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 an ALK tyrosine kinase
inhibitor (TKI) or eligible patients with other ALK-positive solid tumors, 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 or
other solid tumors with a documented ALK rearrangement or activating ALK mutation.
3. Previously received at least one ALK TKI (for patients with NSCLC) or any prior
therapy (for patients with other solid tumors), 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.
University Of California Irvine Medical Center
Orange, California, United States
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
Henry Ford Cancer Institute
Detroit, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
University of Washington / Fred Hutchinson Cancer Center
Seattle, Washington, United States
Royal North Shore Hospital
St Leonards, New South Wales, Australia
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
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
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
L'Istituto Europeo di Oncologia S.r.l.
Milan, Italy
IRCCS Istituto Oncologico Veneto
Padova, Italy
IRCCS Istituto Nazionale Tumori Regina Elena
Rome, Italy
Stichting Het Nederlands Kanker Instituut
Amsterdam, North Holland, Netherlands
Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
National University Hospital Singapore
Singapore, Singapore
National Cancer Centre Singapore
Singapore, Singapore
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Gerencia de Gestión Integrada A Coruna
A Coruña, Spain
Uomi Cancer Center-Clinica Tres Torres
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Kantonsspital Luzern
Lucerne, Switzerland
Ospedale Italiano di Lugano
Viganello, Switzerland
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, UK, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Contact for Program Information
877 768 4303
MedicineAccess@clinigengroup.com
Not Provided