Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients
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.
Timeline
- Start
- 2020-11-25
- Primary completion
- 2022-07-19
- Completion
- 2023-09-12
Outcome
Met primary endpoint
registry analysis (superiority test); Trifluridine/Tipiracil + Bevacizumab vs Trifluridine/Tipiracil; p < 0.001; Hazard Ratio (HR) 0.61 (95% CI 0.49 to 0.77) NCT04737187 ↗
release “the pivotal Phase 3 SUNLIGHT trial achieved clinically meaningful improvement in overall survival compared to trifluridine/tipiracil alone” taihooncology.com ↗
release “demonstrating that the trial met its primary endpoint of overall survival (OS).” taihooncology.com ↗
Publications
- Results Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Cruz FM, Wyrwicz L, Stroyakovskiy D, Papai Z, Poureau PG, Liposits G, Cremolini C, Bondarenko I, Modest DP, Benhadji KA, Amellal N, Leger C, Vidot L, Tabernero J; SUNLIGHT Investigators. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. doi: 10.1056/NEJMoa2214963.
- Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Wyrwicz L, Stroyakovskiy D, Liposits G, Bondarenko I, Modest DP, Amellal N, Tabernero J; SUNLIGHT Investigators. Plain language summary of SUNLIGHT: trifluridine/tipiracil and bevacizumab for refractory metastatic colorectal cancer. Future Oncol. 2024;20(36):2823-2832. doi: 10.1080/14796694.2024.2366100. Epub 2024 Jul 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Trifluridine/Tipiracil | Unknown | 35 mg/m2 | Oral |