TEST:

Lunar-2

P=N/A; Recruiting --> Active, not recruiting | N=9000 --> 12000

This study will demonstrate sensitivity and specificity of the LUNAR-2 assay to detect lung cancer relative to standard of care screening modalities in high-risk populations. We will also evaluate whether factors such as comorbidities, pack year history, or medications affect assay accuracy. The impact of this research can inform blood-based early detection of lung cancer.

Cohort A is on track to meet enrollment targets by the end of 2023 and on track for final primary outcome data collection by December 2024. Clinical trial information: NCT05117840.

"Guardant Health, Inc...announced...positive results from ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode), an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer (CRC) in average-risk adults...In this study, two configurations of a multimodal blood-based screening test were evaluated independently - a cell-free DNA (cfDNA)-only test and a cfDNA test with protein biomarkers. The announced results were derived from the cfDNA-only test, which outperformed the cfDNA test with protein biomarkers."

Cohort A enrollment, targeting 9,000 subjects over 24 months at up to 120 global sites, began in January 2022. As of June 2022, 27 study sites have been activated and are enrolling.

Additional cancer-risk cohorts will begin enrolling as the study expands and are designated cohort B, C, etc. Cohort A: Eligibility criteria are aligned with lung cancer screening guidelines – age 50-80 years with > 20 pack-year smoking history who are current smokers or have quit < 15 years prior, without a cancer history, preinvasive lung lesions, or current treatment for pneumonia. Cohort A enrollment, targeting 9,000 subjects over 24 months at up to 120 global sites, began in January 2022.

P=N/A; Initiation date: Jan 2021 --> Jan 2022

P=N/A; Not yet recruiting --> Recruiting | Initiation date: Dec 2021 --> Jan 2021

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"Guardant Health, Inc...announced...that it has reached its target enrollment of 12,750 patients in ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Encounter), a registrational study to evaluate the performance of its LUNAR™-2 blood test to detect colorectal cancer (CRC) in average-risk adults. Subject to positive study results, the number of patients currently enrolled in ECLIPSE is targeted to support a premarket approval (PMA) submission to the U.S. Food and Drug Administration in 2022."

P=N/A; N=9000; Not yet recruiting; Sponsor:Guardant Health, Inc.

In this large early-stage CRC cohort, multimodal ctDNA assessment has high sensitivity for CRC detection with high specificity . Equivalent sensitivity in the asymptomatic cohort suggests this test will have clinically meaningful performance in an average risk screening population . A prospective registrational study is ongoing to evaluate the test in an average risk CRC screening cohort.

"Study features including mobile phlebotomy and remote site monitoring were implemented. This contributed to successful study execution during COVID-19, as demonstrated by the enrollment rebound observed as early as June 2020 which saw higher enrollment than prior months, even pre-COVID."

P; N=10000; Recruiting; Sponsor: Guardant Health, Inc.