NCT04737187

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

An Open-label, Randomized, Phase III Study Comparing Trifluridine/Tipiracil in Combination With Bevacizumab to Trifluridine/Tipiracil Monotherapy in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 492 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

Detailed description

This is an international, open-label, controlled two-arm, randomised phase III study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC. The analysis will be done after 331 events are reported. In order to observe this number of events, 490 patients will be randomised (1:1) to receive trifluridine/tipiracil in combination with bevacizumab (experimental arm) or trifluridine/tipiracil monotherapy (control arm).

Conditions

• Refractory Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Trifluridine/Tipiracil	Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest
DRUG	Bevacizumab	administered every 2 weeks (Day 1 and Day 15)

Timeline

• Start date: 2020-11-25
• Primary completion: 2022-07-19
• Completion: 2023-09-12
• First posted: 2021-02-03
• Last updated: 2024-09-24
• Results posted: 2023-12-26

Locations

99 sites across 14 countries: United States, Austria, Belgium, Brazil, Denmark, France, Germany, Hungary, Italy, Poland, Puerto Rico, Russia, Spain, Ukraine

Regulatory

• FDA-regulated drug study