<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/NCT03022500</url>
  </required_header>
  <id_info>
    <org_study_id>PSC</org_study_id>
    <nct_id>NCT03022500</nct_id>
  </id_info>
  <brief_title>Pulmonary sarcomatoid_MEDI4736+Treme</brief_title>
  <official_title>Phase II Study of Durvalumab + Tremelimumab in Pulmonary Sarcomatoid Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      To understand efficacy of Durvalumab(MEDI4736)+ Tremelimumab in Metastatic/relapsed pulmonary&#xD;
      sarcomatoid carcinoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase II multi-center, open-label study to evaluate efficacy and safety of&#xD;
      durvalumab + tremelimumab combination treatment in patients with pulmonary sarcomatoid&#xD;
      carcinoma&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 18, 2017</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <phase>Phase 2</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>Response rate (RR)</measure>
    <time_frame>24month</time_frame>
    <description>modified RECIST1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>24month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>24month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity</measure>
    <time_frame>24month</time_frame>
    <description>number of patients with treatment-related AE as assessed by NCI CTCAE version 4.0</description>
  </secondary_outcome>
  <other_outcome>
    <measure>biomarker</measure>
    <time_frame>24month</time_frame>
    <description>TGS(NGS)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Durvalumab + Tremelimumab Combination Treatment, Pulmonary Sarcomatoid Carcinoma, NSCLC</condition>
  <arm_group>
    <arm_group_label>durvalumab + tremelimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>durvalumab + tremelimumab</intervention_name>
    <description>Durvalumab: 1.5g Q4W plus Tremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.</description>
    <arm_group_label>durvalumab + tremelimumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 20 years&#xD;
&#xD;
          2. ECOG PS ≤1&#xD;
&#xD;
          3. Patients with histologically confirmed NSCLC with the histology of sarcomatoid&#xD;
             carcinoma (WHO criteria for sarcomatoid carcinoma is used; Carcinoma with spindle&#xD;
             and/or giant cells, Pleomorphic carcinoma, Spindle cell carcinoma, Giant cell&#xD;
             carcinoma, Carcinosarcoma, pulmonary blastoma. If the NSCLC patients showed&#xD;
             sarcomatoid carcinoma histology in re-biopsy sample(so called epithelial-mesenchymal&#xD;
             transition (EMT) phenomenon),the patients are eligible)&#xD;
&#xD;
          4. Initial metastatic cases or recurrent cases after curative treatment (any chemotherapy&#xD;
             line is allowed)&#xD;
&#xD;
          5. A patient with at least one measurable lesion of which the diameter is confirmed to be&#xD;
             ≥ 10mm in spiral CT or multi-detector CT (MD CT), or ≥ 20 mm in conventional CT (it&#xD;
             should be used by a consistent method during the study period).&#xD;
&#xD;
          6. If patients have brain metastasis with neurological symptom, they should be stabilized&#xD;
             neurologically with prior radiotherapy or surgery for the brain metastasis (no&#xD;
             neurologic symptom in progress and without further steroid treatment)&#xD;
&#xD;
          7. Adequate hematologic (neutrophil count ≥ 1,500 cells/mm3, platelets ≥ 100,000&#xD;
             cells/mm3), hepatic (transaminase ≤ upper normal limit(UNL)x2.5, bilirubin level ≤&#xD;
             UNLx1.5), and renal (creatinine ≤ UNL) function&#xD;
&#xD;
          8. A patient with the willingness to comply with the study protocol during the study&#xD;
             period and capable of complying with it.&#xD;
&#xD;
          9. A patient who signed the informed consent prior to the participation of the study and&#xD;
             who understands that he/she has a right to withdrawal from participation in the study&#xD;
             at any time without any disadvantages - Absolute neutrophil count 1,500 cells/mm3,&#xD;
             platelets 100,000 cells/mm3&#xD;
&#xD;
         10. Expected survival ≥ 3 months&#xD;
&#xD;
         11. Female subjects must either be of non-reproductive potential (ie, post-menopausal by&#xD;
             history: ≥60 years old and no menses for ≥1 year without an alternative medical cause;&#xD;
             or history of hysterectomy, or history of bilateral tubal ligation, or history of&#xD;
             bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A patient with no measurable disease&#xD;
&#xD;
          2. chronic systemic steroid therapy or on any other form of immunosuppressive medication&#xD;
&#xD;
          3. has received a live-virus vaccination within 30 days of planned treatment start&#xD;
&#xD;
          4. history of diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction,&#xD;
             abdominal carcinomatosis which are known risks factors for bowel perforation&#xD;
&#xD;
          5. active symptomatic central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis&#xD;
