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

Status

Indicates the current recruitment status or the expanded access status.
Available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings