<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/NCT03289780</url>
  </required_header>
  <id_info>
    <org_study_id>BDX-00146</org_study_id>
    <nct_id>NCT03289780</nct_id>
  </id_info>
  <brief_title>Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects</brief_title>
  <acronym>INSIGHT</acronym>
  <official_title>An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects With Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biodesix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biodesix, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to collect information about how a doctor uses the results of&#xD;
      the VeriStrat® blood test to guide treatment for non-small cell lung cancer (NSCLC) patients.&#xD;
      Understanding how VeriStrat test results influence doctors' decisions and patients' outcomes&#xD;
      may help doctors to better treat NSCLC in the future. This study will also look to establish&#xD;
      whether new investigational tests can help better predict the effectiveness of certain&#xD;
      medications for certain patients. These new investigational tests are only for research&#xD;
      purposes at this time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary purpose of this observational study is to assess the physician's clinical&#xD;
      practice patterns while using VeriStrat testing in subjects with NSCLC whose tumors are&#xD;
      epidermal growth factor receptor (EGFR) wild-type (negative) or have unknown EGFR mutational&#xD;
      status. This study will also attempt to further validate that VeriStrat test results stratify&#xD;
      subjects by clinical outcomes in the real world, uncontrolled clinical setting while&#xD;
      exploring whether certain therapeutic approaches may yield opportunities for further study.&#xD;
&#xD;
      Predictive tests that aid physician therapeutic decision making are critical for optimizing&#xD;
      subject outcomes while minimizing toxicity and associated treatment costs. This study will&#xD;
      provide data for the validation of immunotherapy tests currently being developed.&#xD;
      Immunotherapy mechanisms are dependent upon the interactions between the tumor, tumor&#xD;
      microenvironment, and the patient immune system. As such, a successful predictive test will&#xD;
      reflect the complex interplay between tumor and host. The multivariate tests from Biodesix&#xD;
      have the advantage of being able to assess this complex biology.&#xD;
&#xD;
      The information gained from this research will not only guide the adoption of the VeriStrat&#xD;
      test and inform medical decision making, including treatment choice, but will allow the&#xD;
      validation of additional mass-spectrometry-based proteomic tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 4, 2016</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physician Treatment Patterns Description</measure>
    <time_frame>3 years</time_frame>
    <description>Physician Treatment patterns Description: To describe physician treatment patterns pre and post-veriStrat testing. Describe the impact of the VeriStrat test results on treatment decisions, including but not limited to: percentage change in treatment decision, differences in chosen treatments between patients classified as VeriStrat good and those classified as VeriStrat Poor. Change in percentage of patients receiving systemic therapy or supportive therapies only.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunotherapy Stratification by Overall Survival</measure>
    <time_frame>3 years</time_frame>
    <description>To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by overall survival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunotherapy Stratification by Progression-Free Survival</measure>
    <time_frame>3 years</time_frame>
    <description>To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by progression-free survival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VeriStrat Poor vs. Good Outcomes</measure>
    <time_frame>3 years</time_frame>
    <description>To compare progression free survival (PFS) and overall survival (OS) outcomes between those classified as VeriStrat-Poor and VeriStrat-Good.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platinum-based therapy outcomes in VeriStrat Poor vs. Good subjects.</measure>
    <time_frame>3 years</time_frame>
    <description>To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with platinum-based therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunotherapy outcomes in VeriStrat Poor vs. Good subjects.</measure>
    <time_frame>3 years</time_frame>
    <description>To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with immunotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single agent chemotherapy outcomes in VeriStrat Poor vs. Good Subjects</measure>
    <time_frame>3 years</time_frame>
    <description>To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with single agent chemotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VeriStrat label changes over time.</measure>
    <time_frame>3 years</time_frame>
    <description>To compare the longitudinal changes in VeriStrat classification over the course of the study</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Determination of Immunotherapy tests ability to stratify subjects based on treatment.</measure>
    <time_frame>3 years</time_frame>
    <description>To determine whether immunotherapy test(s) stratify subjects treated with chemotherapy or targeted therapies by outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between the VeriStrat test and Immunotherapy tests.</measure>
    <time_frame>3 years</time_frame>
    <description>To observe the correlation between VeriStrat classification and immunotherapy test(s) classification at baseline and longitudinally.</description>
  </other_outcome>
  <other_outcome>
