NCT04919811

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Nuvation Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Taletrectinib	400mg or 600mg QD

Timeline

• Start date: 2021-09-01
• Primary completion: 2025-06-11
• Completion: 2027-12-01
• First posted: 2021-06-09
• Last updated: 2026-01-07

Locations

77 sites across 9 countries: United States, Canada, China, France, Italy, Japan, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study