Non Small Cell Lung CancerNCT05603299
Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Venn Biosciences' Dawn Test
A study testing Educational Materials on the Dawn test in people with Non Small Cell Lung Cancer, run by Qure Healthcare, LLC.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Educational Materials on the Dawn test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Jun 2023to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- English speaking
- Access to the internet
- Informed, signed, and voluntarily consented to be in the study
Who cannot join
- 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
About this study
Official title: Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Venn Biosciences' DawnTM: A CPV® Randomized Controlled Trial
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.
Read the 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
- Being tested
- Educational Materials on the Dawn test
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Materials on the Dawn testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The Control group treats their simulated patients using standard practice and have no introduction to the new test. |
| Intervention Group 1 - Test Results Given | Experimental | Receiving educational materials describing the clinical validation and use cases of a predefined Dawn™ test and is given specific Dawn™ test results in Round 2 of CPV administration, whether they order the test or not. Receives: Other: Educational Materials on the Dawn test |
| Intervention Group 2 - Test Results Optional | Experimental | Receiving educational materials describing the clinical validation and use cases of a predefined Dawn™ test and is given specific Dawn™ test results in Round 2 of CPV administration, only if they choose to order the test. Receives: Other: Educational Materials on the Dawn test |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPV-measured clinical score difference
Pre- and post-difference in the overall and the diagnostic and treatment quality scores between control physicians using standard of care diagnostic tools and intervention physicians using the Dawn™ test. In each CPV, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes. The investigators will measure the overall change in the evidence-based physician behavior including physical exam, workup, diagnosis, and treatment of lung cancer in the CPV patient simulations.
Measured: [6 months]
CPV-measured cost difference
Change in cost of related care for patients with lung cancer when comparing the control to the intervention group. (This cost is modeled in part by measuring differential rates of medical interventions selected by each arm and multiplying by average Medicare reimbursement rates for these interventions. The cost is also modeled by examining average per annum costs for patients suffering from lung cancer and multiplying by the percent of patients whose workup and interventions for cancer risks are significantly reduced following the intervention.)
Measured: [6 months]
Secondary outcomes (2)
CPV-measured baseline clinical variation levels
Participants completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess the baseline levels of variation in the care of pain patients among all participants, including by use case types. The investigators will measure the baseline levels of variation in the assessment, recognition, and management of lung cancer among all participants.
Measured: [6 months]
CPV-measured assessment of use case types
The difference in the overall, and the diagnostic and treatment quality scores between control and intervention participants. Diagnostic and treatment scores are calculated as the percent correct on CPVs, and the overall score is an average score of the subcategory scores (percent correct). This will be examined for each of the use cases to determine in which case(s) CPV scores most improved.
Measured: [6 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start21 Jun 2023 (estimated)
- Primary completion18 Dec 2023 (estimated)
- Study completion18 Dec 2023 (estimated)
Why it stopped: The study recruited no participants due to a pre-recruitment decision by the sponsor to not proceed. Factors considered included logistics, resources, and new research data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Venn Biosciences Corporation
- Responsible party
- Sponsor
- Investigators
- John W Peabody, MD, PhD, Principal investigator, QURE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603299
- Sponsor's protocol ID
- Pro00062590
- Status last verified
- Jun 2023
- First submitted
- 28 Oct 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for Venn Biosciences' DawnTM: A CPV® Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05603299
- Acronym / sponsor ID
- Pro00062590
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study recruited no participants due to a pre-recruitment decision by the sponsor to not proceed. Factors considered included logistics, resources, and new research data.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Venn Biosciences Corporation
- Study start
- 21 Jun 2023 (estimated)
- Primary completion
- 18 Dec 2023 (estimated)
- Study completion
- 18 Dec 2023 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The Control group treats their simulated patients using standard practice and have no introduction to the new test. |
| Intervention Group 1 - Test Results Given | Experimental | Other: Educational Materials on the Dawn testReceiving educational materials describing the clinical validation and use cases of a predefined Dawn™ test and is given specific Dawn™ test results in Round 2 of CPV administration, whether they order the test or not. |
| Intervention Group 2 - Test Results Optional | Experimental | Other: Educational Materials on the Dawn testReceiving educational materials describing the clinical validation and use cases of a predefined Dawn™ test and is given specific Dawn™ test results in Round 2 of CPV administration, only if they choose to order the test. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Materials on the Dawn testReceive 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. | Other | Intervention Group 1 - Test Results Given, Intervention Group 2 - Test Results Optional |
Primary outcome
CPV-measured clinical score difference
Time frame: [6 months]
Pre- and post-difference in the overall and the diagnostic and treatment quality scores between control physicians using standard of care diagnostic tools and intervention physicians using the Dawn™ test. In each CPV, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes. The investigators will measure the overall change in the evidence-based physician behavior including physical exam, workup, diagnosis, and treatment of lung cancer in the CPV patient simulations.
CPV-measured cost difference
Time frame: [6 months]
Change in cost of related care for patients with lung cancer when comparing the control to the intervention group. (This cost is modeled in part by measuring differential rates of medical interventions selected by each arm and multiplying by average Medicare reimbursement rates for these interventions. The cost is also modeled by examining average per annum costs for patients suffering from lung cancer and multiplying by the percent of patients whose workup and interventions for cancer risks are significantly reduced following the intervention.)
2 secondary outcomes
CPV-measured baseline clinical variation levels
Time frame: [6 months]
CPV-measured assessment of use case types
Time frame: [6 months]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Peabody, MD, PhD principal investigator
QURE Healthcare
Questions about this trial
What is this clinical trial studying?
A study testing Educational Materials on the Dawn test in people with Non Small Cell Lung Cancer, run by Qure Healthcare, LLC.
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 9 inclusion and 6 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: withdrawn, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
CPV-measured clinical score difference (time frame: [6 months]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2023.