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

May 12, 2026 updated by: Nuvalent Inc.

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

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.

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 investigational ALK inhibitor, neladalkib (NVL-655), for eligible patients with ALK-positive locally advanced or metastatic NSCLC (ALK+ NSCLC) who have previously received an ALK tyrosine kinase inhibitor (TKI) or eligible patients with other ALK-positive solid tumors, and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.

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.
  • Intermediate-size Population

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
      • St Leonards, New South Wales, Australia, 2065
        • Available
        • Royal North Shore Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Available
        • Peter Maccallum Cancer Centre
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, AB T6G 1Z2
        • Available
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Available
        • BC Cancer - Vancouver
    • Ontario
      • Toronto, Ontario, Canada, ON 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
      • Ancona, Italy, 60126
        • Available
        • Azienda Ospedaliero Universitaria delle Marche
      • 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
      • Rome, Italy, 53
        • Available
        • IRCCS Istituto Nazionale Tumori Regina Elena
  • Netherlands
      • Amsterdam, Netherlands, 1006 BE
        • Available
        • Antoni van Leeuwenhoek Hospital
      • Groningen, Netherlands, 9713 GZ
        • Available
        • University Medical Center Groningen
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1066 CX
        • Available
        • Stichting Het Nederlands Kanker Instituut
  • Singapore
      • Singapore, Singapore, 168583
        • Available
        • National Cancer Centre Singapore
      • Singapore, Singapore, 119074
        • Available
        • National University Hospital Singapore
  • South Korea
    • Jongno-gu
      • Seoul, Jongno-gu, South Korea, 03080
        • Available
        • Seoul National University Hospital
  • Spain
      • A Coruña, Spain, 15006
        • Available
        • Gerencia de Gestión Integrada A Coruna
      • Barcelona, Spain, 08017
        • Available
        • Uomi Cancer Center-Clinica Tres Torres
      • Barcelona, Spain, 08035
        • Available
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spain, 28041
        • Available
        • Hospital Universitario 12 de Octubre
  • Switzerland
      • Lucerne, Switzerland, 6000
        • Available
        • Kantonsspital Luzern
      • Viganello, Switzerland, 6962
        • Available
        • Ospedale Italiano di Lugano
  • Taiwan
      • Tainan, Taiwan, 704
        • Available
        • National Cheng-Kung University Hospital
      • Taipei, Taiwan, 100
        • Available
        • National Taiwan University Hospital
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Available
        • The Christie Hospital
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Available
        • The Royal Marsden Hospital
    • UK
      • London, UK, United Kingdom, SW3 6JJ
        • Available
        • The Royal Marsden Hospital
  • United States
    • California
      • Orange, California, United States, 92868
        • Available
        • University of California Irvine Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Available
        • University of Colorado Anschutz School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Available
        • University of Chicago Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Available
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana-Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Available
        • Henry Ford Cancer Institute
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Available
        • Washington University in St. Louis
    • New York
      • New York, New York, United States, 10065
        • Available
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10016
        • Available
        • NYU Langone Health
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Available
        • Duke University
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Available
        • The Ohio State University
    • Texas
      • Houston, Texas, United States, 77030
        • Available
        • The University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Available
        • University of Washington / Fred Hutchinson Cancer Center

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 tumors with a documented ALK rearrangement or activating ALK mutation.
  3. 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.
  4. Enrollment in a clinical trial of neladalkib is not possible.
  5. Adequate organ function and bone marrow reserve.

Exclusion Criteria:

  1. Prior receipt of neladalkib.
  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.

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).
February 11, 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.
February 11, 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.
February 19, 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.
May 14, 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.
May 12, 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

Keywords

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-655-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.

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