EQUAL: EGFR ctDNA Quantitative Assessment for Lung Cancer Screening in Asian and Latinx Populations

What this Trial Is About

Researchers are studying a new blood test to screen for Epidermal Growth Factor Receptor (EGFR) positive lung cancer in healthy individuals at risk for the disease, particularly among East Asian and Latinx populations who cannot undergo regular lung cancer screening. The test focuses on detecting specific EGFR gene changes that make up most EGFR mutations in lung cancer. This study aims to evaluate whether the blood test can detect lung cancer early, even before symptoms appear. All participants will provide blood samples for the investigational circulating tumor DNA (ctDNA) assay, which tests for EGFR L858R and exon 19 deletions. If the test is positive or unclear, further verification will occur using a CLIA-certified test, followed by a lung CT scan if needed. Positive CT scans lead to referrals for more evaluation, while negative CT scans are repeated after 12 months. Participants may also join optional surveys, focus groups, or blood banking studies. During the study, participants will attend clinic visits for blood collection and complete questionnaires. Researchers will monitor lung cancer detection rates over two years, along with testing turnaround times, recruitment acceptability, and barriers to sample collection. Results will be shared with participants, and follow-up scans and evaluations will be provided as appropriate. The study plans to enroll about 1000 participants for blood sampling, with smaller groups for surveys and focus groups.

EQUAL: EGFR ctDNA QUantative Assessment for Lung Cancer Screening in Asian and Latinx Populations