Grail tests first patient for TROPION-Lung12 Phase 3 study

GRAIL (GRAL) announced that the first patient has been tested for eligibility with the investigational GRAIL Non-Small Cell Lung Cancer, or NSCLC, ctDNA Assay in the global TROPION-Lung12 Phase 3 study evaluating adjuvant treatment regimens in patients with Stage I adenocarcinoma NSCLC. The study is sponsored by AstraZeneca (AZN) in collaboration with Daiichi Sankyo. The study, which is being conducted under an FDA-approved Investigational Device Exemption application, held by GRAIL, leverages GRAIL’s targeted methylation platform to detect ctDNA. With GRAIL’s blood-only approach, tissue analysis and bespoke panel development are not required, enabling simple integration into pharmaceutical clinical trial workflows. In TROPION-Lung12, patients will be screened with the GRAIL assay prior to surgery to inform eligibility for post-surgery randomization to an adjuvant treatment regimen (NCT06564844). Assay performance was previously reported in the Journal of Thoracic Oncology and presented at the 2023 North America Conference on Lung Cancer.