<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/NCT04427475</url>
  </required_header>
  <id_info>
    <org_study_id>MIRNA-SEP-01</org_study_id>
    <nct_id>NCT04427475</nct_id>
  </id_info>
  <brief_title>Prediction of Immunotherapeutic Effect of Advanced Non-small Cell Lung Cancer</brief_title>
  <official_title>Study on the Prediction of Immunotherapeutic Effect of Advanced Non-small Cell Lung Cancer by Detection of Plasma Exosomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</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>
      To detect the difference of PD-L1 and miRNA expression profiles of exosomes in NSCLC patients&#xD;
      before and after immunotherapy, and to explore the potential of plasma exosomes PD-L1 and&#xD;
      miRNAs as biomarkers to predict the therapeutic effect of NSCLC on anti-PD-1 / PD-L1.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PD-L1 expression profiles of exosomes</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>detect the difference of PD-L1 expression profiles of exosomes in NSCLC patients before and after immunotherapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>miRNA expression profiles of exosomes</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>detect the difference of miRNA expression profiles of exosomes in NSCLC patients before and after immunotherapy</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>NSCLC Patients</condition>
  <arm_group>
    <arm_group_label>pabolizumab</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nafulizumab</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pabolizumab</intervention_name>
    <description>100 patients with stage IV EGFR / ALK wild-type NSCLC (squamous cell carcinoma patients do not need to be detected) who received anti-PD-1 (pabolizumab) treatment combined with chemotherapy as the first-line treatment were enrolled in the center. Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles. At the same time, plasma samples were collected at key nodes until the patient's progress.</description>
    <arm_group_label>pabolizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nafulizumab</intervention_name>
    <description>nafulizumab</description>
    <arm_group_label>nafulizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sign informed consent.&#xD;
&#xD;
          2. The age is greater than or equal to 18 years old.&#xD;
&#xD;
          3. There is at least one measurable focus according to the RECIST 1.1 standard&#xD;
&#xD;
          4. EGFR / ALK detection is not needed in patients with metastatic (stage IV) EGFR / ALK&#xD;
             wild-type NSCLC confirmed by histology or cytology and in patients with squamous cell&#xD;
             carcinoma.&#xD;
&#xD;
          5. Cohort 1: patients receiving anti-PD-1 (pabolizumab) treatment combined with&#xD;
             chemotherapy as the first-line treatment Cohort 2: patients who received the&#xD;
             second-line treatment of anti-PD-1 single drug (nafulizumab) for the progress of&#xD;
             disease after chemotherapy with platinum containing dual drugs&#xD;
&#xD;
          6. ECoG score is 0, 1 or 2.&#xD;
&#xD;
          7. No serious blood system, heart, lung, liver and kidney dysfunction and immune&#xD;
             deficiency.&#xD;
&#xD;
          8. Hemoglobin (HB) ≥ 9g / dl; leukocyte (WBC) ≥ 3 * 109 / L; neutrophil (ANC) ≥ 1.5 * 109&#xD;
             / L; platelet (PLT) ≥ 75 * 109 / L.&#xD;
&#xD;
          9. Men or women of childbearing age are willing to take contraceptive measures in the&#xD;
             experiment.&#xD;
&#xD;
         10. Estimated survival time ≥ 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Histologically, small cell and non-small cell mixed lung cancer.&#xD;
&#xD;
          2. Pregnant or nursing women.&#xD;
&#xD;
          3. Any unresponsive &gt; CTCAE Level 2 toxicity caused by past anti-tumor treatment&#xD;
&#xD;
          4. Serum creatinine clearance &lt; 30 ml / min (calculated by Cockcroft Gault formula)&#xD;
&#xD;
          5. Liver dysfunction, defined as:&#xD;
&#xD;
               1. Serum (total) bilirubin &gt; 1.5 × upper limit of normal value (ULN)&#xD;
&#xD;
               2. Serum AST / SGOT or ALT / SGPT &gt; 2.5 × ULN (liver metastasis &gt; 5 × ULN)&#xD;
&#xD;
               3. Alkaline phosphatase level &gt; 2.5 × ULN (liver metastasis &gt; 5 × ULN, or bone) at&#xD;
                  baseline Transfer patients &gt; 10 × ULN)&#xD;
&#xD;
          6. Have a history of uncontrollable or symptomatic angina, arrhythmia or congestive heart&#xD;
             failure.&#xD;
&#xD;
