<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/NCT04487093</url>
  </required_header>
  <id_info>
    <org_study_id>DYYY-2020-04-01</org_study_id>
    <nct_id>NCT04487093</nct_id>
  </id_info>
  <brief_title>Clinical Study of Neoantigen Vaccine Combined With Targeted Drugs in the Treatment of Non-small Cell Lung Cancer</brief_title>
  <official_title>Clinical Study of Personalized Neoantigen Peptide Vaccine Combined With Targeted Drugs in the Treatment of Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Hospital of Shijiazhuang City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tianjin Hengjia Biotechnology Development co., LTD</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>First Hospital of Shijiazhuang City</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>
      Neoantigen vaccine is a new field of research in tumor immunotherapy, and some studies have&#xD;
      been conducted with success on Melanoma and glioblastoma. Nearly 80% of lung cancers are&#xD;
      diagnosed in an advanced stage (IIIB, and IV) and EGFR mutant non-small cell lung cancer will&#xD;
      be resistant after targeted drug treatment. Neoantigen vaccine is a new treatment method for&#xD;
      lung cancer, especially for patients with drug resistance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase I clinical study of individualized neoantigen peptide vaccine combined with&#xD;
      targeted drugs in the treatment of EGFR mutant non-small cell lung cancer aimed to evaluated&#xD;
      the safety and immune response of the neoantigen vaccine treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 17, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 17, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients enrolled without disease progression were given neoantigen vaccine combined with EGFR-TKI therapy； Patients with disease progression were given neoantigen vaccine combined with anti-angiogenesis drug therapy. Patients received subcutaneous injection of individualized neoantigen vaccines at a dose of 200ug per peptide once a week for 5 weeks. The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.</measure>
    <time_frame>24 months</time_frame>
    <description>Safety</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>OS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate(DCR)</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>DCR as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>neoantigen vaccine + EGFR-TKI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>neoantigen vaccine + anti-angioge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>neoantigen vaccine + EGFR-TKI</intervention_name>
    <description>Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 5 weeks.&#xD;
The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance.</description>
    <arm_group_label>neoantigen vaccine + EGFR-TKI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>neoantigen vaccine + anti-angioge</intervention_name>
    <description>neoantigen vaccine + anti-angioge</description>
    <arm_group_label>neoantigen vaccine + anti-angioge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed locally advanced or metastatic non-small-cell lung cancer&#xD;
             (stage III or stage IV).&#xD;
&#xD;
          2. With EGFR-TKI sensitive mutations and no T790M.&#xD;
&#xD;
          3. First generation EGFR-TKI treatment is in progress, the treatment time is 5-6 months&#xD;
             and there is no disease progression.&#xD;
&#xD;
          4. Patients aged 18 to 85&#xD;
&#xD;
          5. Life expectancy of at least 3 months.&#xD;
&#xD;
          6. ECOG Performance Status 0 to 3.&#xD;
&#xD;
          7. No previous immunotherapy, including anti-PD-1/PD-L1 or co-suppressive T cell receptor&#xD;
             drug therapy, peptide / mRNA neoantigen immunotherapy and cell therapy.&#xD;
&#xD;
          8. Ability to follow research and follow-up procedures. Able to understand and willing to&#xD;
             sign an IRB approved written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant and/or breastfeeding.&#xD;
&#xD;
          2. With active, known or suspected autoimmune diseases or other concurrent immune system&#xD;
             diseases.&#xD;
&#xD;
          3. Receive systemic cytotoxic chemotherapy or experimental drugs within 4 weeks before&#xD;
             the start of neoantigen treatment, excluding EGFR-TKI and anti-angiogenesis targeted&#xD;
             drugs.&#xD;
&#xD;
          4. Patients participated in other anticancer drug clinical trials within 4 weeks.&#xD;
&#xD;
          5. Liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and&#xD;
             impaired hematopoietic function.&#xD;
&#xD;
          6. Systemic infection.&#xD;
&#xD;
          7. Any uncertainties that have an impact on the safety or compliance of the patient.&#xD;
&#xD;
          8. Any disease, treatment, abnormal laboratory history or medical history that affects&#xD;
             the participant's participation in the entire research process, or the investigator&#xD;
             believes that it is not suitable to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan Zhang, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The First Hospital of Shijiazhuang</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yan Zhang, M.D.</last_name>
    <phone>17603119607</phone>
    <email>13315978836@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Hospital of Shijiazhuang</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Zhang, M.D.</last_name>
      <phone>17603119607</phone>
      <phone_ext>+86</phone_ext>
      <email>13315978836@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Hospital of Shijiazhuang City</investigator_affiliation>
    <investigator_full_name>YAN ZHANG</investigator_full_name>
    <investigator_title>Director of Oncology IV</investigator_title>
  </responsible_party>
  <keyword>non-small cell lung cancer</keyword>
  <keyword>Individualized neoantigen peptides vaccine</keyword>
  <keyword>Targeted Drugs</keyword>
  <keyword>clinical trial</keyword>
  <keyword>phase I</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04487093
org study id: DYYY-2020-04-01
nct id: NCT04487093
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Neoantigen vaccine is a new field of research in tumor immunotherapy, and some studies have
      been conducted with success on Melanoma and glioblastoma. Nearly 80% of lung cancers are
      diagnosed in an advanced stage (IIIB, and IV) and EGFR mutant non-small cell lung cancer will
      be resistant after targeted drug treatment. Neoantigen vaccine is a new treatment method for
      lung cancer, especially for patients with drug resistance.
This is a phase I clinical study of individualized neoantigen peptide vaccine combined with
      targeted drugs in the treatment of EGFR mutant non-small cell lung cancer aimed to evaluated
      the safety and immune response of the neoantigen vaccine treatment.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Patients enrolled without disease progression were given neoantigen vaccine combined with EGFR-TKI therapy； Patients with disease progression were given neoantigen vaccine combined with anti-angiogenesis drug therapy. Patients received subcutaneous injection of individualized neoantigen vaccines at a dose of 200ug per peptide once a week for 5 weeks. The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance.
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
time frame: 24 months
description: Safety
measure: Progression-free Survival (PFS)
time frame: Up to 2 years
description: PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
measure: Overall survival (OS)
time frame: Up to 2 years
description: OS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
measure: Disease Control Rate(DCR)
time frame: Up to 12 weeks
description: DCR as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
arm group label: neoantigen vaccine + EGFR-TKI
arm group type: Experimental
arm group label: neoantigen vaccine + anti-angioge
arm group type: Experimental
intervention type: Drug
intervention name: neoantigen vaccine + EGFR-TKI
description: Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 5 weeks.
The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance.
arm group label: neoantigen vaccine + EGFR-TKI
intervention type: Drug
intervention name: neoantigen vaccine + anti-angioge
description: neoantigen vaccine + anti-angioge
arm group label: neoantigen vaccine + anti-angioge
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yan Zhang, M.D.
role: Study Chair
affiliation: The First Hospital of Shijiazhuang
last name: Yan Zhang, M.D.
phone: 17603119607
email: 13315978836@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Hospital of Shijiazhuang City
investigator full name: YAN ZHANG
investigator title: Director of Oncology IV
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Vaccines
sharing ipd: No