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 Colorado Anschutz School of Medicine
Aurora 5412347, Colorado 5417618, United States
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926, United States
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, United States
Henry Ford Cancer Institute
Detroit 4990729, Michigan 5001836, United States
Washington University
St Louis 4407066, Missouri 4398678, United States
NYU Langone Health
New York 5128581, New York 5128638, United States
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638, United States
Duke University
Durham 4464368, North Carolina 4482348, United States
The Ohio State University
Columbus 4509177, Ohio 5165418, United States
Royal North Shore Hospital
St Leonards 8029783, New South Wales 2155400, Australia
Peter MacCallum Cancer Centre
Melbourne 2158177, Victoria 2145234, Australia
Cross Cancer Institute
Edmonton 5946768, Alberta 5883102, Canada
BC Cancer - Vancouver
Vancouver 6173331, British Columbia 5909050, Canada
Princess Margaret Hospital
Toronto 6167865, Ontario 6093943, Canada
Centre Leon Berard
Lyon 2996944, Auvergne-Rhône-Alpes 11071625, France
GCS IUCT Oncopole
Toulouse 2972315, Occitanie 11071623, France
CHU de Nantes
Nantes 2990969, Pays de la Loire Region 2988289, France
Institut Gustave Roussy
Villejuif 2968705, Île-de-France Region 3012874, France
Stichting Het Nederlands Kanker Instituut
Amsterdam 2759794, North Holland 2749879, Netherlands
National University Hospital Singapore
Singapore 1880252, Singapore
National Cancer Centre Singapore
Singapore 1880252, Singapore
Seoul National University Hospital
Seoul 1835848, Jongno-gu, South Korea
Kantonsspital Luzern
Lucerne 2659811, Switzerland
Ospedale Italiano di Lugano
Viganello 2658135, Switzerland
National Cheng Kung University Hospital
Tainan City 1668355, Taiwan
National Taiwan University Hospital
Taipei 1668341, Taiwan
The Royal Marsden Hospital
Sutton 2636503, Surrey, United Kingdom
The Royal Marsden Hospital
London 2643743, UK, United Kingdom
Contact for Program Information
877 768 4303
MedicineAccess@clinigengroup.com
Not Provided