Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
Expanded Access Treatment of Zidesamtinib (NVL-520) in Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
1 other identifier
expanded_access
N/A
10 countries
35
Brief Summary
The Expanded Access Program will provide an alternate mechanism for these patients, who lack satisfactory therapeutic alternatives and cannot participate in a zidesamtinib clinical trial, to access investigational zidesamtinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2025
CompletedFirst Posted
Study publicly available on registry
January 28, 2025
CompletedFebruary 17, 2026
January 1, 2026
January 22, 2025
February 12, 2026
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumor with documented ROS1 rearrangement.
- Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
- Enrollment in a clinical trial of zidesamtinib is not possible.
- Adequate organ function and bone marrow reserve.
You may not qualify if:
- Prior receipt of zidesamtinib.
- Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.
- Ongoing anti-cancer therapy.
- Eligible for ongoing clinical trial with zidesamtinib
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nuvalent Inc.lead
Study Sites (35)
University of Colorado Anschutz School of Medicine
Aurora, Colorado, 80045, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
Manhattan, New York, 10065, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Washington / Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, 69008, France
GCS IUCT Oncopole
Toulouse, Occitanie, 31059, France
CHU de Nantes
Nantes, Pays de la Loire Region, 44800, France
Institut Gustave Roussy
Villejuif, Île-de-France Region, 94800, France
IRCCS Istituto Tumori Giovanni Paolo II
Bari, 70124, Italy
L'Istituto Europeo di Oncologia S.r.l.
Milan, 20141, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
IRCCS Istituto Oncologico Veneto
Padua, 35128, Italy
AUSL della Romagna - Ravenna
Ravenna, 48121, Italy
Istituto Nazionale Tumori "Regina Elena
Roma, 00144, Italy
Antoni van Leeuwenhoek Hospital
Amsterdam, 1006 BE, Netherlands
Netherlands Cancer Institute: NKI
Amsterdam, 1066 CX, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
National University Hospital Singapore
Singapore, 119074, Singapore
National Cancer Centre Singapore
Singapore, 168583, Singapore
Uomi Cancer Center-Clinica Tres Torres
Barcelona, 08017, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Gregorio Marañón General University Hospital
Madrid, 28007, Spain
Hospital Univ Doce de Octubre
Madrid, 28041, Spain
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 100229, Taiwan
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
The Royal Marsden Hospital
London, SM2 5PT, United Kingdom
The Christie Hospital
Manchester, M20 4BX, United Kingdom