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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.
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.
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Immunotherapy tests ability to stratify subjects based on treatment. | To determine whether immunotherapy test(s) stratify subjects treated with chemotherapy or targeted therapies by outcome. | 3 years |
| Correlation between the VeriStrat test and Immunotherapy tests. |
Inclusion Criteria:
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.
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Any Subject with Non-Small Cell Lung Cancer (NSCLC) at all stages with any histology.
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| Name | Affiliation | Role |
|---|---|---|
| Steve Springmeyer, MD | Biodesix, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Specialties, PC; Clearview Cancer Institute | Huntsville | Alabama | 35805 | United States | ||
| Lewis & Faye Manderson Cancer Center at DCH Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28277859 | Background | 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. | |
| 27898657 | Background | 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. |
| Label | URL |
|---|---|
| Sponsor Website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2017 | Jan 10, 2018 |
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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 |
To observe the correlation between VeriStrat classification and immunotherapy test(s) classification at baseline and longitudinally. |
| 3 years |
| Longitudinal changes in Immunotherapy tests. | To describe the longitudinal changes in immunotherapy test classification over the course of the study. | 3 years |
| Stratification of Immunotherapy Test(s) | To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by other clinically meaningful factors or endpoints. | 3 years |
| Changes in GeneStrat | To observe changes in GeneStrat status across lines of therapy. | 3 years |
| Tuscaloosa |
| Alabama |
| 35401 |
| United States |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States |
| St. Bernards Cancer Center Hematology / Oncology | Jonesboro | Arkansas | 72401 | United States |
| Valley Medical Oncology Consultants | Pleasanton | California | 94588 | United States |
| Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut | 06360 | United States |
| Boca Raton Regional Hospital -Lynn Cancer Institute | Boca Raton | Florida | 33486 | United States |
| Lake City Cancer Care, LLC | Lake City | Florida | 32024 | United States |
| South Eastern Regional Medical Center | Newnan | Georgia | 30265 | United States |
| Summit Cancer Care | Savannah | Georgia | 31405 | United States |
| South Georgia Medical Center | Valdosta | Georgia | 31602 | United States |
| Edward-Elmhurst Healthcare | Naperville | Illinois | 60540 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| Franciscan St. Francis Health | Indianapolis | Indiana | 46237 | United States |
| Franciscan Health Woodland Cancer Center | Michigan City | Indiana | 46360 | United States |
| Ponchartrain Cancer Center | Covington | Louisiana | 70433 | United States |
| Christus Health | Shreveport | Louisiana | 71105 | United States |
| North Mississippi Medical Center - Hematology and Oncology Clinic | Tupelo | Mississippi | 38801 | United States |
| Central Care Cancer Center | Bolivar | Missouri | 65613 | United States |
| Phelps County Regional Medical Center | Rolla | Missouri | 65401 | United States |
| Mercy Medical | Springfield | Missouri | 65804 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Essex Oncology | Belleville | New Jersey | 07109 | United States |
| New York Oncology Group | Albany | New York | 12206 | United States |
| Clinical Research Associates | Lake Success | New York | 11042 | United States |
| NYU Laura & Isaac Perlmutter Cancer Center | New York | New York | 10016 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27517 | United States |
| Southeastern Medical Oncology | Goldsboro | North Carolina | 27534 | United States |
| Leo W. Jenkins Cancer Center - East Carolina University | Greenville | North Carolina | 27834 | United States |
| Hematology and Oncology Associates - Mercy Medical Center | Canton | Ohio | 44708 | United States |
| Tri-County Hematology & Oncology Associates | Massillon | Ohio | 44646 | United States |
| Oregon Oncology Specialists (QCCA) | Salem | Oregon | 97301 | United States |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Bon Secours St. Francis Cancer Center | Greenville | South Carolina | 29607 | United States |
| Arlington Cancer Center | Arlington | Texas | 76012 | United States |
| JPS Health Network, JPS Center for Cancer Care | Fort Worth | Texas | 76104 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Scott & White Memorial Hospital and Clinic | Temple | Texas | 76508 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | United States |
| Peace Health | Bellingham | Washington | 982256 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| 34706885 | Derived | 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. |
| Prot_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 18, 2017 | Jan 10, 2018 | ICF_002.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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