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

Available

Conditions

Intervention / Treatment

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

Expanded Access

Expanded Access Type

  • 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 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

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

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

February 11, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 19, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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