Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC
brief summary
The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.
detailed description
This is a global Phase 2, multicenter, single-arm, open label study of taletrectinib in patients of NSCLC harboring with ROS1 fusion gene.
About 214 patients will be enrolled and divided into 5 cohorts, depending on past history of ROS1 TKI treatment.
Taletrectinib is administered once daily in 21-day cycles. Patients will continue with the treatment on taletrectinib until progression of disease as determined by the investigator.
The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow-up will also be conducted.
official title
A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors