OncoMatch/Clinical Trials/NCT05118789
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Is NCT05118789 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Zidesamtinib (NVL-520) for locally advanced solid tumor.
Treatment: Zidesamtinib (NVL-520) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: ROS1 rearrangement
Prior therapy
Cannot have received: ongoing anticancer therapy
Ongoing anticancer therapy
Lab requirements
Blood counts
bone marrow reserve
Kidney function
Liver function
Adequate baseline organ function and bone marrow reserve.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCI Medical Center · Orange, California
- Stanford Medicine · Palo Alto, California
- UC Davis Comprehensive Cancer Center · Sacramento, California
- University of Colorado Cancer Center · Denver, Colorado
- Georgetown University Medical Center · Washington D.C., District of Columbia
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