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
1 other identifier
observational
5,006
1 country
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2016
CompletedFirst Submitted
Initial submission to the registry
August 16, 2017
CompletedFirst Posted
Study publicly available on registry
September 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedSeptember 19, 2025
September 1, 2025
9.7 years
August 16, 2017
September 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Immunotherapy Stratification by Overall Survival
3 years
Immunotherapy Stratification by Progression-Free Survival
3 years
VeriStrat Poor vs. Good Outcomes
3 years
Platinum-based therapy outcomes in VeriStrat Poor vs. Good subjects.
3 years
Immunotherapy outcomes in VeriStrat Poor vs. Good subjects.
3 years
- +2 more secondary outcomes
Other Outcomes (5)
Determination of Immunotherapy tests ability to stratify subjects based on treatment.
3 years
Correlation between the VeriStrat test and Immunotherapy tests.
3 years
Longitudinal changes in Immunotherapy tests.
3 years
- +2 more other outcomes
Eligibility Criteria
Any Subject with Non-Small Cell Lung Cancer (NSCLC) at all stages with any histology.
You may qualify if:
- Subject must be 18 years of age or older at time of signing informed consent form (ICF).
- A diagnosis of NSCLC.
- Subject is willing to provide serum samples for VeriStrat testing.
- EGFR mutation status wild-type (negative) or a tested unknown.
- For subjects with untested/unknown EGFR status only: The subject must be willing to provide blood samples for GeneStrat testing.
- 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.
- Subject is able to read and understand the ICF and agrees to comply with study procedures and requirements.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biodesix, Inc.lead
Study Sites (42)
Oncology Specialties, PC; Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Lewis & Faye Manderson Cancer Center at DCH Regional Medical Center
Tuscaloosa, Alabama, 35401, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
St. Bernards Cancer Center Hematology / Oncology
Jonesboro, Arkansas, 72401, United States
Valley Medical Oncology Consultants
Pleasanton, California, 94588, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
Boca Raton Regional Hospital -Lynn Cancer Institute
Boca Raton, Florida, 33486, United States
Lake City Cancer Care, LLC
Lake City, Florida, 32024, United States
South Eastern Regional Medical Center
Newnan, Georgia, 30265, United States
Summit Cancer Care
Savannah, Georgia, 31405, United States
South Georgia Medical Center
Valdosta, Georgia, 31602, United States
Edward-Elmhurst Healthcare
Naperville, Illinois, 60540, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Franciscan St. Francis Health
Indianapolis, Indiana, 46237, United States
Franciscan Health Woodland Cancer Center
Michigan City, Indiana, 46360, United States
Ponchartrain Cancer Center
Covington, Louisiana, 70433, United States
Christus Health
Shreveport, Louisiana, 71105, United States
North Mississippi Medical Center - Hematology and Oncology Clinic
Tupelo, Mississippi, 38801, United States
Central Care Cancer Center
Bolivar, Missouri, 65613, United States
Phelps County Regional Medical Center
Rolla, Missouri, 65401, United States
Mercy Medical
Springfield, Missouri, 65804, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Essex Oncology
Belleville, New Jersey, 07109, United States
New York Oncology Group
Albany, New York, 12206, United States
Clinical Research Associates
Lake Success, New York, 11042, United States
NYU Laura & Isaac Perlmutter Cancer Center
New York, New York, 10016, United States
University of North Carolina
Chapel Hill, North Carolina, 27517, United States
Southeastern Medical Oncology
Goldsboro, North Carolina, 27534, United States
Leo W. Jenkins Cancer Center - East Carolina University
Greenville, North Carolina, 27834, United States
Hematology and Oncology Associates - Mercy Medical Center
Canton, Ohio, 44708, United States
Tri-County Hematology & Oncology Associates
Massillon, Ohio, 44646, United States
Oregon Oncology Specialists (QCCA)
Salem, Oregon, 97301, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Bon Secours St. Francis Cancer Center
Greenville, South Carolina, 29607, United States
Arlington Cancer Center
Arlington, Texas, 76012, United States
JPS Health Network, JPS Center for Cancer Care
Fort Worth, Texas, 76104, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Scott & White Memorial Hospital and Clinic
Temple, Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Peace Health
Bellingham, Washington, 982256, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
Related Publications (3)
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: 28277859BACKGROUNDGrossi 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: 27898657BACKGROUNDRich 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.
PMID: 34706885DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steve Springmeyer, MD
Biodesix, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2017
First Posted
September 21, 2017
Study Start
April 4, 2016
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share