<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/NCT04467723</url>
  </required_header>
  <id_info>
    <org_study_id>IIT-2020-CAFs</org_study_id>
    <nct_id>NCT04467723</nct_id>
  </id_info>
  <brief_title>Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC</brief_title>
  <official_title>CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I/II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>parkview cancer institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if adding pirfenidone to atezolizumab will increase anti&#xD;
      tumor activity and reduce treatment resistance in stage 4 and recurrent non- small cell lung&#xD;
      cancer participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 18, 2022</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
  <phase>Phase 1/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>Occurrence of Grade 3 toxicity</measure>
    <time_frame>Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)</time_frame>
    <description>CTCAE v5.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of Grade 4 toxicity</measure>
    <time_frame>Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)</time_frame>
    <description>CTCAE v5.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR) of participants</measure>
    <time_frame>Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)</time_frame>
    <description>RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>From Cycle 1 day 1 (Each cycle is 21 days) for up to 2 years after end of treatment</time_frame>
    <description>RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-year overall survival (OS) rate: Proportion of participants alive at 1 year from Cycle 1 day 1</measure>
    <time_frame>Cycle 1 day 1 up to 1 year post-Cycle 1 day 1 (Each cycle is 21 days)</time_frame>
    <description>Medical records</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>NSCLC Stage IV</condition>
  <condition>NSCLC, Recurrent</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atezolizumab (Tecentriq) intravenous (IV) 1200mg flat dose day 1 then every 3 weeks.&#xD;
Pirfenidone (Esbriet) orally (PO) with food according to this schedule:&#xD;
Days 1-14: 267 milligrams (mg) orally three times per day (PO TID) Days 15-29: 534 mg PO TID Days 30 onward until progression: 801 mg PO TID</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab is given as an intravenous infusion at 1200 mg every 3 weeks. Pirfenidone is taken by mouth 3 times a day with the dose increasing every 2 week until day 30</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Pirfenidone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant or legal representative is able to provide written informed prior to&#xD;
             performing any protocol-related procedures&#xD;
&#xD;
          -  Is willing and able to comply with scheduled visits, treatment schedule, laboratory&#xD;
             testing and other requirements of the study&#xD;
&#xD;
          -  Men or women at least 18 years of age with histologically or cytologically confirmed&#xD;
             non-small cell lung cancer&#xD;
&#xD;
          -  Previous history of other than lung cancer is allowed if no active treatment for that&#xD;
             cancer within 1 year&#xD;
&#xD;
          -  Life expectancy of at least 6 months&#xD;
&#xD;
          -  De novo stage IV or recurrent NSCLC without actionable mutation (e.g. EGFR/ ALK/&#xD;
             ROS-1) that was previously treated with either PD-1 / PD-L1 or the combination of&#xD;
             PD1/PDL1 and cytotoxic chemotherapy, no more than 2 systemic regimens for metastatic&#xD;
             disease with measurable disease *. Maintenance therapy will be considered part of the&#xD;
             1 regimen&#xD;
&#xD;
          -  At least 1 measurable lesion&#xD;
&#xD;
          -  PDL1 TPS score less than 1% or unknown: first-line must be PD1/PDL1 inhibitor in&#xD;
             combination with chemotherapy&#xD;
&#xD;
          -  Early stage (I-III) NSCLC treated with adjuvant or neoadjuvant chemotherapy then&#xD;
             PD1/PDL1 inhibitor treatment for recurrent disease&#xD;
&#xD;
          -  Recurrent Unresectable stage III NSCLC treated with prior chemoradiation followed by&#xD;
             maintenance PD1/PDL1 inhibitor with measurable disease&#xD;
&#xD;
          -  Eastern Cooperative Group (ECOG) Performance Status 0 - 2&#xD;
&#xD;
          -  Is able to swallow oral medications&#xD;
&#xD;
          -  Adequate hematologic function&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of any other concurrent severe and/or uncontrolled medical condition that&#xD;
             would, in the investigator or treating physician's judgement, cause unacceptable&#xD;
             safety risks, contraindicate patient participation in the clinical study or compromise&#xD;
             compliance with the protocol&#xD;
&#xD;
          -  Has received investigational agents within 14 days or 5 half-lives of the compound or&#xD;
             active metabolites, whichever is longer, before the first dose of study treatment&#xD;