&#xD;
          6. severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)&#xD;
&#xD;
          7. active autoimmune disease within the past 2 years (NOTE: Subjects with vitiligo,&#xD;
             Grave's disease, or psoriasis not requiring systemic treatment -within the past 2&#xD;
             years- are not excluded) or a documented history of autoimmune disease or syndrome&#xD;
             that requires systemic steroids or immunosuppressive agents&#xD;
&#xD;
          8. prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD&#xD;
             Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or anti CTLA4 agents (including&#xD;
             durvalumab and tremelimumab)&#xD;
&#xD;
          9. active infection requiring therapy&#xD;
&#xD;
         10. history of Human Immunodeficiency Virus (HIV)&#xD;
&#xD;
         11. active Hepatitis B or C (inactive healthy carriers of HBV with appropriate&#xD;
             prophylactic antiviral agents are allowed)&#xD;
&#xD;
         12. symptomatic ascites or pleural effusion&#xD;
&#xD;
         13. pneumonitis that has required a course of oral steroids to assist with recovery, or a&#xD;
             history of interstitial lung disease&#xD;
&#xD;
         14. pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the study&#xD;
&#xD;
         15. History of active tuberculosis&#xD;
&#xD;
         16. History of allogeneic organ transplant. Current or prior use of immunosuppressive&#xD;
             medication within 28 days before the first dose of durvalumab or tremelimumab, with&#xD;
             the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids&#xD;
             at physiological doses, which are not to exceed 10 mg/day of prednisone, or an&#xD;
             equivalent corticosteroid&#xD;
&#xD;
         17. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy,&#xD;
             endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal&#xD;
             antibodies, other investigational agent) ≤ 21 days prior to the first dose of study&#xD;
             drug&#xD;
&#xD;
         18. History of allogeneic organ transplant&#xD;
&#xD;
         19. Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable&#xD;
             angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active&#xD;
             bleeding diatheses including any subject known to have evidence of acute or chronic&#xD;
             hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements or&#xD;
             compromise the ability of the subject to give written informed consent&#xD;
&#xD;
         20. Female patients who are pregnant or breastfeeding or male or female patients of&#xD;
             reproductive potential who are not willing to employ effective birth control from&#xD;
             screening to 180 days after the last dose of durvalumab + tremelimumab combination&#xD;
             therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the&#xD;
             longer time period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bhumsuk Kim, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Internal Medicine, Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>June 5, 2018</last_update_submitted>
  <last_update_submitted_qc>June 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Bhumsuk Keam</investigator_full_name>
    <investigator_title>Clinical Assistant Professo</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Durvalumab</mesh_term>
    <mesh_term>Tremelimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>anticipated as research paper</ipd_description>
  </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/NCT03022500
org study id: PSC
nct id: NCT03022500
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To understand efficacy of Durvalumab(MEDI4736)+ Tremelimumab in Metastatic/relapsed pulmonary
      sarcomatoid carcinoma
This is a phase II multi-center, open-label study to evaluate efficacy and safety of
      durvalumab + tremelimumab combination treatment in patients with pulmonary sarcomatoid
      carcinoma
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response rate (RR)
time frame: 24month
description: modified RECIST1.1
measure: Progression-Free Survival (PFS)
time frame: 24month
measure: Overall Survival (OS)
time frame: 24month
measure: Toxicity
time frame: 24month
description: number of patients with treatment-related AE as assessed by NCI CTCAE version 4.0
measure: biomarker
time frame: 24month
description: TGS(NGS)
arm group label: durvalumab + tremelimumab
arm group type: Experimental
description: Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.
intervention type: Drug
intervention name: durvalumab + tremelimumab
description: Durvalumab: 1.5g Q4W plus Tremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.
arm group label: durvalumab + tremelimumab
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Bhumsuk Kim, Ph.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Bhumsuk Keam
investigator title: Clinical Assistant Professo
mesh term: Carcinoma
mesh term: Durvalumab
mesh term: Tremelimumab
sharing ipd: Undecided
ipd description: anticipated as research paper