Study #2022-0263
A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)
MD Anderson Study Status
Not Accepting
Treatment Agent
Zidesamtinib (NVL-520)
Description
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of zidesamtinib (NVL-520), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of zidesamtinib in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of zidesamtinib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Study phase:
Physician name:
George Blumenschein
Department:
Thoracic/Head & Neck Medical Oncology
For general questions about clinical trials:
1-877-632-6789
Help #EndCancer
Give Now
Donate Blood
Our patients depend on blood and platelet donations.
Shop MD Anderson
Show your support for our mission through branded merchandise.