TRUST-II: a global phase II study of taletrectinib in <i>ROS1</i> -positive non-small-cell lung cancer and other solid tumors
Misako Nagasaka, Yuichiro Ohe, Caicun Zhou, Chang‐Min Choi, Nong Yang, Geoffrey Liu, Enriqueta Felip, M. Pérol, Benjamin Besse, Jorgé Nieva, Luis E. Raez, Nathan A. Pennell, Anastasios Dimou, Filippo de Marinis, Fortunato Ciardiello, Takashi Seto, Zheyi Hu, Max Yu-Chen Pan, Weiqing Wang, Shuanglian Li, Sai‐Hong Ignatius Ou
Abstract
Crizotinib and entrectinib have been approved to treat ROS1 fusion-positive (ROS1+) non-small-cell lung cancer. However, unmet needs remain, including treatment of patients with resistance mutations, efficacy in brain metastasis and avoidance of neurological side effects. Taletrectinib was designed to: improve efficacy; overcome resistance to first-generation ROS1 inhibitors; and address brain metastasis while conferring fewer neurological adverse events. All of these features are demonstrated and supported by the interim data from the regional phase II TRUST-I clinical study. Here we describe the rationale and design of TRUST-II, a global phase II study of taletrectinib in patients with locally advanced/metastatic ROS1+ non-small-cell lung cancer and other ROS1+ solid tumors. The primary end point is confirmed objective response rate. Secondary end points include duration of response, progression-free survival, overall survival and safety. This trial is enrolling patients in North America, Europe and Asia.