xml: <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/NCT06038526</url>
    </required_header>
    <id_info>
      <org_study_id>OSU-22297</org_study_id>
      <secondary_id>NCI-2023-05942</secondary_id>
      <nct_id>NCT06038526</nct_id>
    </id_info>
    <brief_title>Evaluation of Canakinumab in High-Risk Former-Smokers</brief_title>
    <official_title>Molecular Studies of Canakinumab in High-Risk Former-Smokers (CANIFS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peter Shields</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ohio State University Comprehensive Cancer 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>
        This phase II trial tests the impact of canakinumab on biologic samples (buccal, nasal, and&#xD;
        blood) from former smokers with increased risk of cancer. Canakinumab blocks the activity of&#xD;
        a protein called interleukin-1 beta (IL-1b), an agent of the inflammatory system and is used&#xD;
        for the treatment of different non-cancer diseases (like auto-inflammatory diseases). Giving&#xD;
        canakinumab may block the inflammatory system and could have positive effects to reduce&#xD;
        cancer growth.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To compare baseline bronchoscopy biospecimens with samples approximately 70 days after&#xD;
        administration of canakinumab (2 doses, approximately 14 days apart) in healthy former&#xD;
        smokers.&#xD;
  &#xD;
        SECONDARY OBJECTIVE:&#xD;
  &#xD;
        I. Determine the impact of IL-1beta inhibition on downstream inflammatory pathways.&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Patients undergo bronchoscopy over 30-60 minutes on day 7 and receive canakinumab&#xD;
        subcutaneously (SC) 60 minutes and 2 weeks after the initial bronchoscopy. Patients undergo&#xD;
        an additional bronchoscopy on day 77. Patients undergo buccal, nasal, and blood sample&#xD;
        collection and carbon monoxide (CO testing on study).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in ASCs</measure>
      <time_frame>At baseline and day 77</time_frame>
      <description>Will be assessed by a generalized linear mixed model (GLM) and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in caspase-1</measure>
      <time_frame>At baseline and day 77</time_frame>
      <description>Will be assessed by a GLM and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in interleukin-1 beta (IL-1beta)</measure>
      <time_frame>At baseline and day 77</time_frame>
      <description>Will be assessed by a GLM and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in immune cell composition in bronchoalveolar lavage (BAL) by mass cytometry (CyTOF)</measure>
      <time_frame>At baseline and day 77</time_frame>
      <description>Will be performed using SPADE to create a global map of cell types present across samples and how the frequency or activation state of each cell type differs between baseline vs. follow-up (single arm). Will assess batch effects and include batch as a co-variable in the models. Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by ribonucleic acid sequence (RNASeq).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in cytokines in the blood</measure>
      <time_frame>At baseline and day 77</time_frame>
      <description>Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by RNASeq.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in BAL</measure>
      <time_frame>At baseline and day 77</time_frame>
      <description>Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by RNASeq.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bronchoscopy for fractional concentration of exhaled nitric oxide (FeNO)</measure>
      <time_frame>At baseline and day 77</time_frame>
      <description>Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by RNASeq.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Cigarette Smoking-Related Carcinoma</condition>
    <condition>Lung Carcinoma</condition>
    <arm_group>
      <arm_group_label>Prevention (canakinumab, bronchoscopy)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients undergo bronchoscopy over 30-60 minutes and receive canakinumab SC 60 minutes and 2 weeks after the initial bronchoscopy. Patients undergo an additional bronchoscopy on day 77. Patients undergo buccal, nasal, and blood sample collection and CO testing on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biospecimen Collection</intervention_name>
      <description>Undergo buccal, nasal, and blood sample collection</description>
      <arm_group_label>Prevention (canakinumab, bronchoscopy)</arm_group_label>
      <other_name>Biological Sample Collection</other_name>
