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Trifluridine/tipiracil plus bevacizumab for third-line management of metastatic colorectal cancer: SUNLIGHT study design.

Josep TaberneroJulien TaiebGerald W PragerFortunato CiardielloMarwan FakihCatherine LegerRonan FougerayNadia AmellalEric van Cutsem
Published in: Future oncology (London, England) (2021)
Trifluridine/tipiracil (FTD/TPI) is an orally active formulation of trifluridine, a thymidine-based nucleoside analog, and tipiracil hydrochloride, a thymidine phosphorylase inhibitor that increases the bioavailability of trifluridine. Preliminary studies of FTD/TPI plus bevacizumab have produced encouraging results in the treatment of refractory metastatic colorectal cancer. Here, we describe the design of the multinational Phase III SUNLIGHT, an open-label study of FTD/TPI plus bevacizumab as third-line treatment for patients with unresectable metastatic colorectal cancer. A total of 490 patients will be randomized 1:1 to receive either FTD/TPI plus bevacizumab, or FTD/TPI monotherapy. The primary objective is to significantly improve overall survival with FTD/TPI plus bevacizumab compared with FTD/TPI monotherapy. The first patient was enrolled in November 2020.
Keyphrases
  • metastatic colorectal cancer
  • phase iii
  • open label
  • combination therapy
  • clinical trial
  • end stage renal disease
  • double blind
  • phase ii
  • chronic kidney disease
  • ejection fraction
  • smoking cessation
  • patient reported