Astellas Pharma has initiated an international phase 3 study of setidegrasib, a KRAS G12D-targeted protein degrader, in non-small cell lung cancer. The study will evaluate patients with KRAS G12D-positive NSCLC that has progressed after treatment or is locally advanced or metastatic, comparing the treatment with docetaxel.
Astellas Pharma announced that it has initiated an international phase 3 study of its investigational drug setidegrasib in non-small cell lung cancer. The study will include patients with locally advanced or metastatic NSCLC who have KRAS G12D-mutated disease that has progressed during or after first-line treatment with platinum-based chemotherapy or an immune checkpoint inhibitor.
The phase 3 study will evaluate whether setidegrasib demonstrates antitumor activity by suppressing cancer-cell signaling through the degradation and removal of the KRAS G12D protein, with the treatment compared against docetaxel. Initial dosing has already begun, and the study is being conducted with completion targeted for 2026.