      <other_name>Biospecimen Collected</other_name>
      <other_name>Specimen Collection</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Bronchoscopy</intervention_name>
      <description>Undergo bronchoscopy</description>
      <arm_group_label>Prevention (canakinumab, bronchoscopy)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Canakinumab</intervention_name>
      <description>Given SC</description>
      <arm_group_label>Prevention (canakinumab, bronchoscopy)</arm_group_label>
      <other_name>ACZ885</other_name>
      <other_name>Ilaris</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Carbon Monoxide Measurement</intervention_name>
      <description>Undergo CO testing</description>
      <arm_group_label>Prevention (canakinumab, bronchoscopy)</arm_group_label>
      <other_name>Carbon Monoxide</other_name>
      <other_name>CMONOX</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Prevention (canakinumab, bronchoscopy)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 55-73 (age criteria aligns with Canakinumab Antiinflammatory Thrombosis Outcome&#xD;
               Study [CANTOS] trial)&#xD;
  &#xD;
            -  If female: evidence of post-menopausal status or negative urinary or serum pregnancy&#xD;
               test (unknown impact on pregnancy).&#xD;
  &#xD;
          Women of child-bearing potential, defined as all women physiologically capable of becoming&#xD;
          pregnant, unless they are using highly effective methods of contraception while taking&#xD;
          study treatment and for 6 weeks after stopping medication. Highly effective contraception&#xD;
          methods include:&#xD;
  &#xD;
          Total abstinence (when this is in line with the preferred and usual lifestyle of the&#xD;
          participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation&#xD;
          methods) and withdrawal are not acceptable methods of contraception.&#xD;
  &#xD;
            -  Female sterilization (have had surgical bilateral oophorectomy with or without&#xD;
               hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks&#xD;
               before taking study treatment. In case of oophorectomy alone, only when the&#xD;
               reproductive status of the woman has been confirmed by follow up hormone level&#xD;
               assessment.&#xD;
  &#xD;
            -  Male sterilization (at least 6 months prior to screening). For female participants on&#xD;
               the study, the vasectomized male partner should be the sole partner for that&#xD;
               participant&#xD;
  &#xD;
            -  Use of oral, (estrogen and progesterone), injected, or implanted hormonal methods of&#xD;
               contraception or placement of an intrauterine device (IUD) or intrauterine system&#xD;
               (IUS), or other forms of hormonal contraception that have comparable efficacy (failure&#xD;
               rate &lt; 1%), for example hormone vaginal ring or transdermal hormone contraception. In&#xD;
               case of use of oral contraception women should have been stable on the same pill for a&#xD;
               minimum of 3 months before taking study treatment.&#xD;
  &#xD;
          Women are considered post-menopausal if they have had 12 months of natural (spontaneous)&#xD;
          amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor&#xD;
          symptoms). Women are considered not of a childbearing potential if they are post-menopausal&#xD;
          or have had surgical bilateral oophorectomy (with or without hysterectomy), total&#xD;
          hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of&#xD;
          oophorectomy alone, only when the reproductive status of the woman has been confirmed by&#xD;
          follow up hormone level assessment is she considered not of childbearing potential.&#xD;
  &#xD;
          Women will also be considered post-menopausal if they have been amenorrhoeic for 12 months&#xD;
          without an alter-native medical cause. The following age-specific requirements apply:&#xD;
  &#xD;
            -  Women &gt;= 50 years of age would be considered post-menopausal if they have been&#xD;
               amenorrhoeic for 12 months or more following cessation of all exogenous hormonal&#xD;
               treatments, had radiation-induced menopause with last menses &gt; 1 year ago, had&#xD;
               chemotherapy-induced menopause with last menses &gt; 1 year ago, or underwent surgical&#xD;
               sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)&#xD;
  &#xD;
                 -  Former smoker with no use in &gt;= 5 years prior to enrollment (targets former&#xD;
