FIGHT-302: First-line pemigatinib vs gemcitabine + cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements

Fibroblast growth factor receptor (FGFR) 2 rearrangements resulting in dysregulated signaling are drivers of cholangiocarcinoma tumorigenesis, and occur almost exclusively in intrahepatic cholangiocarcinoma. Pemigatinib, a selective, potent, oral inhibitor of FGFR 1–3, has demonstrated efficacy and safety in a phase 2 study of patients with previously treated locally advanced/metastatic cholangiocarcinoma harboring FGFR2 fusions/rearrangements. We describe the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global, phase 3 study comparing the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced cholangiocarcinoma with FGFR2 rearrangements (NCT03656536). The primary endpoint is progression-free survival; secondary endpoints are objective response rate, overall survival, duration of response, disease control rate, safety, and quality of life.