Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
NVL-655-EAP
Expanded Access Treatment of Neladalkib (NVL-655) in Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
1 other identifier
expanded_access
N/A
12 countries
44
Brief Summary
The Expanded Access Program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2025
CompletedFirst Posted
Study publicly available on registry
February 19, 2025
CompletedMay 7, 2026
January 1, 2026
February 11, 2025
May 1, 2026
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumors with a documented ALK rearrangement or activating ALK mutation.
- 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.
- Enrollment in a clinical trial of neladalkib is not possible.
- Adequate organ function and bone marrow reserve.
You may not qualify if:
- Prior receipt of neladalkib.
- Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.
- Ongoing anti-cancer therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nuvalent Inc.lead
Study Sites (44)
University Of California Irvine Medical Center
Orange, California, 92868, United States
University of Colorado Anschutz School of Medicine
Aurora, Colorado, 80045, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Henry Ford Cancer Institute
Detroit, Michigan, 48202, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
NYU Langone Health
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University
Durham, North Carolina, 27708, United States
The Ohio State University
Columbus, Ohio, 43210, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Washington / Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Cross Cancer Institute
Edmonton, Alberta, AB T6G 1Z2, Canada
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
Princess Margaret Hospital
Toronto, Ontario, ON M5G 2M9, Canada
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, 69008, France
GCS IUCT Oncopole
Toulouse, Occitanie, 31059, France
CHU de Nantes
Nantes, Pays de la Loire Region, 44800, France
Institut Gustave Roussy
Villejuif, Île-de-France Region, 94800, France
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
L'Istituto Europeo di Oncologia S.r.l.
Milan, 20141, Italy
IRCCS Istituto Oncologico Veneto
Padova, 35128, Italy
AUSL della Romagna - Ravenna
Ravenna, 48121, Italy
IRCCS Istituto Nazionale Tumori Regina Elena
Rome, 53, Italy
Stichting Het Nederlands Kanker Instituut
Amsterdam, North Holland, 1066 CX, Netherlands
Antoni van Leeuwenhoek Hospital
Amsterdam, 1006 BE, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
National University Hospital Singapore
Singapore, 119074, Singapore
National Cancer Centre Singapore
Singapore, 168583, Singapore
Seoul National University Hospital
Seoul, Jongno-gu, 03080, South Korea
Gerencia de Gestión Integrada A Coruna
A Coruña, 15006, Spain
Uomi Cancer Center-Clinica Tres Torres
Barcelona, 08017, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Kantonsspital Luzern
Lucerne, 6000, Switzerland
Ospedale Italiano di Lugano
Viganello, 6962, Switzerland
National Cheng-Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
The Royal Marsden Hospital
London, UK, SW3 6JJ, United Kingdom
The Christie Hospital
Manchester, M20 4BX, United Kingdom