        acquired resistance to anti programmed cell death protein 1(PD-1) monoclonal antibody
        therapy. The main questions it aims to answer are:
  
          -  Safety of PEF treatment of metastatic NSCLC patients.
  
          -  Control of ablated and other targeted lesions.
  
          -  Local and peripheral immunoregulation effect. PEF energy will be delivered to
             preselected lesions of participants, then anti PD-1 will be routinely administrated if
             no adverse event(AE)/serious adverse event(SAE) which need medical intervention occurs.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Technical success rate of PEF treatment
  time frame: 7 days
  description: The percentage of the number that the equipment successfully reached the target lesion and completed PEF energy delivery.
  measure: Incidence of PEF treatment related AE/SAEs
  time frame: 1 month
  description: The incidence and severity of PEF treatment related adverse events according to CTCAE version 4.0
  measure: Local control of ablated lesions by CT
  time frame: 3 months
  description: Compared with the baseline CT scan before treatment, the maximum diameter of the ablated lesion decreased, remained unchanged or increased by less than 20%.
  measure: Local control of ablated lesions by CT
  time frame: 6 months
  description: Compared with the baseline CT scan before treatment, the maximum diameter of the ablated lesion decreased, remained unchanged or increased by less than 20%.
  measure: Progression free survival rate at 6 months
  time frame: 6 months
  measure: Overall survival rate at 6 months
  time frame: 6 months
  measure: Overall survival rate at 12 months
  time frame: 12 months
  arm group label: PEF treatment
  arm group type: Experimental
  description: All of participants who signed the Informed Consent Form(ICF) and meet all of inclusion and exclusion criterial will be enrolled to experimental arm. PEF treatment on Day 1, followed by anti PD-1 on Day 7 and then routinely.
  intervention type: Device
  intervention name: PEF
  description: PEF device treated in the trial.
  arm group label: PEF treatment
  intervention type: Drug
  intervention name: Anti-PD-1 monoclonal antibody
  description: Anti-PD-1 monoclonal antibody administered on Day 7 then routinely.
  arm group label: PEF treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shiyue Li, MD
  role: Principal Investigator
  affiliation: The first Affiliated Hospital of Guanzhou Medical University
  last name: Jiajie Zhang, MD
  phone: +86 18621207399
  email: jj.zhang@energenxmedical.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Antibodies
  mesh term: Antibodies, Monoclonal