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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Nuvalent Inc. • ClinicalTrials.gov ID: NCT05118789

Registry updated: 2026-09-24
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Description

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.

Interventions

  • Zidesamtinib (NVL-520) (Drug)
    Oral tablet of zidesamtinib (NVL-520)

Eligibility criteria

Inclusion Criteria: 1. Age ≥18 years (Cohort 2e only: Age ≥12 years). 2. Disease Criteria: 1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement. 2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement. 3. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement. 3. Prior anticancer treatment (except cohort 2a). 4. 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. 5. Adequate baseline organ function and bone marrow reserve. Exclusion Criteria: 1. Patient's cancer has a known oncogenic driver alteration other than ROS1. 2. Known allergy/hypersensitivity to excipients of NVL-520. 3. Major surgery within 4 weeks of first dose of study drug. 4. Ongoing anticancer therapy. 5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

Conditions

Locally Advanced Solid Tumor Metastatic Solid Tumor

Locations

  • UCI Medical Center — Orange, California, United States
  • Stanford Medicine — Palo Alto, California, United States
  • UC Davis Comprehensive Cancer Center — Sacramento, California, United States
  • University of Colorado Cancer Center — Denver, Colorado, United States
  • Georgetown University Medical Center — Washington D.C., District of Columbia, United States
  • University of Miami — Coral Gables, Florida, United States
  • University of Chicago — Chicago, Illinois, United States
  • Mass General Hospital — Boston, Massachusetts, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • Henry Ford Cancer Institute — Detroit, Michigan, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • NYU Langone Health — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Atrium Health Levine Cancer Institute — Charlotte, North Carolina, United States
  • Ohio State University — Columbus, Ohio, United States
  • Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
  • Sarah Cannon Research Institute — Nashville, Tennessee, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • NEXT Oncology - Virginia Cancer Specialists — Fairfax, Virginia, United States
  • University of Washington / Fred Hutchinson Cancer Center — Seattle, Washington, United States
  • Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
  • Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
  • University Hospital Leuven — Leuven, Belgium
  • Cross Cancer Institute — Edmonton, Alberta, Canada
  • Princess Margaret Cancer Research — Toronto, Ontario, Canada
  • Centre Legon Berard — Lyon, France
  • CHU de Nantes — Nantes, France
  • Claudius Regaud Institute — Toulouse, France
  • Institute Gustave Roussy — Villejuif, France
  • Cologne University Hospital — Cologne, Germany
  • Università Politecnica Marche — Ancona, Italy
  • IRCCS Istituto Tumori Giovanni Paolo II — Bari, Italy
  • Istituto Europeo di Oncologia — Milan, Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy
  • Istituto Oncologico Veneto — Padova, Italy
  • Ospedale Santa Maria delle Croci — Ravenna, Italy
  • Istituto Nazionale Tumori Regina Elena — Rome, Italy
  • Kanagawa Cancer Center — Kanagawa, Japan
  • Okayama University Hospital — Okayama, Japan
  • Kindai University Hospital — Osaka, Japan
  • Shizuoka Cancer Center — Shizuoka, Japan
  • National Cancer Center Hospital — Tokyo, Japan
  • The Cancer Institute Hospital Of JFCR — Tokyo, Japan
  • Wakayama Medical University Hospital — Wakayama, Japan
  • Netherlands Cancer Institute — Amsterdam, Netherlands
  • University Medical Centre Groningen — Groningen, Netherlands
  • National University Hospital Singapore — Singapore, Singapore
  • National Cancer Centre Singapore — Singapore, Singapore
  • National Cancer Center — Gyeonggi-do, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Yonsei University Health System — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • University Hospital of A Coruña — A Coruña, Spain
  • UOMI Cancer Center - Clinica Tres Torres — Barcelona, Spain
  • Vall d'Hebron University Hospital — Barcelona, Spain
  • Gregorio Marañón Hospital — Madrid, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Hospital Universitario HM Sanchinarro — Madrid, Spain
  • Chung Shan Medical University Hospital — Taichung, Taiwan
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Royal Marsden Hospital — London, United Kingdom
  • Christie NHS Foundation Trust — Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record