Astellas doses first patient in Phase 3 study of setidegrasib for advanced NSCLC
Astellas Pharma has dosed the first patient in a Phase 3 trial evaluating setidegrasib versus docetaxel in advanced NSCLC.
Wall Street Correspondent
TOKYO — Astellas Pharma Inc. dosed the first patient in a Phase 3 clinical trial evaluating its investigational protein degrader setidegrasib, according to a corporate release issued on September 23, 2026. The milestone advances the targeted asset into a trial against docetaxel for patients with previously treated, advanced non-small cell lung cancer carrying KRAS G12D mutations. Full details of the clinical milestone were detailed in a statement published via PR Newswire.
Strategic Context
The initiation of the randomized Phase 3 study represents the second late-stage trial launched for setidegrasib within a six-month window. Setidegrasib is positioned as a novel, investigational KRAS G12D-targeted protein degrader designed to address specific oncogenic drivers in advanced lung malignancies.
Forward Outlook
Clinical trial operators and oncology stakeholders are tracking the execution and enrollment timelines of this second Phase 3 study. The dual late-stage development strategy scales setidegrasib within Astellas' oncology pipeline as clinical development continues.
Sophia Brennan
Wall Street Correspondent
Covers IPOs, buybacks, and the capital-markets calendar out of New York.
