A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Recruiting now · Phase 1/Phase 2

Conditions studied: Locally Advanced Solid Tumor, Metastatic Solid Tumor

In brief

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.

Key facts

Study ID

NCT05118789

Run by

Nuvalent Inc.

People needed

359

Starts

2022-01-04

Expected to finish

2028-12-31

Last updated by the study team

2025-10-24

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years (Cohort 2e only: Age ≥12 years).
• Disease Criteria:
• Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.
• Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement.
• Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.
• Prior anticancer treatment (except cohort 2a).
• Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1. Phase 2: Must have measurable disease according to RECIST 1.1.
• Adequate baseline organ function and bone marrow reserve.

You may not qualify if…

• Patient's cancer has a known oncogenic driver alteration other than ROS1.
• Known allergy/hypersensitivity to excipients of NVL-520.
• Major surgery within 4 weeks of first dose of study drug.
• Ongoing anticancer therapy.
• Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

Where it is running

• UCI Medical Center — Orange, California, United States (enrolling)
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• Stanford Medicine — Palo Alto, California, United States (enrolling)
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• University of Miami — Coral Gables, Florida, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Mass General Hospital — Boston, Massachusetts, United States (enrolling)
• University of Colorado Cancer Center — Denver, Colorado, United States (enrolling)
• Henry Ford Cancer Institute — Detroit, Michigan, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Atrium Health Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• NEXT Oncology - Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• University of Washington / Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• University Hospital Leuven — Leuven, Belgium (enrolling)
• Cross Cancer Institute — Edmonton, Alberta, Canada (enrolling)
• Princess Margaret Cancer Research — Toronto, Ontario, Canada (enrolling)
• Centre Legon Berard — Lyon, France (enrolling)

Full record on ClinicalTrials.gov

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