    <measure>Longitudinal changes in Immunotherapy tests.</measure>
    <time_frame>3 years</time_frame>
    <description>To describe the longitudinal changes in immunotherapy test classification over the course of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Stratification of Immunotherapy Test(s)</measure>
    <time_frame>3 years</time_frame>
    <description>To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by other clinically meaningful factors or endpoints.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in GeneStrat</measure>
    <time_frame>3 years</time_frame>
    <description>To observe changes in GeneStrat status across lines of therapy.</description>
  </other_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Any Subject with Non-Small Cell Lung Cancer (NSCLC) at all stages with any histology.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be 18 years of age or older at time of signing informed consent form&#xD;
             (ICF).&#xD;
&#xD;
          2. A diagnosis of NSCLC.&#xD;
&#xD;
          3. Subject is willing to provide serum samples for VeriStrat testing.&#xD;
&#xD;
          4. EGFR mutation status wild-type (negative) or a tested unknown.&#xD;
&#xD;
          5. For subjects with untested/unknown EGFR status only: The subject must be willing to&#xD;
             provide blood samples for GeneStrat testing.&#xD;
&#xD;
          6. Subject is willing to provide serum samples for research, understanding that no test&#xD;
             results will be made available either to the subject or the treating physician.&#xD;
&#xD;
          7. Subject is able to read and understand the ICF and agrees to comply with study&#xD;
             procedures and requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Subject's ability to understand the requirements of the protocol or to provide informed&#xD;
        consent is impaired or subject is unwilling to comply with the protocol requirements.&#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>Linda Traylor, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biodesix, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Niki Givens, B.S.</last_name>
    <phone>720-495-1583</phone>
    <email>niki.givens@biodesix.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Oncology Specialties, PC; Clearview Cancer Institute</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Lewis &amp; Faye Manderson Cancer Center at DCH Regional Medical Center</name>
      <address>
        <city>Tuscaloosa</city>
        <state>Alabama</state>
        <zip>35401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Danielle Daniel, RN</last_name>
      <phone>205-343-8331</phone>
      <email>danielle.daniel@dchsystem.com</email>
    </contact>
    <investigator>
      <last_name>John Dubay, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristi Noble, RN</last_name>
      <phone>479-878-5447</phone>
      <email>knoble@hogonc.com</email>
    </contact>
    <investigator>
      <last_name>Eric Schaefer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Bernards Cancer Center Hematology / Oncology</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amber Moon, RN</last_name>
      <phone>870-910-7723</phone>
      <email>amber.moon@cloptonclinic.com</email>
    </contact>
    <investigator>
      <last_name>Mazen Khalil, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aamer Farooq, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Valley Medical Oncology Consultants</name>
      <address>
        <city>Pleasanton</city>
        <state>California</state>
        <zip>94588</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Eastern Connecticut Hematology and Oncology Associates</name>
      <address>
        <city>Norwich</city>
        <state>Connecticut</state>
        <zip>06360</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Boca Raton Regional Hospital -Lynn Cancer Institute</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aubrey Gonzalez, RN</last_name>
      <phone>561-955-4519</phone>
      <email>agonzalez@brrh.com</email>
    </contact>
    <investigator>
      <last_name>Edgaurdo Santos, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lake City Cancer Care, LLC</name>
      <address>
        <city>Lake City</city>
        <state>Florida</state>
        <zip>32024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lanette Strosser, RN</last_name>
      <phone>386-755-1655</phone>
      <phone_ext>6214</phone_ext>
      <email>SLStrosser@ccofnf.com</email>
    </contact>
    <investigator>
      <last_name>Waseemullah Khan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vernon Montoya, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Uma Iyer, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>South Eastern Regional Medical Center</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Finger, BSHP</last_name>
      <phone>770-400-6077</phone>
      <email>elizabeth.Finger@ctca-hope.com</email>
    </contact>
    <contact_backup>
      <last_name>Mittie Mitchell, RN</last_name>
      <phone>770-400-7194</phone>
      <email>mittie.mitchell@ctca-hope.com</email>
    </contact_backup>
    <investigator>
      <last_name>Patricia Thompson-Rich, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Summit Cancer Care</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>South Georgia Medical Center</name>
      <address>
        <city>Valdosta</city>
        <state>Georgia</state>
        <zip>31602</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Zipperer, RN</last_name>
      <phone>229-259-4698</phone>
      <email>julie.zipperer@sgmc.org</email>
    </contact>
    <investigator>
      <last_name>Savita Bidyasar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Edward-Elmhurst Healthcare</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60540</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sofia Mikac, RN</last_name>
