PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival

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.

NCT Number	NCT06896162
Lead Sponsor	UNC Lineberger Comprehensive Cancer Center Collaborators: Eli Lilly and Company
Conditions	Solid Tumor Malignancies, Metastatic Cancer, Breast Cancer, Colorectal Cancer, Lung Cancer, Bladder Cancer
Enrollment	500 participants
Start Date	2025-06-27
Primary Completion	2028-06 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2026-07-14