Global clinical cancer genomics company Inivata has announced the initiation of its US clinical validation study (INI-001) of a new approach to circulating tumour DNA (ctDNA) in non-small-cell lung cancer (NSCLC).
The trial will be organised within more than 30 US-based sites.
It will be led by co-principal investigators, Ramaswamy Govindan, director of section of oncology of Washington University School of Medicine and Ed Kim, chairman of solid tumour oncology and investigational therapeutics of Levine Cancer Institute.
The study is expected to enrol several hundred patients.
INI-001 is a prospective study to assess the performance of Inivata's targeted molecular profiling liquid biopsy platform compared with tissue based molecular profiling in patients with advanced NSCLC.
Vector Oncology has been selected as the study's clinical research organisation.
Patient samples will be examined at Inivata's recently opened CLIA-accredited laboratory in Research Triangle Park, North Carolina.
Vector Oncology president and chief medical officer Lee Schwartzberg said: "Liquid biopsy approaches allow for far less invasive analysis of a patient's cancer and have the potential to greatly improve care.
"This is an important, rigorously designed trial and we look forward to working with Inivata and the study centres to advance the understanding of ctDNA analysis in a clinical setting."
Dr Govindan said: "Tissue biopsies are highly invasive, particularly in lung cancer, and can fail as a result of lack of tissue availability.
"The launch of this trial is an exciting step in establishing the clinical utility of liquid biopsies, in a disease which remains a significant cause of cancer-related mortality."
Dr Kim noted: "I am excited to see Inivata take this important step to begin to establish a robust clinical evidence base for their novel approach to ctDNA analysis.
"The potential of ctDNA to unlock real-time genomic information to help us treat lung cancer patients more effectively has transformative potential, and I am eager to work with the strong scientific and medical teams at Inivata to demonstrate the clinical utility of these approaches over time."
The INI-001 (NCT02906852) trial is expected to be completed in July 2017.
Inivata chief medical officer Clive Morris said: "We are thrilled to partner with outstanding national cancer centres across the US to launch our INI-001 study, which will correlate our highly sensitive ctDNA analysis from a simple blood draw with standard of care tissue biopsies.
"This data will be a key part of the evidence to support the use of Inivata's proprietary platform in helping physicians improve the clinical outcomes of their cancer patients."
The primary outcome measure is concordance in the detection of molecular abnormalities, making use of Inivata's liquid biopsy panel with detection using a standard of care tissue biopsy analysis.
Secondary outcome measures include sensitivity and specificity comparisons, and an analysis of the proportion of NSCLC patients eligible for targeted therapy compared to standard of care alone.