      <phone>630-646-6073</phone>
      <email>sofia.mikac@eehealth.org</email>
    </contact>
    <investigator>
      <last_name>Maria Quejada, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Care</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Boland</last_name>
      <phone>309-243-3617</phone>
      <email>jboland@illinoiscancercare.com</email>
    </contact>
    <investigator>
      <last_name>Gregory Gerstner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Franciscan St. Francis Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Franciscan Health Woodland Cancer Center</name>
      <address>
        <city>Michigan City</city>
        <state>Indiana</state>
        <zip>46360</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacklyn Gleser</last_name>
      <phone>219-861-5800</phone>
      <phone_ext>5819</phone_ext>
      <email>Jaclyn.Gleser@franciscanalliance.org</email>
    </contact>
    <investigator>
      <last_name>Olusola Ogundipe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ponchartrain Cancer Center</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chelsea McKean, RN</last_name>
      <phone>985-888-1523</phone>
      <email>chelsea@pcclouisiana.com</email>
    </contact>
    <investigator>
      <last_name>David Oubre, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Christus Health</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bernadine Norman, RN</last_name>
      <phone>318-466-6438</phone>
      <email>ramona.norman@christushealth.org</email>
    </contact>
    <investigator>
      <last_name>Suman Sinha, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Steven Saccaro, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Scott Boniol, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>North Mississippi Medical Center - Hematology and Oncology Clinic</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anthony Sommerford, RN</last_name>
      <phone>662-377-4550</phone>
      <email>aqsummerford@nmhs.net</email>
    </contact>
    <contact_backup>
      <last_name>Brian Donner, RN</last_name>
      <phone>662-377-4624</phone>
      <email>BCDonner@nmhs.net</email>
    </contact_backup>
    <investigator>
      <last_name>Tan Jiahuai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Central Care Cancer Center</name>
      <address>
        <city>Bolivar</city>
        <state>Missouri</state>
        <zip>65613</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsey Ankrom</last_name>
      <phone>417-328-6979</phone>
      <email>lindsey.ankrom@cccancer.com</email>
    </contact>
    <investigator>
      <last_name>Leo Shunyakov, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Phelps County Regional Medical Center</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Casey Burton, PhD</last_name>
      <phone>573-458-7043</phone>
      <email>cburton@pcrmc.com</email>
    </contact>
    <investigator>
      <last_name>Kan Huang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Medical</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Kahrs, RN</last_name>
      <phone>417-820-4587</phone>
      <email>jennifer.kahrs@mercy.net</email>
    </contact>
    <investigator>
      <last_name>Shravan Narmala, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kasey Coenen</last_name>
      <phone>402-354-5129</phone>
      <email>kacey.coenen@nmhs.org</email>
    </contact>
    <investigator>
      <last_name>Robert Langdon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Essex Oncology</name>
      <address>
        <city>Belleville</city>
        <state>New Jersey</state>
        <zip>07109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Johnstone</last_name>
      <phone>973-751-8880</phone>
      <phone_ext>272</phone_ext>
      <email>trials@essexoncology.com</email>
    </contact>
    <investigator>
      <last_name>James Orsini, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Said Saleh, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hemalatha Vasireddy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sita Yerramalli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>John Conti, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Susan Harrison, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New York Oncology Group</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Zuchelkowski</last_name>
      <phone>518-489-3612</phone>
      <phone_ext>1045</phone_ext>
      <email>amy.zuchelkowski@usoncology.com</email>
    </contact>
    <investigator>
      <last_name>John Phelan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>NYU Laura &amp; Isaac Perlmutter Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianna Kroening</last_name>
      <phone>212-263-0469</phone>
      <email>gianna.kroening@nyolangone.org</email>
    </contact>
    <investigator>
      <last_name>Velcheti Vamsidhar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashley Delgado</last_name>
      <phone>919-349-0496</phone>
      <email>ashley.delgado@med.unc.edu</email>
    </contact>
    <investigator>
      <last_name>Jason Akullan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Southeastern Medical Oncology</name>
      <address>
        <city>Goldsboro</city>
        <state>North Carolina</state>
        <zip>27534</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elaine Cooke, RN</last_name>
      <phone>919-587-9077</phone>
      <email>ecooke@cancersmoc.com</email>
    </contact>
    <investigator>
      <last_name>James Atkins, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Leo W. Jenkins Cancer Center - East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kaitlyn Walker, RN</last_name>
      <phone>252-744-1888</phone>
      <email>walkerkai16@ecu.edu</email>
    </contact>
    <investigator>
