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TRUST-II: a global phase II study of taletrectinib in ROS1-positive non-small-cell lung cancer and other solid tumors

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.

 

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It seems like you have provided information about the rationale and design of the TRUST-II global phase II study of taletrectinib in patients with ROS1+ non-small-cell lung cancer and other ROS1+ solid tumors. The study aims to address unmet needs in the treatment of ROS1 fusion-positive cancers, including overcoming resistance to existing inhibitors, efficacy in brain metastasis, and reducing neurological side effects.

The primary endpoint of the TRUST-II study is the confirmed objective response rate, which measures the proportion of patients whose tumors show a predefined amount of shrinkage. Secondary endpoints include duration of response (how long the response to treatment lasts), progression-free survival (the length of time during and after treatment that the patient lives with the disease without it getting worse), overall survival (the length of time from the start of the treatment that patients are still alive), and safety assessments to monitor and manage adverse events related to the treatment.

The study is conducted globally, enrolling patients in North America, Europe, and Asia, which allows for a diverse and representative patient population. The goal of TRUST-II is to evaluate the efficacy and safety of taletrectinib in ROS1+ non-small-cell lung cancer and other ROS1+ solid tumors, addressing the limitations of existing treatments and potentially providing a better therapeutic option for patients with these conditions.

Related Products

Cat.No. Product Name Information
S8901 Taletrectinib (DS-6051b) Taletrectinib (DS-6051b, AB-106) is a new-generation selective ROS1/NTRK inhibitor with ic50 of 0.207 nM,0.622 nM,2.28 nM and 0.980 nM for ROS1,NTRK1,NTRK2 and NTRK3,respectively.

Related Targets

Trk receptor ROS1