AACR 2023 | CASCADE-LUNG: validation of a blood-based assay that evaluates cfDNA patterns to detect lung cancer
Julie Barta, MD, Thomas Jefferson University, Philadelphia, PA, discusses the CASCADE-LUNG (NCT05306288) study, a prospective, observational, blood specimen collection study in the elevated-risk lung cancer screening population. Patients were enrolled at the time of their low dose CT (LDCT) lung cancer screening with a primary objective of determining the sensitivity and specificity of the Delfi Lung Cancer Screening Test (DLCST). DELFI (DNA evaluation of fragments for early interception) is a technology that uses low-coverage, whole-genome sequencing and machine learning to detect cancer signals in the blood. The primary endpoint is performance characteristics, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the DLCST. The study will also observe the safety of patients associated with the blood sample given. Eligible patients were men and women aged 50 years or older who are current or former smokers and who have completed 20 more pack-years. Patients were excluded if they had any evidence of cancer other than non-melanoma skin cancer or carcinoma in situ within 2 years prior to enrolment. This interview took place at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, FL.
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Transcript (edited for clarity)
The CASCADE-LUNG trial is a prospective observational trial to clinically validate a DNA fragmentomics approach to early detection of lung cancer among high-risk individuals. It builds on the lung cancer screening paradigm and so low-dose CT scan for lung cancer screening is one of the most impactful advances in the field of lung cancer over the past couple of decades. But we’re not doing enough to get patients in the door for screening, so uptake of low dose CT scan is very low, 10 to 15% of eligible individuals across the country have received low dose CT scans...
The CASCADE-LUNG trial is a prospective observational trial to clinically validate a DNA fragmentomics approach to early detection of lung cancer among high-risk individuals. It builds on the lung cancer screening paradigm and so low-dose CT scan for lung cancer screening is one of the most impactful advances in the field of lung cancer over the past couple of decades. But we’re not doing enough to get patients in the door for screening, so uptake of low dose CT scan is very low, 10 to 15% of eligible individuals across the country have received low dose CT scans. So, we need to do better with getting our high-risk patients screened. And in addition, only about 50% of patients with lung cancer would have been eligible for lung screening. So, with a blood test like we’re testing in the CASCADE-LUNG study, this potentially can increase access, increase acceptability of lung cancer screening, and thereby could potentially improve uptake as well as annual adherence with continued low-dose CT scans. In addition, if the blood test is informative about lung cancer risk, then that can shape some of our shared decision-making discussions with patients as well as help direct some nodule management strategies down the road. In terms of results, so we have over 60 sites activated on this clinical trial, we hope to have close to 90 sites with 15,000 participants. And our primary outcome is performance of the test for pathologic diagnosis of lung cancer at four months. Our sites are a mixture of academic institutions, community practices and VA sites as well because we really want to put an emphasis on diversity of the study population so that ultimately the results are generalizable. And of course, it’s a trial in progress, so we don’t have any results to share yet, but we’re well on our way to our accrual goal so hopefully we’ll have some findings soon.
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