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

August 21, 2026 updated by: Nuvalent Inc.

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

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. Following FDA Approval of zidesamtinib on 22 July 2026, the Expanded Access Program is closed in the United States (US); however, it remains open at all non-US sites listed on ClinicalTrials.gov.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

The purpose of this Expanded Access Program is to provide access to zidesamtinib (NVL-520) an investigational therapy for eligible patients with ROS1 fusion-positive advanced non- small cell lung cancer (ROS1+ NSCLC) who have previously received ≥ 1 prior ROS1 tyrosine kinase inhibitor (TKI) or eligible patients with other ROS1-positive solid tumors who have previously received any prior commercially-available or investigational therapy, and lack satisfactory therapeutic alternatives and are unable to access zidesamtinib through a clinical trial. Following FDA Approval of zidesamtinib on 22 July 2026, the Expanded Access Program is closed in the United States (US); however, it remains open at all non-US sites listed on ClinicalTrials.gov.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Available
        • Chris O'Brien Lifehouse
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Available
        • Peter MacCallum Cancer Centre
  • Belgium
      • Leuven, Belgium, 3000
        • Available
        • UZLeuven
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Available
        • Cross Cancer Institute
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Available
        • Princess Margaret Hospital
  • France
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69008
        • Available
        • Centre Leon Berard
    • Occitanie
      • Toulouse, Occitanie, France, 31059
        • Available
        • GCS IUCT Oncopole
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44800
        • Available
        • CHU de Nantes
    • Île-de-France Region
      • Villejuif, Île-de-France Region, France, 94800
        • Available
        • Institut Gustave Roussy
  • Italy
      • Bari, Italy, 70124
        • Available
        • IRCCS Istituto Tumori Giovanni Paolo II
      • Milan, Italy, 20141
        • Available
        • L'Istituto Europeo di Oncologia S.r.l.
      • Milan, Italy, 20133
        • Available
        • FONDAZIONE IRCCS Istituto Nazionale dei Tumori
      • Padova, Italy, 35128
        • Available
        • IRCCS Istituto Oncologico Veneto
      • Ravenna, Italy, 48121
        • Available
        • AUSL della Romagna - Ravenna
      • Roma, Italy, 00144
        • Available
        • Istituto Nazionale Tumori "Regina Elena
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Available
        • Netherlands Cancer Institute: NKI
      • Amsterdam, Netherlands, 1006 BE
        • Available
        • Antoni van Leeuwenhoek Hospital
      • Groningen, Netherlands, 9713 GZ
        • Available
        • University Medical Center Groningen
  • Singapore
      • Singapore, Singapore, 168583
        • Available
        • National Cancer Centre Singapore
      • Singapore, Singapore, 119074
        • Available
        • National University Hospital Singapore
  • Spain
      • Barcelona, Spain, 08017
        • Available
        • UOMI Cancer Center-Clinica Tres Torres
      • Barcelona, Spain, 08035
        • Available
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spain, 28007
        • Available
        • Gregorio Marañón General University Hospital
      • Madrid, Spain, 28041
        • Available
        • Hospital Univ Doce de Octubre
  • Taiwan
      • Taichung, Taiwan, 402306
        • Available
        • Chung Shan Medical University
      • Tainan, Taiwan, 70403
        • Available
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100229
        • Available
        • National Taiwan University Hospital
  • United Kingdom
      • London, United Kingdom, SM2 5PT
        • Available
        • The Royal Marsden Hospital
      • Manchester, United Kingdom, M20 4BX
        • Available
        • The Christie Hospital
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Available
        • The Royal Marsden Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years.
  2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumor with documented ROS1 rearrangement.
  3. Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
  4. Enrollment in a clinical trial of zidesamtinib is not possible.
  5. Adequate organ function and bone marrow reserve.

Exclusion Criteria:

  1. Prior receipt of zidesamtinib.
  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.
  4. Eligible for ongoing clinical trial with zidesamtinib

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvalent Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

January 28, 2025

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVL-520-EAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe