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

Future Oncol. 2021 Jun;17(16):1977-1985. doi: 10.2217/fon-2020-1238. Epub 2021 Feb 11.


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.

Keywords: FTD/TPI; Phase III; bevacizumab; metastatic colorectal cancer; randomized controlled trial; refractory; third line; trifluridine/tipiracil.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bevacizumab / administration & dosage
  • Clinical Trials, Phase III as Topic
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / metabolism
  • Colorectal Neoplasms / pathology
  • Drug Combinations
  • Female
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Neoplasm Metastasis
  • Pyrrolidines / administration & dosage
  • Randomized Controlled Trials as Topic
  • Thymine / administration & dosage
  • Trifluridine / administration & dosage
  • Young Adult


  • Drug Combinations
  • Pyrrolidines
  • trifluridine tipiracil drug combination
  • Bevacizumab
  • Thymine
  • Trifluridine

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