<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/NCT04497584</url>
  </required_header>
  <id_info>
    <org_study_id>STU-2020-0509</org_study_id>
    <nct_id>NCT04497584</nct_id>
  </id_info>
  <brief_title>Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC</brief_title>
  <official_title>An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the efficacy of combined afatinib and prednisone in previously treated advanced&#xD;
      squamous NSCLC&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This two-stage phase 2 study will determine the safety, tolerability, recommended phase 2&#xD;
      dose/maximum tolerated dose, preliminary efficacy and predictive/pharmacodynamic biomarkers&#xD;
      of combined EGFR inhibition (afatinib) and TNF inhibition (prednisone) in previously treated&#xD;
      NSCLC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 4, 2021</start_date>
  <completion_date type="Anticipated">September 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</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>
    <intervention_model_description>Afatinib 40 mg PO daily Prednisone 40 mg PO daily (starting 7 days after afatinib)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival of combined afatinib and prednisone in previously treated NSCLC</measure>
    <time_frame>From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months</time_frame>
    <description>Measure progression-free survival rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response rate of combined afatinib and prednisone in previously treated NSCLC</measure>
    <time_frame>From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months</time_frame>
    <description>Measure response rate by evaluation of target lesions by measuring disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival of combined afatinib and prednisone in previously treated NSCLC</measure>
    <time_frame>From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months</time_frame>
    <description>Measure Overall Survival, as the time from the date of initiation of study treatment until death of any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of combined afatinib and prednisone in previously treated NSCLC</measure>
    <time_frame>From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months</time_frame>
    <description>Measure risk to study participants by completing blood test and assessing according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">37</enrollment>
  <condition>Advanced Squamous Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Afatinib + Prednisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Afatinib 40 mg PO daily&#xD;
Prednisone 40 mg PO daily starting 7 days after Afatinib</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Afatinib + Prednisone</intervention_name>
    <description>Afatinib (40mg) will be taken by mouth daily starting on Cycle 1, Day -7. Prednisone (40mg) will be taken by mouth daily starting on Cycle 1, Day 1.</description>
    <arm_group_label>Afatinib + Prednisone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent in accordance with federal, local, and institutional&#xD;
             guidelines. The patient must provide informed consent prior to the first screening&#xD;
             procedure.&#xD;
&#xD;
          -  Previously treated (up to three prior lines of therapy), histologically proven&#xD;
             advanced squamous NSCLC.&#xD;
&#xD;
          -  No prior treatment with EGFR inhibitors, IMIDs (eg, thalidomide, lenalidomide), or&#xD;
             anti-TNF antibodies.&#xD;
&#xD;
          -  No treatment with systemic glucocorticoids within 3 weeks of initiation of study&#xD;
             therapy (topical and inhaled glucocorticoids are permitted).&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
&#xD;
          -  Adequate organ and marrow function as defined below:&#xD;
&#xD;
          -  absolute neutrophil count ≥ 1,000/μL&#xD;
&#xD;
          -  platelets ≥ 50,000/μl&#xD;
&#xD;
          -  total bilirubin within normal institutional limits&#xD;
&#xD;
          -  AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal&#xD;
&#xD;
          -  CrCl ≥ 45 ml/min&#xD;
&#xD;
          -  For both male and female patients, effective methods of contraception must be used&#xD;
             throughout the study and for 3 months following the last dose of study treatment.&#xD;
&#xD;
          -  Adequate archival tissue (5-10 slides) for correlative studies.&#xD;
&#xD;
          -  Subject must have measurable disease per RECIST 1.1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chemotherapy, radiotherapy, or other cancer therapy within two weeks prior to starting&#xD;
             study treatment. Subjects must have recovered from prior treatment-related to&#xD;
             toxicities to grade 1 or baseline (excluding alopecia and clinically stable toxicities&#xD;
             requiring ongoing medical management, such as hypothyroidism from prior immune&#xD;
             checkpoint inhibitor treatment).&#xD;
&#xD;
          -  Subjects may not be receiving any other investigational agents for the treatment of&#xD;
             the cancer under study.&#xD;
&#xD;
          -  Symptomatic brain metastases or brain metastases requiring escalating doses of&#xD;
             corticosteroids&#xD;
&#xD;
          -  History of hypersensitivity or allergic reactions attributed to afatinib or&#xD;
             prednisone.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including but not limited to poorly controlled&#xD;
             diabetes (which may worsen in setting of chronic prednisone therapy), symptomatic&#xD;
             congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric&#xD;
             illness/social situations that, in the opinion of the investigator, would limit&#xD;
             compliance with study requirements.&#xD;
&#xD;
          -  Subjects must not be pregnant or nursing due to the potential for congenital&#xD;
             abnormalities and the potential of this regimen to harm nursing infants.&#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>Sheena Bhalla, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sheena Bhalla, MD</last_name>
    <phone>214-648-4180</phone>
    <email>sheena.bhalla@utsouthwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ebele Mbanugo</last_name>
    <email>ebele.mbanugo@utsouthwestern.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ebele Mbanugo</last_name>
      <email>ebele.mbanugo@utsouthwestern.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>June 22, 2023</last_update_submitted>
  <last_update_submitted_qc>June 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Sheena Bhalla</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <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>Prednisone</mesh_term>
    <mesh_term>Afatinib</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/NCT04497584
org study id: STU-2020-0509
nct id: NCT04497584
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To determine the efficacy of combined afatinib and prednisone in previously treated advanced
      squamous NSCLC
This two-stage phase 2 study will determine the safety, tolerability, recommended phase 2
      dose/maximum tolerated dose, preliminary efficacy and predictive/pharmacodynamic biomarkers
      of combined EGFR inhibition (afatinib) and TNF inhibition (prednisone) in previously treated
      NSCLC.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Afatinib 40 mg PO daily Prednisone 40 mg PO daily (starting 7 days after afatinib)
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival of combined afatinib and prednisone in previously treated NSCLC
time frame: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
description: Measure progression-free survival rate.
measure: Response rate of combined afatinib and prednisone in previously treated NSCLC
time frame: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
description: Measure response rate by evaluation of target lesions by measuring disease.
measure: Overall survival of combined afatinib and prednisone in previously treated NSCLC
time frame: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
description: Measure Overall Survival, as the time from the date of initiation of study treatment until death of any cause.
measure: Safety of combined afatinib and prednisone in previously treated NSCLC
time frame: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
description: Measure risk to study participants by completing blood test and assessing according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0.
arm group label: Afatinib + Prednisone
arm group type: Experimental
description: Afatinib 40 mg PO daily
Prednisone 40 mg PO daily starting 7 days after Afatinib
intervention type: Drug
intervention name: Afatinib + Prednisone
description: Afatinib (40mg) will be taken by mouth daily starting on Cycle 1, Day -7. Prednisone (40mg) will be taken by mouth daily starting on Cycle 1, Day 1.
arm group label: Afatinib + Prednisone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sheena Bhalla, MD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
last name: Sheena Bhalla, MD
phone: 214-648-4180
email: sheena.bhalla@utsouthwestern.edu
last name: Ebele Mbanugo
email: ebele.mbanugo@utsouthwestern.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Sheena Bhalla
investigator title: Assistant Professor of Medicine
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Prednisone
mesh term: Afatinib
sharing ipd: No