Dr. Mehta on Rationale for a Phase II Trial of TAS-102/Ramucirumab in Gastric/GEJ Cancer

Rutika Mehta, MD, MPH, gastrointestinal medical oncologist, Moffitt Cancer Center, discusses the rationale and design of a phase II study of TAS-102 (trifluridine/tipiracil; Lonsurf) in combination with ramucirumab (Cyramza) in patients with advanced, refractory gastric or gastroesophageal junction (GEJ) adenocarcinoma (NCT03686488).

Neurotoxicity and overlapping toxicities are fairly common between first- and second-line treatments, says Mehta. The goal is to develop novel combinations that do not result in such toxicities. Therefore, there are many clinical trials that have been emerging in this space in which investigators are exploring novel combinations with ramucirumab. One such combination is exploring ramucirumab plus the oral agent TAS-102.

The phase II trial is currently enrolling and has an anticipated accrual of 25 patients. To date, 7 patients have been accrued to the trial. Eligible patients have progressed on a prior fluoropyrimidine and platinum-based doublet in the first-line setting, says Mehta. Notably, patients could have received prior immunotherapy but could not have received prior ramucirumab or TAS-102 therapy. Additional exclusion criteria include a high bleeding risk and evidence of arterial clot, concludes Mehta.