A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Status:
Recruiting
Trial end date:
2026-10-31
Target enrollment:
Participant gender:
Summary
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/or 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.