Clinical trial NCT03289780: Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects
Official title: An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects With Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Biodesix, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-21
Enrollment: 5006
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any Subject with Non-Small Cell Lung Cancer (NSCLC) at all stages with any histology.

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.

Eligibility criteria: 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 outcomes:
measure: Physician Treatment Patterns Description
timeFrame: 3 years
Secondary outcomes:
measure: Immunotherapy Stratification by Overall Survival
timeFrame: 3 years
measure: Immunotherapy Stratification by Progression-Free Survival
timeFrame: 3 years
measure: VeriStrat Poor vs. Good Outcomes
timeFrame: 3 years
measure: Platinum-based therapy outcomes in VeriStrat Poor vs. Good subjects.
timeFrame: 3 years
measure: Immunotherapy outcomes in VeriStrat Poor vs. Good subjects.
timeFrame: 3 years
measure: Single agent chemotherapy outcomes in VeriStrat Poor vs. Good Subjects
timeFrame: 3 years
measure: VeriStrat label changes over time.
timeFrame: 3 years
Other outcomes:
measure: Determination of Immunotherapy tests ability to stratify subjects based on treatment.
timeFrame: 3 years
measure: Correlation between the VeriStrat test and Immunotherapy tests.
timeFrame: 3 years
measure: Longitudinal changes in Immunotherapy tests.
timeFrame: 3 years
measure: Stratification of Immunotherapy Test(s)
timeFrame: 3 years
measure: Changes in GeneStrat
timeFrame: 3 years
Locations:
city: Huntsville
country: United States
facility: Oncology Specialties, PC; Clearview Cancer Institute
state: Alabama
city: Tuscaloosa
country: United States
facility: Lewis & Faye Manderson Cancer Center at DCH Regional Medical Center
state: Alabama
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Jonesboro
country: United States
facility: St. Bernards Cancer Center Hematology / Oncology
state: Arkansas
city: Pleasanton
country: United States
facility: Valley Medical Oncology Consultants
state: California
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Associates
state: Connecticut
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital -Lynn Cancer Institute
state: Florida
city: Lake City
country: United States
facility: Lake City Cancer Care, LLC
state: Florida
city: Newnan
country: United States
facility: South Eastern Regional Medical Center
state: Georgia
city: Savannah
country: United States
facility: Summit Cancer Care
state: Georgia
city: Valdosta
country: United States
facility: South Georgia Medical Center
state: Georgia
city: Naperville
country: United States
facility: Edward-Elmhurst Healthcare
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Michigan City
country: United States
facility: Franciscan Health Woodland Cancer Center
state: Indiana
city: Covington
country: United States
facility: Ponchartrain Cancer Center
state: Louisiana
city: Shreveport
country: United States
facility: Christus Health
state: Louisiana
city: Tupelo
country: United States
facility: North Mississippi Medical Center - Hematology and Oncology Clinic
state: Mississippi
city: Bolivar
country: United States
facility: Central Care Cancer Center
state: Missouri
city: Rolla
country: United States
facility: Phelps County Regional Medical Center
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Belleville
country: United States
facility: Essex Oncology
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Group
state: New York
city: Lake Success
country: United States
facility: Clinical Research Associates
state: New York
city: New York
country: United States
facility: NYU Laura & Isaac Perlmutter Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology
state: North Carolina
city: Greenville
country: United States
facility: Leo W. Jenkins Cancer Center - East Carolina University
state: North Carolina
city: Canton
country: United States
facility: Hematology and Oncology Associates - Mercy Medical Center
state: Ohio
city: Massillon
country: United States
facility: Tri-County Hematology & Oncology Associates
state: Ohio
city: Salem
country: United States
facility: Oregon Oncology Specialists (QCCA)
state: Oregon
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Bon Secours St. Francis Cancer Center
state: South Carolina
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: JPS Health Network, JPS Center for Cancer Care
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital and Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Bellingham
country: United States
facility: Peace Health
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
Study officials:
affiliation: Biodesix, Inc.
name: Steve Springmeyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.