Flatiron Health, Foundation Medicine, and Genentech, a member of the Roche Group, in partnership with community and academic oncology practices, have launched a novel, low-interventional study to assess and improve clinical trials for patients living with advanced lung cancer.
The Prospective Clinico-Genomic study (NCT04180176) will pilot the use of a technology-enabled prospective data collection platform to facilitate, streamline and simplify the execution of clinical trials for advanced lung cancer.
The PCG Study, funded and sponsored by Genentech, is a feasibility study with secondary aims to better understand how genomic changes in a patient’s tumor may predict response or impact resistance to treatment in people diagnosed with metastatic non-small cell lung cancer or extensive stage small cell lung cancer by building a linked data- and bio-repository.
Flatiron’s prospective real-world data collection technology will be leveraged for this study, which will enroll approximately 1,000 patients. These patients will undergo serial liquid biopsies using Foundation Medicine’s liquid biopsy assay to assess genomic changes in their cancer over the course of treatment.
The clinical, genomic, imaging and outcomes data will be a part of a comprehensive data platform that is designed to accelerate research.
“Through technology-driven innovation, we have realized our vision of building a platform that enables meaningful clinical research while also minimizing the burden on clinicians and research teams,” Bobby Green, chief medical officer at Flatiron Health, said in a statement. “This includes features such as centralized and remote study monitoring, streamlined patient identification, and technology-assisted abstraction to eliminate duplicate data entry and the need to use a separate electronic data capture system.”
Since launching the study in December 2019, 14 practices from Flatiron’s network were activated: Alabama Oncology, Cancer & Hematology Centers of Western Michigan, Clearview Cancer Institute, Fort Wayne Medical Oncology and Hematology, Hematology Oncology Associates of Central New York, Hematology Oncology Associates of Fredericksburg, Highlands Oncology Group, Jackson Oncology Associates in Mississippi, New York Cancer & Blood Specialists, Oklahoma Cancer Specialists and Research Institute, RCCA-Central Jersey, Southeast Nebraska Cancer Center, Virginia Cancer Institute, and West Cancer Center. Additional research sites are planned over time.
“Clinical trials are critically important to advancing cancer research, but the way trials are run has in many ways not changed in decades, and continues to be burdensome and time-consuming,” Lee Schwartzberg, chief medical officer at OneOncology, and physician at West Cancer Center. “The PCG Study has the potential to help transform how clinical trials are conducted, ultimately making research more feasible for all sites and increasing the number of trial opportunities for patients. We hope that the study design and technology deployed in PCG will ultimately become standard practice and used across a wide swath of trials.”
At this year’s ASCO virtual scientific program, Genentech, Flatiron, Foundation Medicine and co-authors will present the study design and objectives in a Trials-In-Progress abstract titled, “A multi-stakeholder platform to prospectively link longitudinal real-world clinico-genomic, imaging, and outcomes data for patients with metastatic lung cancer.”