SUNLIGHT is an open-label study, which means both the researcher and the participant will know the treatment they are receiving.
Participants in this study will be randomly assigned to get either Trifluridine/tipiracil or Trifluridine/tipiracil with Bevacizumab. Patients that start on trial receiving may have the opportunity to receive Trifluridine/tipiracil with Bevacizumab if their cancer is not responding to therapy.
Trifluridine/tipiracil is a pill taken by mouth. Bevacizumab is given intravenously, which means the medicine is delivered directly into your bloodstream through an IV or port.
In the SUNLIGHT trial, everyone on the study will take Trifluridine/tipiracil 5 days on/2 days off, over 2 weeks, followed by a 14-day rest. Participants who take part in the study who also get Bevacizumab will get it as an infusion administered every 2 weeks (Day 1 and Day 15). Cycles will continue until a person’s cancer worsens, a person experiences a side effect that requires treatment to stop, or they decide they no longer want to participate in the trial.
The most common side effects of Trifluradine/tipiracil are: