Lung cancer study designed to understand genomic changes in patient tumors

May 19, 2020

Flatiron Health, Foundation Medicine, and Genentech—a member of the Roche Group—in partnership with community and academic oncology practices, have launched the Prospective Clinico-Genomic (PCG) Study, NCT04180176. PCG is a novel, low-interventional study that will pilot the use of a technology-enabled prospective data collection platform to facilitate, streamline and simplify the execution of clinical trials for patients living with 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 (NSCLC) 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. Leveraging technology developed following years of collaboration between Flatiron and Foundation Medicine, the clinical, genomic, imaging and outcomes data will be a part of a comprehensive data platform that is designed to accelerate research, a central part of Roche’s vision for personalized healthcare.

“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,” said Dr. 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.”

“Using new platforms to accelerate the development and delivery of the best possible medicines for every type of patient is central to our vision for personalized healthcare,” said Mark Lee, global head of personalized healthcare, product development, at Genentech. “The PCG Study represents an important step toward the next iteration of the clinical research ecosystem, opening up opportunities to extend clinical trials into the real world setting to more investigators and more patients than ever before.”

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.”

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