A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) (NCT05118789)
A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UCI Medical Center — Orange, California
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (63 Sites)
Showing the first 25 of 63 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
- University of Miami — Coral Gables, Florida
- University of Chicago — Chicago, Illinois
- Mass General Hospital — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Henry Ford Cancer Institute — Detroit, Michigan
- Washington University School of Medicine — St Louis, Missouri
- NYU Langone Health — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Atrium Health Levine Cancer Institute — Charlotte, North Carolina
- Ohio State University — Columbus, Ohio
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- Sarah Cannon Research Institute — Nashville, Tennessee
- MD Anderson Cancer Center — Houston, Texas
- NEXT Oncology - Virginia Cancer Specialists — Fairfax, Virginia
- University of Washington / Fred Hutchinson Cancer Center — Seattle, Washington
- Chris O'Brien Lifehouse — Camperdown, New South Wales
- Peter MacCallum Cancer Centre — Melbourne, Victoria
- University Hospital Leuven — Leuven,
- Cross Cancer Institute — Edmonton, Alberta
- Princess Margaret Cancer Research — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (857) 357-7000
Email: clinicaltrials@nuvalent.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.