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FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements Bekaii-Saab, Tanios S Valle, Juan W Van Cutsem, Eric Furuse, Junji Ioka, Tatsuya Rimassa, Lorenza Macarulla Mercadé, Teresa Institut Català de la Salut [Bekaii-Saab TS] Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, AZ 85054, USA. [Valle JW] Division of Cancer Sciences, University of Manchester & Department of Medical Oncology, The Christie Hospital NHS Foundation Trust, The University of Manchester, Manchester, UK. [Van Cutsem E] Department of Oncology, University of Leuven, Leuven, Belgium. [Rimassa L] Department of Oncology and Hematology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy. [Furuse J] Department of Medical Oncology, Kyorin University, Tokyo, Japan. [Ioka T] Department of Cancer Survey and Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan. [Macarulla T] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Conductes biliars - Càncer - Tractament ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome::Progression-Free Survival DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Adenocarcinoma::Cholangiocarcinoma Other subheadings::Other subheadings::Other subheadings::/drug therapy TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento::supervivencia libre de progresión ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::adenocarcinoma::colangiocarcinoma Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia FGFR; Colangiocarcinoma; Pemigatinib FGFR; Colangiocarcinoma; Pemigatinib FGFR; Cholangiocarcinoma; Pemigatinib FGFR2 rearrangements resulting in dysregulated signaling are drivers of cholangiocarcinoma (CCA) tumorigenesis, and occur almost exclusively in intrahepatic CCA. Pemigatinib, a selective, potent, oral inhibitor of FGFR1–3, has demonstrated efficacy and safety in a Phase II study of patients with previously treated locally advanced/metastatic CCA harboring FGFR2 fusions/rearrangements. We describe the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global, Phase III study comparing the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced CCA with FGFR2 rearrangements (NCT03656536). The primary end point is progression-free survival; secondary end points are objective response rate, overall survival, duration of response, disease control rate, safety and quality of life. 2021-11-17T13:14:07Z 2021-11-17T13:14:07Z 2020-10 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Bekaii-Saab TS, Valle JW, Van Cutsem E, Rimassa L, Furuse J, Ioka T, et al. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. 2020 Oct;16(30):2385–99. 1744-8301 https://hdl.handle.net/11351/6560 10.2217/fon-2020-0429 32677452 000595834200002 eng Future Oncology;16(30) https://doi.org/10.2217/fon-2020-0429 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf application/pdf Future Medicine Scientia