The Addario Lung Cancer Medical Institute (ALCMI) and Biocept announce a clinical collaboration and initiation of ALCMI-009 liquid biopsy clinical trial, which was developed and will be conducted by ALCMI and its consortium of U.S. and international oncology centers. In this study, which plans to enroll 400 patients, Biocept's Target Selector assay platform will be used to detect and assess cancer biomarkers found in both circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) from the blood of patients with lung cancer.
Lung cancer is the leading cause of cancer-related deaths worldwide. New therapies are available and others are in development to provide improved treatment options by targeting specific lung cancer biomarkers. Identifying these biomarkers using tissue biopsy can be challenging for many reasons, including the difficulty in performing a biopsy due to tumor location, limited tumor material due to small biopsy sizes, tumor heterogeneity both within the tumor material and between multiple metastatic sites, and risk of complications. All of these reasons, in addition to the relatively high cost of tumor biopsy, have increased the interest in obtaining molecular information from a simple blood sample.
"We are pleased to join forces with major research institutions and cutting-edge molecular diagnostics companies such as Biocept to conduct a large-scale trial evaluating the use of liquid biopsy to detect and monitor key lung cancer biomarkers," Steven Young, ALCMI's president & COO said.
The large prospective clinical trial, entitled "ALCMI-009: Evaluation of Liquid Biopsies in Localized and Advanced Lung Cancer Patients," will enroll 400 patients with advanced non-small cell lung cancer (NSCLC). Patients will have 4-6 blood samples drawn over the 12-month study duration period, for a cumulative total of 1,600 to 2,400 liquid biopsy data points. Blood samples will be shipped directly to Biocept's CLIA-certified, CAP-accredited laboratory for detection of key biomarkers including EGFR, BRAF, KRAS, ALK fusions, ROS1 fusions and PD-L1 expression. Facilitated by ALCMI and its global consortium of 25-member cancer institutions, the study's primary objective is to further validate the concordance of liquid biopsy to solid tissue biopsies at de novo presentation across the multicenter ALCMI research organization. This concordance will validate the use of a liquid biopsy sample when biopsy tissue is exhausted or difficult to obtain for biomarker stratification. The clinical trial will also seek to validate the utility of monitoring key biomarkers in lung cancer patients with a liquid biopsy, enumerating CTC counts, and quantifying ctDNA mutations, with the intent to illustrate drug response, predict treatment failure prior to progression observed using radiographic imaging, and identify resistance mechanisms (e.g. EGFR T790M).
Due to different goals for the different histologies and stages of lung cancer, the trial plans to distinguish between advanced NSCLC patients with squamous cell and non-squamous cell carcinoma, and plans to evaluate the clinical utility of liquid biopsy in additional patients with early-stage NSCLC (stages I-III) as well as small cell lung cancer (SCLC). Collected data from this study will be centralized in a first-of-its-kind, large-scale database that will include uniform and complete patient demographic, pathology and clinical information. Principal investigators for the study are Erin M. Bertino, MD, Division of Medical Oncology, Department of Internal Medicine of Wexner Medical Center at The Ohio State University, and Luis E. Raez, MD, Memorial Cancer Institute/Memorial Health Care System, Florida International University (FIU).