Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects (INSIGHT)

An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects With Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small Cell Lung Cancer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 5006

Contacts and Locations

• Study Contact: Name: Niki Givens, B.S.; Phone Number: 720-495-1583; Email: niki.givens@biodesix.com

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Oncology Specialties, PC; Clearview Cancer Institute
    • Tuscaloosa, Alabama, United States, 35401
      • Lewis & Faye Manderson Cancer Center at DCH Regional Medical Center
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernards Cancer Center Hematology / Oncology
  • California
    • Pleasanton, California, United States, 94588
      • Valley Medical Oncology Consultants
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Eastern Connecticut Hematology and Oncology Associates
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital -Lynn Cancer Institute
    • Lake City, Florida, United States, 32024
      • Lake City Cancer Care, LLC
  • Georgia
    • Newnan, Georgia, United States, 30265
      • South Eastern Regional Medical Center
    • Savannah, Georgia, United States, 31405
      • Summit Cancer Care
    • Valdosta, Georgia, United States, 31602
      • South Georgia Medical Center
  • Illinois
    • Naperville, Illinois, United States, 60540
      • Edward-Elmhurst Healthcare
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan St. Francis Health
    • Michigan City, Indiana, United States, 46360
      • Franciscan Health Woodland Cancer Center
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Ponchartrain Cancer Center
    • Shreveport, Louisiana, United States, 71105
      • CHRISTUS Health
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center - Hematology and Oncology Clinic
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Central Care Cancer Center
    • Rolla, Missouri, United States, 65401
      • Phelps County Regional Medical Center
    • Springfield, Missouri, United States, 65804
      • Mercy Medical
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • Essex Oncology
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Group
    • Lake Success, New York, United States, 11042
      • Clinical Research Associates
    • New York, New York, United States, 10016
      • NYU Laura & Isaac Perlmutter Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • University of North Carolina
    • Goldsboro, North Carolina, United States, 27534
      • Southeastern Medical Oncology
    • Greenville, North Carolina, United States, 27834
      • Leo W. Jenkins Cancer Center - East Carolina University
  • Ohio
    • Canton, Ohio, United States, 44708
      • Hematology and Oncology Associates - Mercy Medical Center
    • Massillon, Ohio, United States, 44646
      • Tri-County Hematology & Oncology Associates
  • Oregon
    • Salem, Oregon, United States, 97301
      • Oregon Oncology Specialists (QCCA)
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Bon Secours St. Francis Cancer Center
  • Texas
    • Arlington, Texas, United States, 76012
      • Arlington Cancer Center
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
    • Fort Worth, Texas, United States, 76104
      • JPS Health Network, JPS Center for Cancer Care
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital And Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Virginia
    • Richmond, Virginia, United States, 23230
      • Virginia Cancer Institute
  • Washington
    • Bellingham, Washington, United States, 982256
      • Peace Health
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any Subject with Non-Small Cell Lung Cancer (NSCLC) at all stages with any histology.

Description

Inclusion Criteria:

1. Subject must be 18 years of age or older at time of signing informed consent form (ICF).
2. A diagnosis of NSCLC.
3. Subject is willing to provide serum samples for VeriStrat testing.
4. EGFR mutation status wild-type (negative) or a tested unknown.
5. For subjects with untested/unknown EGFR status only: The subject must be willing to provide blood samples for GeneStrat testing.
6. Subject is willing to provide serum samples for research, understanding that no test results will be made available either to the subject or the treating physician.
7. Subject is able to read and understand the ICF and agrees to comply with study procedures and requirements.

Exclusion Criteria:

1. Subject's ability to understand the requirements of the protocol or to provide informed consent is impaired or subject is unwilling to comply with the protocol requirements.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Treatment Patterns 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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunotherapy Stratification by Overall Survival	To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by overall survival.	3 years
Immunotherapy Stratification by Progression-Free Survival	To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by progression-free survival.	3 years
VeriStrat Poor vs. Good Outcomes	To compare progression free survival (PFS) and overall survival (OS) outcomes between those classified as VeriStrat-Poor and VeriStrat-Good.	3 years
Platinum-based therapy outcomes in VeriStrat Poor vs. Good subjects.	To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with platinum-based therapy.	3 years
Immunotherapy outcomes in VeriStrat Poor vs. Good subjects.	To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with immunotherapy.	3 years
Single agent chemotherapy outcomes in VeriStrat Poor vs. Good Subjects	To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with single agent chemotherapy.	3 years
VeriStrat label changes over time.	To compare the longitudinal changes in VeriStrat classification over the course of the study	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Immunotherapy tests ability to stratify subjects based on treatment.	To determine whether immunotherapy test(s) stratify subjects treated with chemotherapy or targeted therapies by outcome.	3 years
Correlation between the VeriStrat test and Immunotherapy tests.	To observe the correlation between VeriStrat classification and immunotherapy test(s) classification at baseline and longitudinally.	3 years
Longitudinal changes in Immunotherapy tests.	To describe the longitudinal changes in immunotherapy test classification over the course of the study.	3 years
Stratification of Immunotherapy Test(s)	To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by other clinically meaningful factors or endpoints.	3 years
Changes in GeneStrat	To observe changes in GeneStrat status across lines of therapy.	3 years

Collaborators and Investigators

• Sponsor: Biodesix, Inc.
• Investigators: Principal Investigator: Steve Springmeyer, MD, Biodesix, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• Rich P, Mitchell RB, Schaefer E, Walker PR, Dubay JW, Boyd J, Oubre D, Page R, Khalil M, Sinha S, Boniol S, Halawani H, Santos ES, Brenner W, Orsini JM, Pauli E, Goldberg J, Veatch A, Haut M, Ghabach B, Bidyasar S, Quejada M, Khan W, Huang K, Traylor L, Akerley W. Real-world performance of blood-based proteomic profiling in first-line immunotherapy treatment in advanced stage non-small cell lung cancer. J Immunother Cancer. 2021 Oct;9(10):e002989. doi: 10.1136/jitc-2021-002989.

Helpful Links

• Sponsor Website

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2016
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: BDX-00146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No