Astellas Doses First Patient in Phase 3 Lung Cancer Trial of Setidegrasib
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Tokyo – September 24, 2026 -- Astellas Pharma Inc. (TSE: 4503) has dosed the first patient in a Phase 3 study evaluating setidegrasib, an investigational KRAS G12D-targeted protein degrader, against docetaxel in previously treated non-small cell lung cancer (NSCLC) patients carrying the KRAS G12D mutation.
Trial targets patients who progressed on chemotherapy and checkpoint inhibitors
The randomized, open-label study will enroll approximately 356 patients across multiple countries whose locally advanced or metastatic NSCLC has progressed after platinum-based chemotherapy and checkpoint inhibitor therapy. Dual primary endpoints are progression-free survival, assessed by blinded independent central review, and overall survival.