NEW YORK – Delfi Diagnostics said on Monday that it has begun enrollment for the second out of multiple planned clinical trials of its liquid biopsy test for the early detection of lung cancer.
The CASCADE-LUNG study will enroll approximately 15,000 participants at high risk for lung cancer to undergo liquid biopsy screening at the same time they receive low-dose CT lung cancer screening. The goal of the trial is to clinically validate Delfi's test for detection of undiagnosed lung cancer. High risk is defined as being over 50 with a history of heavy smoking.
Last year, Delfi launched a smaller trial, the DELFI-L101 study, in about 2,500 participants who are at high risk for lung cancer or who already have untreated lung cancer or another type of cancer, according to the latest clinical trial update. That study is designed to evaluate the accuracy of the test.
Unlike DELFI-L101, CASCADE-LUNG will exclude subjects with evidence of any cancer other than skin cancer, and its primary outcome measure will be performance characteristics of the test such as sensitivity and specificity. The trial will involve a number of Veterans Administration hospitals in order to reach populations disproportionately affected by lung cancer.
Delfi's platform, named DELFI for DNA Evaluation of Fragments for Early Interception, employs genome-wide analysis of cell-free DNA fragmentation to detect cancer. Delfi researchers published a study in August 2021 showing that analysis of cfDNA, combined with clinical risk factors, carcinoembryonic antigen (CEA) levels, and CT imaging, detected 94 percent of patients with cancer. The cfDNA fragmentation profiles were also able to accurately distinguish patients with small cell lung cancer from those with non-small cell lung cancer.
According to a report from the President's Cancer Panel, only 5 percent of eligible patients receive screening for lung cancer by low-dose CT imaging recommended by United States Preventive Services Taskforce guidelines. Delfi believes that hundreds of thousands of deaths worldwide could be prevented through improved early lung cancer detection.
"The results of these studies will help establish the clinical evidence to support the FDA's review of Delfi's lung cancer screening product, and also build the foundation needed for Delfi to move into new indications, such as screening for multiple cancers," said Tara Maddala, Delfi's VP of clinical development, in a statement.