2022 World Conference on Lung Cancer (ePosters)-EP08.02-118. TRUST-II: A Global Phase II Study for Taletrectinib inROS1fusion Positive Lung Cancer and Other Solid Tumors

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The TRUST-II study is a global Phase 2 clinical trial evaluating the efficacy and safety of taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor, in patients with ROS1 fusion-positive lung cancer and other solid tumors. ROS1 oncogenic fusions are found in various cancers, including non-small cell lung cancer (NSCLC), and can lead to central nervous system (CNS) metastasis. Resistance to first-generation ROS1 inhibitors is common, and secondary mutations, such as the ROS1 G2032R mutation, contribute to resistance.<br /><br />The objective of this study is to overcome resistance to first-generation ROS1 inhibitors, address CNS metastasis, improve efficacy and safety, and reduce TRKB-related adverse events. The trial is currently recruiting patients and is expected to be completed in September 2024.<br /><br />The study will enroll patients from various regions, including North America, Europe, and Asia, with a total of 80 study sites in nine countries.<br /><br />Taletrectinib will be administered orally once daily at a dose of 600 mg until disease progression or unacceptable toxicity. The study includes four cohorts: one for chemotherapy-naïve patients with ROS1-positive NSCLC, one for patients who have received one prior ROS1 tyrosine kinase inhibitor (TKI), one for patients who have received two prior ROS1 TKIs, and one for patients with ROS1-positive solid tumors other than NSCLC.<br /><br />The primary objective of the study is to evaluate the efficacy of taletrectinib based on objective response rate (ORR) in patients with advanced or metastatic ROS1-positive NSCLC. Secondary objectives include evaluating the duration of response, progression-free survival, overall survival, and assessing the safety, tolerability, and pharmacokinetic profile of taletrectinib.<br /><br />Key inclusion criteria for enrollment in the study include confirmed diagnosis of locally advanced or metastatic NSCLC or other solid tumors, evidence of ROS1 fusion, measurable disease, performance status of 0 or 1, and adequate organ function.<br /><br />Overall, the TRUST-II study aims to evaluate the efficacy and safety of taletrectinib in patients with ROS1 fusion-positive cancers, with a focus on NSCLC, and to provide potential treatment options for patients who have developed resistance to first-generation ROS1 inhibitors.

Asset Subtitle

Misako Nagasaka

Meta Tag

Speaker Misako Nagasaka

Topic Metastatic Non-small Cell Lung Cancer - Molecular Targeted Treatments

Keywords

TRUST-II study

Phase 2 clinical trial

taletrectinib

ROS1 tyrosine kinase inhibitor

ROS1 fusion-positive lung cancer

solid tumors

oncogenic fusions

CNS metastasis

resistance to ROS1 inhibitors

G2032R mutation