Phase 3 Study of Setidegrasib With mFOLFIRINOX or NALIRIFOX Chemotherapy for Adults With KRAS G12D Mutated Metastatic Pancreatic Cancer

What this Trial Is About

Pancreatic cancer is often diagnosed late, when it has spread to other parts of the body, making treatment challenging. This study focuses on adults with metastatic pancreatic cancer who have a specific KRAS G12D gene mutation. Researchers aim to evaluate whether adding setidegrasib to standard chemotherapy improves survival compared to chemotherapy with placebo. The study also explores how setidegrasib affects disease progression, symptoms, how the body processes the drug, and its safety. Participants receive either setidegrasib or placebo once weekly, combined with one of two chemotherapy regimens mFOLFIRINOX or NALIRIFOX. Chemotherapy is given in 28-day cycles through intravenous infusions. The choice of chemotherapy is determined by the doctor, with NALIRIFOX given only after confirming the safety of setidegrasib combined with it in another study. Treatment continues until cancer worsens, side effects become intolerable, other treatments are started, or the participant or doctor decides to stop. During the study, participants are regularly monitored with safety checks, health assessments, and laboratory tests. Researchers measure overall survival up to 3.5 years, along with progression-free survival, pain improvement, quality of life, response to treatment, and side effects. Pharmacokinetics of setidegrasib are studied up to 9 months. The study involves ongoing evaluation of participants wellbeing and medical status throughout the treatment period.

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer