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
Massachusetts General Hospital
Boston, Massachusetts, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, France
Institut Gustave Roussy
Villejuif, Île-de-France, France
Netherlands Cancer Institute: NKI
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
National Cancer Centre Singapore
Singapore, Singapore
The Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Contact for Program Information
877 768 4303
MedicineAccess@clinigengroup.com
Not Provided