FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements

FGFR2 rearrangements, which lead to dysregulated signaling, are key drivers of cholangiocarcinoma (CCA) tumorigenesis and are found almost exclusively in intrahepatic CCA. Pemigatinib, a selective and potent oral inhibitor of FGFR1-3, has shown both efficacy and safety in a Phase II study involving patients with previously treated, locally advanced or metastatic CCA with FGFR2 fusions/rearrangements. We outline the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global Phase III trial that compares the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced CCA harboring FGFR2 rearrangements (NCT03656536). The primary endpoint is progression-free survival, while secondary endpoints include objective response rate, overall survival, duration of response, disease control rate, safety, and quality of life. Clinical Trial Registration: NCT03656536 (ClinicalTrials.gov).