Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects
NCT ID: NCT03289780
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
5006 participants
OBSERVATIONAL
2016-04-04
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.
NCT01652469
Biomarkers in Predicting Treatment Response in Samples From Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy
NCT01595074
Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers
NCT02785952
Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer
NCT00040794
A Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer
NCT06800339
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biodesix, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steve Springmeyer, MD
Role: PRINCIPAL_INVESTIGATOR
Biodesix, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oncology Specialties, PC; Clearview Cancer Institute
Huntsville, Alabama, United States
Lewis & Faye Manderson Cancer Center at DCH Regional Medical Center
Tuscaloosa, Alabama, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
St. Bernards Cancer Center Hematology / Oncology
Jonesboro, Arkansas, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Boca Raton Regional Hospital -Lynn Cancer Institute
Boca Raton, Florida, United States
Lake City Cancer Care, LLC
Lake City, Florida, United States
South Eastern Regional Medical Center
Newnan, Georgia, United States
Summit Cancer Care
Savannah, Georgia, United States
South Georgia Medical Center
Valdosta, Georgia, United States
Edward-Elmhurst Healthcare
Naperville, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
Franciscan Health Woodland Cancer Center
Michigan City, Indiana, United States
Ponchartrain Cancer Center
Covington, Louisiana, United States
Christus Health
Shreveport, Louisiana, United States
North Mississippi Medical Center - Hematology and Oncology Clinic
Tupelo, Mississippi, United States
Central Care Cancer Center
Bolivar, Missouri, United States
Phelps County Regional Medical Center
Rolla, Missouri, United States
Mercy Medical
Springfield, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Essex Oncology
Belleville, New Jersey, United States
New York Oncology Group
Albany, New York, United States
Clinical Research Associates
Lake Success, New York, United States
NYU Laura & Isaac Perlmutter Cancer Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Southeastern Medical Oncology
Goldsboro, North Carolina, United States
Leo W. Jenkins Cancer Center - East Carolina University
Greenville, North Carolina, United States
Hematology and Oncology Associates - Mercy Medical Center
Canton, Ohio, United States
Tri-County Hematology & Oncology Associates
Massillon, Ohio, United States
Oregon Oncology Specialists (QCCA)
Salem, Oregon, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
Bon Secours St. Francis Cancer Center
Greenville, South Carolina, United States
Arlington Cancer Center
Arlington, Texas, United States
JPS Health Network, JPS Center for Cancer Care
Fort Worth, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Scott & White Memorial Hospital and Clinic
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Peace Health
Bellingham, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Sponsor Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BDX-00146
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.