                    smoker population)&#xD;
  &#xD;
                 -  CO =&lt; 8ppm (targets/confirms former smoker population)&#xD;
  &#xD;
                 -  Pack-years history of &gt;= 30 (defined as high risk)&#xD;
  &#xD;
                 -  No unstable or significant medical conditions as determined by medical history&#xD;
                    (see exclusion criteria below - to ensure safety of the subject, to minimize the&#xD;
                    effects of poor health on biomarker measures and to maximize compliance to study&#xD;
                    procedures)&#xD;
  &#xD;
                 -  C-reactive protein high-sensitivity (hsCRP) levels &gt;= 2 mg/L (defined as&#xD;
                    increased risk)&#xD;
  &#xD;
                 -  Negative coronavirus disease (COVID-19) test (if applicable). According to&#xD;
                    institutional standards, which may evolve throughout the study, if a subject&#xD;
                    self-reports testing positive for COVID-19, the condition should be resolved&#xD;
                    without ongoing symptoms for at least three months. If a subject tests positive&#xD;
                    before the first bronchoscopy, the subject would be placed on a wait list for at&#xD;
                    least three months and re-tested before his/her appointment; if a subject tests&#xD;
                    positive before a follow-up bronchoscopy, his/her participation will be withdrawn&#xD;
                    by the principal investigator (PI)&#xD;
  &#xD;
                 -  Able to read adequately to complete the survey and related study documents or&#xD;
                    give consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smoked tobacco or cannabis within 5 years of enrollment (target study population is&#xD;
               former smokers)&#xD;
  &#xD;
            -  Used an electronic cigarette or vaped including tetrahydrocannabinol (THC) within 5&#xD;
               years of enrollment (impacts biomarkers). Smoking or vaping any form of tobacco&#xD;
               product or cannabis/THC is an exclusion; however, other use of THC administration&#xD;
               (e.g., edible, topical, etc.) are permitted&#xD;
  &#xD;
            -  CO &gt; 8ppm (target study population is former smokers)&#xD;
  &#xD;
            -  History of or recent exposure to tuberculosis (TB) as documented in the electronic&#xD;
               medical record (EMR) and/or testing (impacts risk)&#xD;
  &#xD;
            -  Body mass index (BMI) &gt; 45 (risk of unstable airway)&#xD;
  &#xD;
            -  Taking acetylsalicylic acid (ASA) or nonsteroidal anti-inflammatory drugs (NSAIDs)&#xD;
               daily or most days per week (impacts biomarkers and risk)&#xD;
  &#xD;
            -  Concomitant diseases and life-threatening conditions (e.g., cancer or kidney, liver,&#xD;
               immune system disorders)&#xD;
  &#xD;
            -  Prior diagnosis of chronic pulmonary disease (e.g., asthma with regular use of&#xD;
               medications, chronic bronchitis, and restrictive lung disease) (impacts biomarkers and&#xD;
               risk)&#xD;
  &#xD;
            -  Acute bronchitis or pneumonia within 1 year (impacts biomarkers)&#xD;
  &#xD;
            -  COVID-19 diagnosis or related symptoms within the last 3 months (impacts biomarkers&#xD;
               and risk). According to institutional standards, which may evolve throughout the&#xD;
               study, if a subject self-reports testing positive for COVID-19, the condition should&#xD;
               be resolved without ongoing symptoms for at least three months. If a subject tests&#xD;
               positive before the first bronchoscopy, the subject would be placed on a wait list for&#xD;
               at least three months and re-tested before his/her appointment; if a subject tests&#xD;
               positive before a follow-up bronchoscopy, his/her participation will be withdrawn by&#xD;
               the PI&#xD;
  &#xD;
            -  General anesthesia within 1 year (impacts biomarkers)&#xD;
  &#xD;
            -  Regular use of inhalant medications in the last 3 months (impacts biomarkers)&#xD;
  &#xD;
            -  Use of antibiotics in prior 30 days (impacts biomarkers)&#xD;
  &#xD;
            -  Use of steroids, including corticosteroids and inhaled corticosteroids, in prior 30&#xD;
               days (impacts biomarkers)&#xD;
  &#xD;
            -  Use of prohibited concomitant therapy including but not limited to immunosuppressants&#xD;
               (impacts biomarkers and risk). Prohibited concomitant therapy:&#xD;
  &#xD;
                 -  Immunosuppressants&#xD;
  &#xD;
