Clinical trial NCT05603299: Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Venn Biosciences' Dawn Test
Official title: Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Venn Biosciences' DawnTM: A CPV® Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
Collaborators: name: Venn Biosciences Corporation
First posted: 2022-11-02
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: QURE will use its CPV technology in a randomized controlled trial to measure how InterVenn Biosciences diagnostic test changes clinical practice and improves patient outcomes.

Detailed description: VennBio has developed a pioneering technology, Dawn™, a semi-quantitative assay using ultra-high-pressure-liquid chromatography, quantitative mass spectrometry (MS) that predicts the likelihood of a benefit from pembrolizumab (Keytruda®) or nivolumab (Opdivo®) plus ipilimumab (Yervoy®)), three of the most widely used immune checkpoint inhibitors currently available in the market. The Company's technology is powered by glycoproteomics and artificial intelligence (AI). The AI allows measuring of the glycoproteins and biological makeup of a patient. This combination of technology is meant for physicians to make the best decisions for patient outcomes in immuno-oncology (IO) therapies.

VennBio hopes to make Dawn™'s glycoproteomic solution widely available and is looking to accelerate the adoption of the test in patients with advanced/metastatic NSCLC. To make the test available to more patients, VennBio is looking for established, innovative approaches to gather high-quality prospective clinical utility data quickly. These data will be essential to increase access to the test and to gain coverage and reimbursement.

Accordingly, the proposed study will collect high-quality randomized controlled data from a nationally representative sample of practicing medical oncologists. The primary purposes of this study will be to 1) determine how these physicians currently choose therapy for advanced (i.e., locally advanced, unresectable, or metastatic) NSCLC patients, 2) ascertain if introducing the Dawn™ test will improve clinical decision-making, and 3) observe how the educational materials affect physician uptake of the Dawn™ test and treatment of their patients, particularly in assigning immunotherapy (e.g., IO monotherapy vs combination treatment with chemotherapy). Data from this study will investigate the best use case (type of patient) optimally served by Dawn™ testing (and thus the greatest clinical utility) and what physician characteristics (e.g., age, practice setting, training) and practice characteristics (e.g., multi-specialty, private practice, etc.) are associated with these practice changes.

QURE Healthcare is a team of clinicians and researchers that conducts randomized-controlled trials using Clinical Performance and Value (CPV®) patient simulations to generate high-quality clinical utility evidence. CPVs are QURE's scientifically-validated measurement tool, first described in the Journal of American Medical Association (JAMA) in 2000 and now used in scores of scientific investigations. In this research and derivative peer-reviewed publications, QURE's CPV studies efficiently measure clinical practice patterns among active physicians to determine if there is the value of new technologies to payers.

Eligibility criteria: Inclusion Criteria:

* Board-certified medical oncologists for at least two years
* Averaging at least 20 hours per week of clinical and patient care duties over the last six months
* Routinely evaluate patients with advanced/metastatic NSCLC in their practice
* Prescribe IO therapies for their advanced/metastatic NSCLC patients
* Practice in either an academic, non-academic, or network hospital setting
* Practicing in the U.S.
* English speaking
* Access to the internet
* Informed, signed, and voluntarily consented to be in the study

Exclusion Criteria:

* Not board-certified in oncology
* Not English speaking
* Not averaging at least 20 hours per week of clinical and patient care duties over the last six months
* Not practicing in the U.S.
* No access to the internet
* Did not voluntarily consent to be in the study

Primary outcomes:
measure: CPV-measured clinical score difference
timeFrame: [6 months]
measure: CPV-measured cost difference
timeFrame: [6 months]
Secondary outcomes:
measure: CPV-measured baseline clinical variation levels
timeFrame: [6 months]
measure: CPV-measured assessment of use case types
timeFrame: [6 months]
Other outcomes:
Locations:
Study officials:
affiliation: QURE Healthcare
name: John W Peabody, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: