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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects With Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunotherapy Stratification by Overall Survival | To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by overall survival. | 3 years | 
| Immunotherapy Stratification by Progression-Free Survival | To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by progression-free survival. | 3 years | 
| VeriStrat Poor vs. Good Outcomes | To compare progression free survival (PFS) and overall survival (OS) outcomes between those classified as VeriStrat-Poor and VeriStrat-Good. | 3 years | 
| Platinum-based therapy outcomes in VeriStrat Poor vs. Good subjects. | To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with platinum-based therapy. | 3 years | 
| Immunotherapy outcomes in VeriStrat Poor vs. Good subjects. | To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with immunotherapy. | 3 years | 
| Single agent chemotherapy outcomes in VeriStrat Poor vs. Good Subjects | To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with single agent chemotherapy. | 3 years | 
| VeriStrat label changes over time. | To compare the longitudinal changes in VeriStrat classification over the course of the study | 3 years |