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

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ClinicalTrials.gov Identifier: NCT03289780
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Biodesix, Inc.

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.

Condition or disease
Non-Small Cell Lung Cancer

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.


Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects With Non-Small Cell Lung Cancer
Actual Study Start Date : April 4, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Physician Treatment Patterns Description [ Time Frame: 18 months ]
    1. 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.


Secondary Outcome Measures :
  1. Immunotherapy Stratification by Overall Survival [ Time Frame: 18 month ]
    To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by overall survival.

  2. Immunotherapy Stratification by Progression-Free Survival [ Time Frame: 18 months ]
    To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by progression-free survival.

  3. VeriStrat Poor vs. Good Outcomes [ Time Frame: 18 months ]
    To compare progression free survival (PFS) and overall survival (OS) outcomes between those classified as VeriStrat-Poor and VeriStrat-Good.

  4. Platinum-based therapy outcomes in VeriStrat Poor vs. Good subjects. [ Time Frame: 18 months ]
    To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with platinum-based therapy.

  5. Immunotherapy outcomes in VeriStrat Poor vs. Good subjects. [ Time Frame: 18 months ]
    To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with immunotherapy.

  6. Gemcitabine outcomes in VeriStrat Poor vs. Good Subjects [ Time Frame: 18 months ]
    To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with gemcitabine.

  7. VeriStrat label changes over time. [ Time Frame: 18 months ]
    To compare the longitudinal changes in VeriStrat classification over the course of the study


Other Outcome Measures:
  1. Determination of Immunotherapy tests ability to stratify subjects based on treatment. [ Time Frame: 18 months ]
    To compare progression free survival (PFS) and overall survival (OS) outcomes in patients as stratified by the immunotherapy test(s) treated with chemotherapy or targeted therapies.

  2. Correlation between the VeriStrat test and Immunotherapy tests. [ Time Frame: 18 months ]
    To observe the correlation between VeriStrat classification and immunotherapy test(s) classification at baseline and longitudinally.

  3. Longitudinal changes in Immunotherapy tests. [ Time Frame: 18 months ]
    To describe the longitudinal changes in immunotherapy test classification over the course of the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any Subject with Non-Small Cell Lung Cancer (NSCLC) at all stages with any histology.
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. EGFR mutation status wildtype or unknown.
  4. Subject is willing to provide serum samples for VeriStrat testing.
  5. For subjects with UNKNOWN EGFR status only: The subject must be willing to provide plasma 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. If subject has had prior treatment for local disease, disease progression was documented and treatment was completed prior to VeriStrat testing.
  8. Subject is able to read and understand the ICF, and agrees to comply with study procedures and requirements.

Exclusion Criteria:

  1. History of prior malignancy within 2 years of signing ICF (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early stage prostate cancer, without evidence of recurrence).
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289780


Contacts
Contact: Niki Givens, B.S. 720-495-1583 niki.givens@biodesix.com
Contact: Alix Arnaud, M.S 720-509-8845 alix.arnaud@biodesix.com

  Show 28 Study Locations
Sponsors and Collaborators
Biodesix, Inc.
Investigators
Principal Investigator: Linda Traylor, Ph.D Biodesix, Inc.
  Study Documents (Full-Text)

Documents provided by Biodesix, Inc.:
Study Protocol  [PDF] March 20, 2017
Informed Consent Form  [PDF] March 20, 2017


Additional Information:
Publications:
Responsible Party: Biodesix, Inc.
ClinicalTrials.gov Identifier: NCT03289780     History of Changes
Other Study ID Numbers: BDX-00146
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms