Phase 1/2, dose escalation and expansion study designed to evaluate the safety and
tolerability of 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
NVL-520 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 NVL-520 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 NVL-520 in patients with
advanced ROS1-positive NSCLC and other solid tumors.