Spots Global Cancer Trial Database for A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
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Trial Identification
Brief Title: A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Official Title: A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)
Study ID: NCT05118789
Interventions
Study Description
Brief Summary: Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of 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 NVL-520 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 NVL-520 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 NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors.
Detailed Description: In Phase 2, study patients will be enrolled into 5 distinct expansion cohorts: * Cohort 2a: ROS1-positive NSCLC naïve to Tyrosine Kinase Inhibitor (TKI) therapy and up to 1 prior chemotherapy and/or immunotherapy. * Cohort 2b: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy. * Cohort 2c: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy. * Cohort 2d: ROS1-positive NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior chemotherapy and/or immunotherapy. * Cohort 2e: ROS1-positive solid tumor and progressed on any prior therapy.
Keywords
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, District of Columbia, United States
University of Miami, Coral Gables, Florida, United States
Mass General Hospital, Boston, Massachusetts, United States
Henry Ford Cancer Institute, Detroit, Michigan, United States
Washington University School of Medicine, Saint 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
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
Hospital Center University De Toulouse, Toulouse, , France
Institute Gustave Roussy, Villejuif, , France
Cologne University Hospital, Cologne, , Germany
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Netherlands Cancer Institute, Amsterdam, , Netherlands
University Medical Centre Groningen, Groningen, , Netherlands
National University Hospital Singapore, Singapore, , Singapore
National Cancer Centre Singapore, Singapore, , Singapore
UOMI Cancer Center - Clinica Tres Torres, Barcelona, , Spain
Vall d'Hebron University Hospital, Barcelona, , Spain
University Hospital of A Coruña, Coruna, , 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
Contact Details
Name: Vivek Upadhyay, MD, MBI
Affiliation: Nuvalent Inc.
Role: STUDY_DIRECTOR
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