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) 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 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.
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
Institut Gustave Roussy
Villejuif, Île-de-France, France
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