                 -  Use of any treatments below is NOT allowed after the start of study treatment due&#xD;
                    to potential increase in immunosuppressant related concomitant conditions. They&#xD;
                    are prohibited for the duration of the study and for at least 130 days after&#xD;
                    discontinuation of study treatment. If a subject chooses to continue one of the&#xD;
                    medications below, they will be followed.&#xD;
  &#xD;
                      -  Anti-retro-viral and / or biologic drugs targeting the immune system (e.g.,&#xD;
                         TNF blockers, anakinra, rituximab, abatacept, tocilizumab)&#xD;
  &#xD;
                      -  Immune modulating agent in doses with systemic effects including but not&#xD;
                         limited to&#xD;
  &#xD;
                           -  Prednisone &gt; 20 mg (or equivalent) oral or intravenous daily for &gt; 14&#xD;
                              days;&#xD;
  &#xD;
                           -  Prednisone &gt; 5 mg and =&lt; 20 mg (or equivalent) daily for &gt; 30 days;&#xD;
  &#xD;
                           -  Equivalent dose of methotrexate &gt; 15 mg weekly.&#xD;
  &#xD;
                 -  Cytochrome P450 Substrates - The formation of CYP450 enzymes is suppressed by&#xD;
                    increased levels of cytokines (e.g., IL-1) during chronic inflammation. Thus, it&#xD;
                    is expected that for a molecule that binds to IL-1, such as canakinumab, the&#xD;
                    formation of CYP450 enzymes could be normalized. This is clinically relevant for&#xD;
                    CYP450 substrates with a narrow therapeutic index, where the dose is individually&#xD;
                    adjusted (e.g., warfarin). Upon initiation of canakinumab, in patients being&#xD;
                    treated with these types of medicinal products, therapeutic monitoring of the&#xD;
                    effect or drug concentration should be performed and the individual dose of the&#xD;
                    medicinal product may need to be adjusted as needed&#xD;
  &#xD;
            -  Live or attenuated vaccines within 90 days of study treatment and after initiation of&#xD;
               study drug (impacts biomarkers and risk). Subjects must be discontinued from the trial&#xD;
               if administered any live or attenuated vaccine during the course of the study&#xD;
  &#xD;
            -  Allergies to study medications, such as, lidocaine, versed, fentanyl or cetacaine&#xD;
               (impacts risk)&#xD;
  &#xD;
            -  Bronchoscopy or any other lung procedure for any reason within the previous 6 months&#xD;
               (impacts biomarkers)&#xD;
  &#xD;
            -  Current or recent (within three months) alcohol or drug abuse problems (impacts risk)&#xD;
  &#xD;
            -  Unable to read for comprehension or completion of study documents (impacts risk)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>73 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Peter G Shields, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>The Ohio State Comprehensive Cancer Center</last_name>
      <phone>800-293-5066</phone>
      <email>OSUCCCClinicaltrials@osumc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ohio State University Comprehensive Cancer Center</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43210</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Peter G. Shields, MD</last_name>
        <phone>614-688-6563</phone>
        <email>peter.shields@osumc.edu</email>
      </contact>
      <investigator>
        <last_name>Peter G. Shields, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://cancer.osu.edu</url>
      <description>The Jamesline</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
      <investigator_full_name>Peter Shields</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</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carbon Monoxide</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038526
  org study id: OSU-22297
  secondary id: NCI-2023-05942
  nct id: NCT06038526
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This phase II trial tests the impact of canakinumab on biologic samples (buccal, nasal, and
        blood) from former smokers with increased risk of cancer. Canakinumab blocks the activity of
        a protein called interleukin-1 beta (IL-1b), an agent of the inflammatory system and is used
        for the treatment of different non-cancer diseases (like auto-inflammatory diseases). Giving
        canakinumab may block the inflammatory system and could have positive effects to reduce
        cancer growth.
