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Non-Small Cell Lung CancerINSIGHTNCT03289780

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

An observational study of Non-Small Cell Lung Cancer, run by Biodesix, Inc. at 42 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
How many people
5,006 participants
Where
42 sitesUnited States
Study dates
4 Apr 2016to Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Any Subject with Non-Small Cell Lung Cancer (NSCLC) at all stages with any histology.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • New York Oncology Group

    Albany, New York, 12206

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Essex Oncology

    Belleville, New Jersey, 07109

  • Peace Health

    Bellingham, Washington, 982256

  • Boca Raton Regional Hospital -Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Central Care Cancer Center

    Bolivar, Missouri, 65613

  • Hematology and Oncology Associates - Mercy Medical Center

    Canton, Ohio, 44708

  • University of North Carolina

    Chapel Hill, North Carolina, 27517

  • Ponchartrain Cancer Center

    Covington, Louisiana, 70433

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • JPS Health Network, JPS Center for Cancer Care

    Fort Worth, Texas, 76104

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Southeastern Medical Oncology

    Goldsboro, North Carolina, 27534

  • Leo W. Jenkins Cancer Center - East Carolina University

    Greenville, North Carolina, 27834

  • Bon Secours St. Francis Cancer Center

    Greenville, South Carolina, 29607

  • Oncology Specialties, PC; Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • St. Bernards Cancer Center Hematology / Oncology

    Jonesboro, Arkansas, 72401

  • Lake City Cancer Care, LLC

    Lake City, Florida, 32024

  • Clinical Research Associates

    Lake Success, New York, 11042

  • Tri-County Hematology & Oncology Associates

    Massillon, Ohio, 44646

  • Franciscan Health Woodland Cancer Center

    Michigan City, Indiana, 46360

  • Edward-Elmhurst Healthcare

    Naperville, Illinois, 60540

  • NYU Laura & Isaac Perlmutter Cancer Center

    New York, New York, 10016

  • South Eastern Regional Medical Center

    Newnan, Georgia, 30265

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Phelps County Regional Medical Center

    Rolla, Missouri, 65401

  • Oregon Oncology Specialists (QCCA)

    Salem, Oregon, 97301

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Summit Cancer Care

    Savannah, Georgia, 31405

  • Christus Health

    Shreveport, Louisiana, 71105

  • Mercy Medical

    Springfield, Missouri, 65804

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Scott & White Memorial Hospital and Clinic

    Temple, Texas, 76508

  • North Mississippi Medical Center - Hematology and Oncology Clinic

    Tupelo, Mississippi, 38801

  • Lewis & Faye Manderson Cancer Center at DCH Regional Medical Center

    Tuscaloosa, Alabama, 35401

  • South Georgia Medical Center

    Valdosta, Georgia, 31602

Other trials in United States

About this study

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

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.

Read the 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.

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

Secondary outcomes (7)

  1. Immunotherapy Stratification by Overall Survival

    To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by overall survival.

    Measured: 3 years

  2. Immunotherapy Stratification by Progression-Free Survival

    To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by progression-free survival.

    Measured: 3 years

  3. 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.

    Measured: 3 years

  4. 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.

    Measured: 3 years

  5. Immunotherapy outcomes in VeriStrat Poor vs. Good subjects.

    To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with immunotherapy.

    Measured: 3 years

  6. 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.

    Measured: 3 years

  7. VeriStrat label changes over time.

    To compare the longitudinal changes in VeriStrat classification over the course of the study

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2017
  2. Study start4 Apr 2016
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,006 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03289780
Sponsor's protocol ID
BDX-00146
Acronym
INSIGHT
Status last verified
Sep 2025
First submitted
16 Aug 2017
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28277859

  • 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.

    PubMed 27898657

  • 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.

    PubMed 34706885

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Small Cell Lung Cancer, run by Biodesix, Inc. at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physician Treatment Patterns Description (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03289780, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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