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

NCT03289780 · tracked via the Priya Life Science USA tracker

Sponsor

Biodesix, Inc.

Phase

Observational

Started

2016-04-04

Last updated

2025-09-19

Condition(s) studied

Non-Small Cell Lung Cancer

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Physician Treatment Patterns Description — 3 years
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.

Trial sites (42)

Facility	City	Region
Oncology Specialties, PC; Clearview Cancer Institute	Huntsville	Alabama
Lewis & Faye Manderson Cancer Center at DCH Regional Medical Center	Tuscaloosa	Alabama
Highlands Oncology Group	Fayetteville	Arkansas
St. Bernards Cancer Center Hematology / Oncology	Jonesboro	Arkansas
Valley Medical Oncology Consultants	Pleasanton	California
Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
Boca Raton Regional Hospital -Lynn Cancer Institute	Boca Raton	Florida
Lake City Cancer Care, LLC	Lake City	Florida
South Eastern Regional Medical Center	Newnan	Georgia
Summit Cancer Care	Savannah	Georgia
South Georgia Medical Center	Valdosta	Georgia
Edward-Elmhurst Healthcare	Naperville	Illinois
Illinois Cancer Care	Peoria	Illinois
Franciscan St. Francis Health	Indianapolis	Indiana
Franciscan Health Woodland Cancer Center	Michigan City	Indiana
Ponchartrain Cancer Center	Covington	Louisiana
Christus Health	Shreveport	Louisiana
North Mississippi Medical Center - Hematology and Oncology Clinic	Tupelo	Mississippi
Central Care Cancer Center	Bolivar	Missouri
Phelps County Regional Medical Center	Rolla	Missouri
Mercy Medical	Springfield	Missouri
Nebraska Methodist Hospital	Omaha	Nebraska
Essex Oncology	Belleville	New Jersey
New York Oncology Group	Albany	New York
Clinical Research Associates	Lake Success	New York
NYU Laura & Isaac Perlmutter Cancer Center	New York	New York
University of North Carolina	Chapel Hill	North Carolina
Southeastern Medical Oncology	Goldsboro	North Carolina
Leo W. Jenkins Cancer Center - East Carolina University	Greenville	North Carolina
Hematology and Oncology Associates - Mercy Medical Center	Canton	Ohio
Tri-County Hematology & Oncology Associates	Massillon	Ohio
Oregon Oncology Specialists (QCCA)	Salem	Oregon
Gettysburg Cancer Center	Gettysburg	Pennsylvania
Bon Secours St. Francis Cancer Center	Greenville	South Carolina
Arlington Cancer Center	Arlington	Texas
JPS Health Network, JPS Center for Cancer Care	Fort Worth	Texas
The Center for Cancer and Blood Disorders	Fort Worth	Texas
Scott & White Memorial Hospital and Clinic	Temple	Texas
Huntsman Cancer Institute	Salt Lake City	Utah
Virginia Cancer Institute	Richmond	Virginia

+ 2 more sites — see the full list on the official registry below.

More Biodesix, Inc. trials in the USA

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Other trials for the same condition

A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting

A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors Active, not recruiting

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation Recruiting

Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor Active, not recruiting

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03289780 on ClinicalTrials.gov ↗ ← All trials in the USA