  PRIMARY OBJECTIVE:
  
        I. To compare baseline bronchoscopy biospecimens with samples approximately 70 days after
        administration of canakinumab (2 doses, approximately 14 days apart) in healthy former
        smokers.
  
        SECONDARY OBJECTIVE:
  
        I. Determine the impact of IL-1beta inhibition on downstream inflammatory pathways.
  
        OUTLINE:
  
        Patients undergo bronchoscopy over 30-60 minutes on day 7 and receive canakinumab
        subcutaneously (SC) 60 minutes and 2 weeks after the initial bronchoscopy. Patients undergo
        an additional bronchoscopy on day 77. Patients undergo buccal, nasal, and blood sample
        collection and carbon monoxide (CO testing on study).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in ASCs
  time frame: At baseline and day 77
  description: Will be assessed by a generalized linear mixed model (GLM) and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.
  measure: Change in caspase-1
  time frame: At baseline and day 77
  description: Will be assessed by a GLM and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.
  measure: Change in interleukin-1 beta (IL-1beta)
  time frame: At baseline and day 77
  description: Will be assessed by a GLM and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.
  measure: Changes in immune cell composition in bronchoalveolar lavage (BAL) by mass cytometry (CyTOF)
  time frame: At baseline and day 77
  description: Will be performed using SPADE to create a global map of cell types present across samples and how the frequency or activation state of each cell type differs between baseline vs. follow-up (single arm). Will assess batch effects and include batch as a co-variable in the models. Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by ribonucleic acid sequence (RNASeq).
  measure: Changes in cytokines in the blood
  time frame: At baseline and day 77
  description: Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by RNASeq.
  measure: Changes in BAL
  time frame: At baseline and day 77
  description: Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by RNASeq.
  measure: Bronchoscopy for fractional concentration of exhaled nitric oxide (FeNO)
  time frame: At baseline and day 77
  description: Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by RNASeq.
  arm group label: Prevention (canakinumab, bronchoscopy)
  arm group type: Experimental
  description: Patients undergo bronchoscopy over 30-60 minutes and receive canakinumab SC 60 minutes and 2 weeks after the initial bronchoscopy. Patients undergo an additional bronchoscopy on day 77. Patients undergo buccal, nasal, and blood sample collection and CO testing on study.
  intervention type: Procedure
  intervention name: Biospecimen Collection
  description: Undergo buccal, nasal, and blood sample collection
  arm group label: Prevention (canakinumab, bronchoscopy)
  other name: Biological Sample Collection
  other name: Biospecimen Collected
  other name: Specimen Collection
  intervention type: Procedure
  intervention name: Bronchoscopy
  description: Undergo bronchoscopy
  arm group label: Prevention (canakinumab, bronchoscopy)
  intervention type: Biological
  intervention name: Canakinumab
  description: Given SC
  arm group label: Prevention (canakinumab, bronchoscopy)
  other name: ACZ885
  other name: Ilaris
  intervention type: Procedure
  intervention name: Carbon Monoxide Measurement
  description: Undergo CO testing
  arm group label: Prevention (canakinumab, bronchoscopy)
  other name: Carbon Monoxide
  other name: CMONOX
  intervention type: Other
  intervention name: Survey Administration
  description: Ancillary studies
  arm group label: Prevention (canakinumab, bronchoscopy)
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 73 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Peter G Shields, MD
  role: Principal Investigator
  affiliation: Ohio State University Comprehensive Cancer Center
  last name: The Ohio State Comprehensive Cancer Center
  phone: 800-293-5066
  email: OSUCCCClinicaltrials@osumc.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  url: http://cancer.osu.edu
  description: The Jamesline
  responsible party type: Sponsor-Investigator
  investigator affiliation: Ohio State University Comprehensive Cancer Center
  investigator full name: Peter Shields
  investigator title: Principal Investigator
  mesh term: Carcinoma
  mesh term: Carbon Monoxide
  sharing ipd: No