          7. Symptomatic brain metastasis or meningeal metastasis.&#xD;
&#xD;
          8. In the past 5 years, she has had or is suffering from other histological types of&#xD;
             malignant tumors, except for cervical carcinoma in situ and fully treated skin basal&#xD;
             cell carcinoma or squamous cell carcinoma.&#xD;
&#xD;
          9. Have active, or have had and may recur autoimmune diseases. However, subjects with&#xD;
             type I diabetes, hypothyroidism requiring hormone replacement therapy only, skin&#xD;
             diseases without systemic treatment (such as vitiligo, psoriasis or alopecia), or no&#xD;
             relapse without external triggers are expected.&#xD;
&#xD;
         10. Diagnosis of immunodeficiency or systemic hormone therapy (e.g., hormone therapy&#xD;
             equivalent to &gt; 10 mg prednisone per day) or any other form of immunosuppressive&#xD;
             therapy within 7 days before the first administration.&#xD;
&#xD;
         11. Patients with known history of human immunodeficiency virus (HIV) infection and / or&#xD;
             acquired immunodeficiency syndrome. Subjects with active hepatitis B or active&#xD;
             hepatitis C&#xD;
&#xD;
         12. Grade 2 pneumonia caused by radiotherapy and chemotherapy (grade 2 pneumonia without&#xD;
             systemic hormone treatment recovers to grade 1 or below within 14 days, if the&#xD;
             researcher judges that there is no risk of recurrence, it can be included in the group&#xD;
             for screening).&#xD;
&#xD;
         13. Have interstitial lung disease and the disease has symptoms.&#xD;
&#xD;
         14. During the study period, radiotherapy is planned for the target focus.&#xD;
&#xD;
         15. Plan to use other anti-tumor therapy during the study period.&#xD;
&#xD;
         16. Patients with serious or uncontrolled systemic diseases who are not suitable for the&#xD;
             study or may affect the compliance of the other party's case. Subjects' complications&#xD;
             or other conditions may affect compliance with the protocol or may not be suitable for&#xD;
             the study.&#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_contact>
    <last_name>wang jia lei, doctor</last_name>
    <phone>18017312369</phone>
    <email>haitunqiao@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>wang jia lei, DOCTOR</last_name>
      <phone>18017312369</phone>
      <email>haitunqiao@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Jialei Wang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>
  <!-- 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/NCT04427475
org study id: MIRNA-SEP-01
nct id: NCT04427475
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To detect the difference of PD-L1 and miRNA expression profiles of exosomes in NSCLC patients
      before and after immunotherapy, and to explore the potential of plasma exosomes PD-L1 and
      miRNAs as biomarkers to predict the therapeutic effect of NSCLC on anti-PD-1 / PD-L1.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: PD-L1 expression profiles of exosomes
time frame: through study completion, an average of 1 year
description: detect the difference of PD-L1 expression profiles of exosomes in NSCLC patients before and after immunotherapy
measure: miRNA expression profiles of exosomes
time frame: through study completion, an average of 1 year
description: detect the difference of miRNA expression profiles of exosomes in NSCLC patients before and after immunotherapy
arm group label: pabolizumab
arm group type: Other
description: Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles.
arm group label: nafulizumab
arm group type: Other
description: Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles.
intervention type: Drug
intervention name: pabolizumab
description: 100 patients with stage IV EGFR / ALK wild-type NSCLC (squamous cell carcinoma patients do not need to be detected) who received anti-PD-1 (pabolizumab) treatment combined with chemotherapy as the first-line treatment were enrolled in the center. Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles. At the same time, plasma samples were collected at key nodes until the patient's progress.
arm group label: pabolizumab
intervention type: Drug
intervention name: nafulizumab
description: nafulizumab
arm group label: nafulizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: wang jia lei, doctor
phone: 18017312369
email: haitunqiao@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Jialei Wang
investigator title: Principal Investigator
mesh term: Carcinoma, Non-Small-Cell Lung