Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors

Available (expanded access)

Conditions studied: Non Small Cell Lung Cancer, ROS1-positive Non-Small Cell Lung Cancer (NSCLC)

In brief

The Expanded Access Program will provide an alternate mechanism for these patients, who lack satisfactory therapeutic alternatives and cannot participate in a zidesamtinib clinical trial, to access investigational zidesamtinib.

Key facts

Study ID

NCT06797362

Run by

Nuvalent Inc.

Last updated by the study team

2026-06-15

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 tumor with documented ROS1 rearrangement.
• Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
• Enrollment in a clinical trial of zidesamtinib is not possible.
• Adequate organ function and bone marrow reserve.

You may not qualify if…

• Prior receipt of zidesamtinib.
• Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.
• Ongoing anti-cancer therapy.
• Eligible for ongoing clinical trial with zidesamtinib

Where it is running

• 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
• Memorial Sloan Kettering Cancer Center — Manhattan, New York, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Washington / Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• UZLeuven — Leuven, Belgium
• Cross Cancer Institute — Edmonton, Alberta, 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
• IRCCS Istituto Tumori Giovanni Paolo II — Bari, Italy
• L'Istituto Europeo di Oncologia S.r.l. — Milan, Italy
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy
• IRCCS Istituto Oncologico Veneto — Padova, Italy
• AUSL della Romagna - Ravenna — Ravenna, Italy
• Istituto Nazionale Tumori "Regina Elena — Roma, Italy
• Antoni van Leeuwenhoek Hospital — Amsterdam, Netherlands
• Netherlands Cancer Institute: NKI — Amsterdam, Netherlands
• University Medical Center Groningen — Groningen, Netherlands

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.