The Expanded Access Program will provide an alternate mechanism for patients, who lacksatisfactory therapeutic alternatives and cannot participate in a neladalkib clinicaltrial, to access investigational neladalkib.
The purpose of this Expanded Access Program is to provide investigational ALK inhibitor,
neladalkib (NVL-655), for eligible patients with ALK-positive locally advanced or
metastatic NSCLC (ALK+ NSCLC) who have previously received lorlatinib or a
second-generation ALK tyrosine kinase inhibitor (TKI) and lack satisfactory therapeutic
alternatives and are unable to access neladalkib through a clinical trial.
Drug: NVL-655
Drug: NVL-655
Other Name: Neladalkib
Inclusion Criteria:
1. Age ≥18 years.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC with
a documented ALK rearrangement or activating ALK mutation.
3. Previously received lorlatinib or received at least one second-generation ALK TKI
and is either not eligible for or does not have access to lorlatinib, with no
comparable or satisfactory alternative treatment options, in the opinion of the
treating physician.
4. Enrollment in a clinical trial of neladalkib is not possible.
5. Adequate organ function and bone marrow reserve.
Exclusion Criteria:
1. Prior receipt of neladalkib.
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.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer - Vancouver
Vancouver, British Columbia, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, France
CHU de Nantes
Nantes, Pays De La Loire, France
National Cancer Centre Singapore
Singapore, Singapore
Ospedale Italiano di Lugano
Lugano, Ticino, Switzerland
Kantonsspital Luzern
Lucerne, Switzerland
Contact for Program Information
877 768 4303
MedicineAccess@clinigengroup.com
Not Provided