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

Running, not enrolling

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03289780

Run by

Biodesix, Inc.

People needed

5006

Starts

2016-04-04

Expected to finish

2025-12-01

Last updated by the study team

2025-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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