CASCADE-LUNG Enrolls First Patients to Validate a Novel Lung Cancer Screening Test

Julie Barta, MD,

The first participants have been enrolled in the CASCADE-LUNG study (NCT05306288) by Delfi Diagnostics, according to a press release from BioSpace.¹

CASCADE-LUNG is a prospective,2 multi-center trial that will enroll up to 15,000 patients with lung cancer at the time of their low dose CT (LDCT) lung cancer screening and will verify the effectiveness of Delfi's liquid biopsy test for lung cancer detection of blood-based signaling.

"We know LDCT can save the lives of underserved and hard to reach populations who are traditionally left behind from important medical advances," said Julie Barta, MD, the co-principal investigator of the CASCADE-LUNG study, assistant professor of medicine at Thomas Jefferson University Hospitals, co-lead for the Lung Cancer, Screening and Nodules Program, a part of the Jane and Leonard Korman Respiratory Institute at Jefferson Health, and a member of the Sidney Kimmel Cancer Center, in the press release. "The prospect that a procedure as routine as a blood draw could be used to improve equitable screening while reducing the number of false positives, is very exciting and could contribute to reducing lung cancer mortality in this population."

Investigators in the trial will draw 30 ml blood specimens from patients at enrollment for up to 30 days of enrollment. Patients will also have their medical records reviewed at baseline and at 2 additional time points throughout the study.

End points include sensitivity, specificity, positive predictive value, and negative predictive value of the Delfi lung cancer screening test. The study will also observe the safety of patients associated with the blood sample given.²

Eligible patients are men and women aged 50 years or older who are current or former smokers and who have completed 20 more pack-years. Pack-year status is defined as the number of packs smoked per day multiplied by the number of years smoked.

Patients will be excluded if they have evidence of any cancer (including prior lung cancer) other than non-melanoma skin cancer or carcinoma in situ within 2 years prior to enrollment; if they have had prior systemic therapy, definitive therapy, radiation, or surgical resection for any cancer diagnosis within 2 years prior to enrollment, other than surgery for nonmelanoma skin cancer and biopsies; history of hematologic malignancies or myelodysplasia, organ tissue transplantation, or blood product transfusion within 120 days prior to enrollment; of if they are currently pregnant.

CASCADE-LUNG will include many hospitals within the Veterans Administration, making it a unique trial that which will focus on patient populations who disproportionally suffer from lung cancer. Delfi has made an effort to observe these types of patient populations.

"We are excited to initiate this important study and honored to be working with investigators all over the country, including leading researchers at hospitals embedded in their communities such as Jefferson, and the many hospitals that serve our nation's Veterans. There are roughly 900,000 Veterans eligible for lung cancer screening and very few today are getting screened. We are eager to try and address this shortfall," said Tara Maddala, PhD, Delfi's vice president of clinical development, in the press release. "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."

_References

_{1. Delfi diagnostics initiates 15,000-patient prospective lung cancer screening trial. Press release. BioSpace; May 9, 2022. Accessed May 10, 2022. https://bit.ly/3N0jjoQ}

_{2. CASCADE-LUNG: cancer screening assay using DELFI; a clinical validation study in lung (DELFI-L201). ClinicalTrials.gov. Updated April 1, 2022. Accessed May 10, 2022. https://clinicaltrials.gov/ct2/show/NCT05306288?term=CASCADE-LUNG&draw=2&rank=1}