NEW YORK – Roche subsidiary Foundation Medicine announced on Friday that it is partnering with the Lung Cancer Research Foundation and Lung Cancer Mutation Consortium to provide comprehensive genomic profiling tests (CGP) in a screening trial.
FMI will be the sole provider of CGP tests for the LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancer (LEADER) trial, which involves multiple academic study sites and pharmaceutical supporters. The trial will use FMI's tissue-based FoundationOne CDx assay and its blood-based FoundationOne Liquid CDx test, both of which are approved by the US Food and Drug Administration.
The trial will screen for 11 actionable driver mutations in 1,000 patients with high-risk, resectable non-small cell lung cancer (NSCLC) who are candidates for neoadjuvant therapy. Foundation's tests will be used to screen patients for those actionable driver mutations with the goal of helping researchers determine "how blood-based CGP testing can complement tissue-based CGP testing to inform targeted treatment in resectable NSCLC," the firm said in a statement.
Identifying patients with biomarker-positive tumors for enrollment to several matched therapeutic trials will allow the LEADER trial to "develop essential data that can be used to support oncologists in their personalized treatment planning for cancer patients prior to such patients undergoing surgery," it added.
"The neoadjuvant setting is a rapidly evolving space for the development of precision treatment options in lung cancer," FMI's Head of Clinical Development Geoff Oxnard said in a statement. "Enabling trials in this setting will continue to help us understand the impact of targeted therapies in the curative treatment of NSCLC."