&#xD;
          -  Has a known hypersensitivity to atezolizumab or pirfenidone&#xD;
&#xD;
          -  Has active medical or psychiatric illness that would interfere with the study&#xD;
             treatment&#xD;
&#xD;
          -  Has uncontrolled diabetes&#xD;
&#xD;
          -  Has any of the following cardiac diagnoses:&#xD;
&#xD;
        Unstable angina Myocardial infarction within 6 months Uncontrolled congestive heart failure&#xD;
        Left ventricular ejection fraction &lt; 35%&#xD;
&#xD;
          -  Has a history of any Grade 3 or 4 toxicities to a prior checkpoint inhibitor treatment&#xD;
&#xD;
          -  Is pregnant or breast feeding&#xD;
&#xD;
          -  Uncontrolled HIV&#xD;
&#xD;
          -  Clinically diagnosed with grade 2 or 3 radiation-induced lung injury within the last 3&#xD;
             months prior to registering for the study&#xD;
&#xD;
          -  Has a history of idiopathic pneumonitis that required systemic agent including steroid&#xD;
&#xD;
          -  Has drug-induced pneumonitis&#xD;
&#xD;
          -  Has evidence of active pneumonitis on screening chest computed tomography (CT) scan&#xD;
&#xD;
          -  Smoker of more than 1 pack / day&#xD;
&#xD;
          -  Has active peptic ulcer diagnosed within 4 weeks of enrollment&#xD;
&#xD;
          -  Active infection requiring systemic treatment&#xD;
&#xD;
          -  Current use of systemic antibacterial or antifungal agent&#xD;
&#xD;
          -  Prior monoclonal antibody within 4 weeks before study Day 1 Exception: The use of&#xD;
             denosumab&#xD;
&#xD;
          -  Patient not recovered to ≤ Grade 1 from AEs due to agents administered more than 4&#xD;
             weeks earlier&#xD;
&#xD;
          -  Concurrent use of other investigational agents&#xD;
&#xD;
          -  Uncontrolled or symptomatic brain metastasis or leptomeningeal disease that requires&#xD;
             use of steroids&#xD;
&#xD;
          -  Use of strong CYP1A2 inhibitors&#xD;
&#xD;
          -  Previous history of cancer with active treatment within less than 1 year of enrollment&#xD;
&#xD;
          -  Active auto-immune diseases&#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>Chao Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Kansas</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>KUCC Navigator</last_name>
    <phone>9135883671</phone>
    <email>KUCC_Navigation@kumc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center (KUCC)</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>KUCC Navigator</last_name>
      <phone>913-588-3671</phone>
      <email>kucc_navigation@kumc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center, Westwood Campus</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>KUCC Navigation</last_name>
      <phone>913-588-3671</phone>
      <email>kucc_navigation@kumc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pirfenidone</mesh_term>
    <mesh_term>Atezolizumab</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/NCT04467723
org study id: IIT-2020-CAFs
nct id: NCT04467723
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to see if adding pirfenidone to atezolizumab will increase anti
      tumor activity and reduce treatment resistance in stage 4 and recurrent non- small cell lung
      cancer participants.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of Grade 3 toxicity
time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
description: CTCAE v5.0
measure: Occurrence of Grade 4 toxicity
time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
description: CTCAE v5.0
measure: Overall response rate (ORR) of participants
time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
description: RECIST 1.1
measure: Progression Free Survival (PFS)
time frame: From Cycle 1 day 1 (Each cycle is 21 days) for up to 2 years after end of treatment
description: RECIST 1.1
measure: 1-year overall survival (OS) rate: Proportion of participants alive at 1 year from Cycle 1 day 1
time frame: Cycle 1 day 1 up to 1 year post-Cycle 1 day 1 (Each cycle is 21 days)
description: Medical records
arm group label: Treatment
arm group type: Experimental
description: Atezolizumab (Tecentriq) intravenous (IV) 1200mg flat dose day 1 then every 3 weeks.
Pirfenidone (Esbriet) orally (PO) with food according to this schedule:
Days 1-14: 267 milligrams (mg) orally three times per day (PO TID) Days 15-29: 534 mg PO TID Days 30 onward until progression: 801 mg PO TID
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab is given as an intravenous infusion at 1200 mg every 3 weeks. Pirfenidone is taken by mouth 3 times a day with the dose increasing every 2 week until day 30
arm group label: Treatment
other name: Pirfenidone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chao Huang, MD
role: Principal Investigator
affiliation: The University of Kansas
last name: KUCC Navigator
phone: 9135883671
email: KUCC_Navigation@kumc.edu
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Pirfenidone
mesh term: Atezolizumab
sharing ipd: No