Clinical trial NCT06896162: PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
Official title: PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Solid Tumor Malignancies
Metastatic Cancer
Breast Cancer
Colorectal Cancer
Lung Cancer
Bladder Cancer
Keywords: next-generation sequencing (NGS)
expert review of NGS
precision oncology
precision oncology navigator
genome informed therapy (GIT)
biomarker-directed clinical trials
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2025-03-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: hybrid decentralized
Primary purpose: TREATMENT

Brief summary: This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid tumor malignancies (breast, lung, colorectal, and bladder cancers).

The purpose of this study is to investigate whether intervention from a centralized precision oncology navigator and expert review of NGS results by the precision oncology pharmacist will increase ordering of Level 1/2 genome informed therapy (GIT) compared to an estimated historical rate of 15%. Secondary endpoints will assess the impact of a centralized precision oncology navigator and expert review of NGS results on enrollment in biomarker-directed clinical trials and overall survival at 2 years after return of NGS results. The study will take approximately 12 months for enrolment and 2 years of follow-up after the date of NGS results.

Detailed description: Despite data supporting a survival benefit in many cancers, rates of NGS testing and subsequent GIT are reported to be low in real-world data sets. Rates of multigene panel-based testing and targeted therapy use are reported to be higher at NCI-designated cancer centers compared to other practice types, even when they are associated with a "hub" site. Molecular tumor boards have demonstrated improvements in overall survival in lung cancer, but these models rely on consults being placed by treating physicians and/or significant institutional resources. Many studies evaluating interventions to increase the use of genome informed therapy (GIT) focus on a single cancer type, thereby hindering the ability to operationalize supportive interventions broadly across all cancer types. Given the collective body of data supporting meaningful clinical improvements when patients have access to GIT, we want to study if interventions that make NGS test ordering and interpretation easier for clinicians will increase the rate of orders for GIT. The use of a centralized precision oncology navigator to facilitate completion of NGS testing, expert clinical review from a clinical pharmacist, and documented clinical decision support embedded in the electronic health record represents a unique and more easily scalable model than full molecular tumor board reviews.

Eligibility criteria: In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria

* Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.
* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
* Age ≥ 18 years at the time of consent.
* ECOG or Karnofsky Performance Status of 0-2.
* Documented Stage IV solid tumor malignancy: NSCLC, CRC, Breast or Bladder Cancer
* The treating provider deems Next Generation Sequencing (NGS) testing appropriate and plans to consider results in either first- or second-line therapy in the metastatic setting
* A genomic tumor test has not been ordered or has been ordered but not resulted.

Exclusion Criteria:

• Subjects with an active concurrent malignancy.

Primary outcomes:
measure: The rate of genome informed therapy (GIT) orders
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 2 years
measure: The rate of genome informed therapy (GIT) orders by site
timeFrame: 2 years
measure: The rates of consent to UNC Health biomarker-selective clinical trials
timeFrame: 2 years
measure: The reasons for non-consent
timeFrame: 2 years
measure: Overall Survival in subjects who are eligible for Level 1/2 genome-informed therapy (GIT)
timeFrame: 2 years
measure: The rates of referrals for full Molecular Tumor Board
timeFrame: 2 years
measure: The combined rate of orders for Level 1/2 GIT and consent to biomarker-directed clinical trials
timeFrame: 2 years
measure: The time between the date of NGS results and the Level 1/2 GIT order date
timeFrame: 2 years
measure: Reasons for lack of Level 1/2 GIT orders in eligible subjects
timeFrame: 2 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Carrie Lee
role: PRINCIPAL_INVESTIGATOR
References: