Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors

Available (expanded access)

Conditions studied: Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC)

In brief

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.

Key facts

Study ID

NCT06834074

Run by

Nuvalent Inc.

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• The University of Texas MD Anderson Cancer Center — Houston, Texas, 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
• The Ottawa Hospital — Ottawa, Ontario, 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
• Azienda Ospedaliero Universitaria delle Marche — Ancona, Italy
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.