NCT05603299

Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Venn Biosciences' Dawn Test

Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Venn Biosciences' DawnTM: A CPV® Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Qure Healthcare, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Educational Materials on the Dawn test	Receive educational materials and sample test results replicating what physicians would receive in the real-world market as they learn about the probability of IO therapy response from the Dawn™ test.

Timeline

• Start date: 2023-06-21
• Primary completion: 2023-12-18
• Completion: 2023-12-18
• First posted: 2022-11-02
• Last updated: 2023-06-15