Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT03289780
- Lead Sponsor
- Biodesix, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5006
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method VeriStrat Poor vs. Good Outcomes 3 years To compare progression free survival (PFS) and overall survival (OS) outcomes between those classified as VeriStrat-Poor and VeriStrat-Good.
Immunotherapy Stratification by Overall Survival 3 years To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by overall survival.
Immunotherapy outcomes in VeriStrat Poor vs. Good subjects. 3 years To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with immunotherapy.
Single agent chemotherapy outcomes in VeriStrat Poor vs. Good Subjects 3 years To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with single agent chemotherapy.
VeriStrat label changes over time. 3 years To compare the longitudinal changes in VeriStrat classification over the course of the study
Immunotherapy Stratification by Progression-Free Survival 3 years To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by progression-free survival.
Platinum-based therapy outcomes in VeriStrat Poor vs. Good subjects. 3 years To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with platinum-based therapy.
Trial Locations
- Locations (42)
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
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