      <last_name>Paul Walker, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Darla Liles, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hematology and Oncology Associates - Mercy Medical Center</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44708</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joan Edwards, RN</last_name>
      <phone>330-489-1274</phone>
      <email>joan.edwards@cantonmercy.org</email>
    </contact>
    <investigator>
      <last_name>Mitchell Haut, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tri-County Hematology &amp; Oncology Associates</name>
      <address>
        <city>Massillon</city>
        <state>Ohio</state>
        <zip>44646</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joan Edwards, RN</last_name>
      <phone>330-489-1274</phone>
      <email>joan.edwards@cantonmercy.org</email>
    </contact>
    <investigator>
      <last_name>Nagaprasad Nagajothi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oregon Oncology Specialists (QCCA)</name>
      <address>
        <city>Salem</city>
        <state>Oregon</state>
        <zip>97301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Sinn</last_name>
      <email>msinn@orcancer.com</email>
    </contact>
    <contact_backup>
      <last_name>Julie E Hinson</last_name>
      <email>jhinson@orcancer.com</email>
    </contact_backup>
    <investigator>
      <last_name>Janelle Meyer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gettysburg Cancer Center</name>
      <address>
        <city>Gettysburg</city>
        <state>Pennsylvania</state>
        <zip>17325</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Bon Secours St. Francis Cancer Center</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Arlington Cancer Center</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>JPS Health Network, JPS Center for Cancer Care</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Celeste Caliman, RN</last_name>
      <phone>817-702-6776</phone>
      <email>ccaliman@jpshealth.org</email>
    </contact>
    <investigator>
      <last_name>Jordan Christopher, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bassam Ghabach, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Center for Cancer and Blood Disorders</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brandi Halstead, LVN</last_name>
      <phone>817-341-5414</phone>
      <email>bhalstead@txcc.com</email>
    </contact>
    <investigator>
      <last_name>Ray D Page, DO, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Scott &amp; White Memorial Hospital and Clinic</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Graves</last_name>
      <phone>801-587-4284</phone>
      <email>natalie.graves@hci.utah.edu</email>
    </contact>
    <contact_backup>
      <last_name>Nicole Hillman</last_name>
      <phone>801-213-4245</phone>
      <email>nicole.hillman@hci.utah.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Wallace Akerley, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Institute</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23230</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sue Moore, RN</last_name>
      <phone>804-288-7159</phone>
      <email>smoore@vacancer.com</email>
    </contact>
    <contact_backup>
      <last_name>Sylvia Neff, RN</last_name>
      <phone>804-287-3000</phone>
      <phone_ext>1263</phone_ext>
      <email>saneff@vacancer.com</email>
    </contact_backup>
    <investigator>
      <last_name>Brian Mitchell, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peace Health</name>
      <address>
        <city>Bellingham</city>
        <state>Washington</state>
        <zip>982256</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lauren Key, RN</last_name>
      <phone>360-788-8240</phone>
      <email>lkey@peacehealth.org</email>
    </contact>
    <investigator>
      <last_name>Scott LeTellier, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwest Medical Specialties, PLLC</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Sandefur, RN</last_name>
      <phone>253-428-8712</phone>
      <email>ssandefur@nwmsonline.com</email>
    </contact>
    <investigator>
      <last_name>Andrea Rose, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.biodesix.com</url>
    <description>Sponsor Website</description>
  </link>
  <reference>
    <citation>Akerley WL, Arnaud AM, Reddy B, Page RD. Impact of a multivariate serum-based proteomic test on physician treatment recommendations for advanced non-small-cell lung cancer. Curr Med Res Opin. 2017 Jun;33(6):1091-1097. doi: 10.1080/03007995.2017.1301903. Epub 2017 Mar 16.</citation>
    <PMID>28277859</PMID>
  </reference>
  <reference>
    <citation>Grossi F, Rijavec E, Genova C, Barletta G, Biello F, Maggioni C, Burrafato G, Sini C, Dal Bello MG, Meyer K, Roder J, Roder H, Grigorieva J. Serum proteomic test in advanced non-squamous non-small cell lung cancer treated in first line with standard chemotherapy. Br J Cancer. 2017 Jan 3;116(1):36-43. doi: 10.1038/bjc.2016.387. Epub 2016 Nov 29.</citation>
    <PMID>27898657</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2022</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>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03289780/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03289780/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03289780
org study id: BDX-00146
nct id: NCT03289780
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to collect information about how a doctor uses the results of
      the VeriStrat® blood test to guide treatment for non-small cell lung cancer (NSCLC) patients.
      Understanding how VeriStrat test results influence doctors' decisions and patients' outcomes
      may help doctors to better treat NSCLC in the future. This study will also look to establish
      whether new investigational tests can help better predict the effectiveness of certain
      medications for certain patients. These new investigational tests are only for research
      purposes at this time.
