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

Non-Small Cell Lung Cancer Clinical Trial

— INSIGHT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03289780
• Other study ID #: BDX-00146
• Status: Active, not recruiting
• Start date: April 4, 2016
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Biodesix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 5006
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
United States	New York Oncology Group	Albany	New York
United States	Arlington Cancer Center	Arlington	Texas
United States	Essex Oncology	Belleville	New Jersey
United States	Peace Health	Bellingham	Washington
United States	Boca Raton Regional Hospital -Lynn Cancer Institute	Boca Raton	Florida
United States	Central Care Cancer Center	Bolivar	Missouri
United States	Hematology and Oncology Associates - Mercy Medical Center	Canton	Ohio
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Ponchartrain Cancer Center	Covington	Louisiana
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	JPS Health Network, JPS Center for Cancer Care	Fort Worth	Texas
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	Southeastern Medical Oncology	Goldsboro	North Carolina
United States	Bon Secours St. Francis Cancer Center	Greenville	South Carolina
United States	Leo W. Jenkins Cancer Center - East Carolina University	Greenville	North Carolina
United States	Oncology Specialties, PC; Clearview Cancer Institute	Huntsville	Alabama
United States	Franciscan St. Francis Health	Indianapolis	Indiana
United States	St. Bernards Cancer Center Hematology / Oncology	Jonesboro	Arkansas
United States	Lake City Cancer Care, LLC	Lake City	Florida
United States	Clinical Research Associates	Lake Success	New York
United States	Tri-County Hematology & Oncology Associates	Massillon	Ohio
United States	Franciscan Health Woodland Cancer Center	Michigan City	Indiana
United States	Edward-Elmhurst Healthcare	Naperville	Illinois
United States	NYU Laura & Isaac Perlmutter Cancer Center	New York	New York
United States	South Eastern Regional Medical Center	Newnan	Georgia
United States	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Illinois Cancer Care	Peoria	Illinois
United States	Valley Medical Oncology Consultants	Pleasanton	California
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Phelps County Regional Medical Center	Rolla	Missouri
United States	Oregon Oncology Specialists (QCCA)	Salem	Oregon
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Summit Cancer Care	Savannah	Georgia
United States	Christus Health	Shreveport	Louisiana
United States	Mercy Medical	Springfield	Missouri
United States	Northwest Medical Specialties, PLLC	Tacoma	Washington
United States	Scott & White Memorial Hospital and Clinic	Temple	Texas
United States	North Mississippi Medical Center - Hematology and Oncology Clinic	Tupelo	Mississippi
United States	Lewis & Faye Manderson Cancer Center at DCH Regional Medical Center	Tuscaloosa	Alabama
United States	South Georgia Medical Center	Valdosta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Biodesix, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Correlation between the VeriStrat test and Immunotherapy tests.	To observe the correlation between VeriStrat classification and immunotherapy test(s) classification at baseline and longitudinally.	3 years
Other	Longitudinal changes in Immunotherapy tests.	To describe the longitudinal changes in immunotherapy test classification over the course of the study.	3 years
Other	Stratification of Immunotherapy Test(s)	To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by other clinically meaningful factors or endpoints.	3 years
Other	Changes in GeneStrat	To observe changes in GeneStrat status across lines of therapy.	3 years
Primary	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	Immunotherapy Stratification by Overall Survival	To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by overall survival.	3 years
Secondary	Immunotherapy Stratification by Progression-Free Survival	To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by progression-free survival.	3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	VeriStrat label changes over time.	To compare the longitudinal changes in VeriStrat classification over the course of the study	3 years

External Links

•   Sponsor Website