The Expanded Access Program will provide an alternate mechanism for these patients, wholack satisfactory therapeutic alternatives and cannot participate in a zidesamtinibclinical trial, to access investigational zidesamtinib.
The purpose of this Expanded Access Program is to provide access to zidesamtinib
(NVL-520) an investigational therapy for eligible patients with ROS1 fusion-positive
advanced non- small cell lung cancer (ROS1+ NSCLC) who have previously received ≥ 1 prior
ROS1 tyrosine kinase inhibitor (TKI) or eligible patients with other ROS1-positive solid
tumors who have previously received any prior commercially-available or investigational
therapy, and lack satisfactory therapeutic alternatives and are unable to access
zidesamtinib through a clinical trial.
Drug: NVL-520
Oral tablet
Other Name: Zidesamtinib
Inclusion Criteria:
1. Age ≥18 years.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or
other solid tumor with documented ROS1 rearrangement.
3. Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory
alternative treatment options, in the opinion of the treating physician.
4. Enrollment in a clinical trial of zidesamtinib is not possible.
5. Adequate organ function and bone marrow reserve.
Exclusion Criteria:
1. Prior receipt of zidesamtinib.
2. Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or
participation in other studies within timeframe indicated in the protocol.
3. Ongoing anti-cancer therapy.
4. Eligible for ongoing clinical trial with zidesamtinib
University of Colorado Anschutz School of Medicine
Aurora, Colorado, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
Manhattan, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 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
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, France
GCS IUCT Oncopole
Toulouse, Occitanie, France
CHU de Nantes
Nantes, Pays de la Loire Region, France
Institut Gustave Roussy
Villejuif, Île-de-France Region, France
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
L'Istituto Europeo di Oncologia S.r.l.
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
IRCCS Istituto Oncologico Veneto
Padova, Italy
AUSL della Romagna - Ravenna
Ravenna, Italy
Istituto Nazionale Tumori "Regina Elena
Roma, Italy
Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Netherlands Cancer Institute: NKI
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
National University Hospital Singapore
Singapore, Singapore
National Cancer Centre Singapore
Singapore, Singapore
Uomi Cancer Center-Clinica Tres Torres
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Gregorio Marañón General University Hospital
Madrid, Spain
Hospital Univ Doce de Octubre
Madrid, Spain
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
The Royal Marsden Hospital
Sutton, Surrey, United Kingdom
The Royal Marsden Hospital
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Contact for Program Information
877 768 4303
MedicineAccess@clinigengroup.com
Not Provided