The primary purpose of this observational study is to assess the physician's clinical
      practice patterns while using VeriStrat testing in subjects with NSCLC whose tumors are
      epidermal growth factor receptor (EGFR) wild-type (negative) or have unknown EGFR mutational
      status. This study will also attempt to further validate that VeriStrat test results stratify
      subjects by clinical outcomes in the real world, uncontrolled clinical setting while
      exploring whether certain therapeutic approaches may yield opportunities for further study.

      Predictive tests that aid physician therapeutic decision making are critical for optimizing
      subject outcomes while minimizing toxicity and associated treatment costs. This study will
      provide data for the validation of immunotherapy tests currently being developed.
      Immunotherapy mechanisms are dependent upon the interactions between the tumor, tumor
      microenvironment, and the patient immune system. As such, a successful predictive test will
      reflect the complex interplay between tumor and host. The multivariate tests from Biodesix
      have the advantage of being able to assess this complex biology.

      The information gained from this research will not only guide the adoption of the VeriStrat
      test and inform medical decision making, including treatment choice, but will allow the
      validation of additional mass-spectrometry-based proteomic tests.
observational model: Cohort
time perspective: Prospective
measure: Physician Treatment Patterns Description
time frame: 3 years
description: Physician Treatment patterns Description: To describe physician treatment patterns pre and post-veriStrat testing. Describe the impact of the VeriStrat test results on treatment decisions, including but not limited to: percentage change in treatment decision, differences in chosen treatments between patients classified as VeriStrat good and those classified as VeriStrat Poor. Change in percentage of patients receiving systemic therapy or supportive therapies only.
measure: Immunotherapy Stratification by Overall Survival
time frame: 3 years
description: To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by overall survival.
measure: Immunotherapy Stratification by Progression-Free Survival
time frame: 3 years
description: To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by progression-free survival.
measure: VeriStrat Poor vs. Good Outcomes
time frame: 3 years
description: To compare progression free survival (PFS) and overall survival (OS) outcomes between those classified as VeriStrat-Poor and VeriStrat-Good.
measure: Platinum-based therapy outcomes in VeriStrat Poor vs. Good subjects.
time frame: 3 years
description: To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with platinum-based therapy.
measure: Immunotherapy outcomes in VeriStrat Poor vs. Good subjects.
time frame: 3 years
description: To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with immunotherapy.
measure: Single agent chemotherapy outcomes in VeriStrat Poor vs. Good Subjects
time frame: 3 years
description: To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with single agent chemotherapy.
measure: VeriStrat label changes over time.
time frame: 3 years
description: To compare the longitudinal changes in VeriStrat classification over the course of the study
measure: Determination of Immunotherapy tests ability to stratify subjects based on treatment.
time frame: 3 years
description: To determine whether immunotherapy test(s) stratify subjects treated with chemotherapy or targeted therapies by outcome.
measure: Correlation between the VeriStrat test and Immunotherapy tests.
time frame: 3 years
description: To observe the correlation between VeriStrat classification and immunotherapy test(s) classification at baseline and longitudinally.
measure: Longitudinal changes in Immunotherapy tests.
time frame: 3 years
description: To describe the longitudinal changes in immunotherapy test classification over the course of the study.
measure: Stratification of Immunotherapy Test(s)
time frame: 3 years
description: To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by other clinically meaningful factors or endpoints.
measure: Changes in GeneStrat
time frame: 3 years
description: To observe changes in GeneStrat status across lines of therapy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Linda Traylor, Ph.D
role: Principal Investigator
affiliation: Biodesix, Inc.
last name: Niki Givens, B.S.
phone: 720-495-1583
email: niki.givens@biodesix.com
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.biodesix.com
description: Sponsor Website
citation: Akerley WL, Arnaud AM, Reddy B, Page RD. Impact of a multivariate serum-based proteomic test on physician treatment recommendations for advanced non-small-cell lung cancer. Curr Med Res Opin. 2017 Jun;33(6):1091-1097. doi: 10.1080/03007995.2017.1301903. Epub 2017 Mar 16.
PMID: 28277859
citation: Grossi F, Rijavec E, Genova C, Barletta G, Biello F, Maggioni C, Burrafato G, Sini C, Dal Bello MG, Meyer K, Roder J, Roder H, Grigorieva J. Serum proteomic test in advanced non-squamous non-small cell lung cancer treated in first line with standard chemotherapy. Br J Cancer. 2017 Jan 3;116(1):36-43. doi: 10.1038/bjc.2016.387. Epub 2016 Nov 29.
PMID: 27898657
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No
provided document: 
provided document: 