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A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Sponsor: Nuvalent Inc.
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
359
Start Date
2022-01-04
Completion Date
2028-12-31
Last Updated
2025-10-24
Healthy Volunteers
No
Interventions
Zidesamtinib (NVL-520)
Oral tablet of zidesamtinib (NVL-520)
Locations (63)
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