CClinicalTrials.gg
AvailableNCT06834074NVL-655-EAPUpdated Sep 21, 2026

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

An expanded access record providing NVL-655 in Non Small Cell Lung Cancer and ALK-positive Non-small Cell Lung Cancer (NSCLC), sponsored by Nuvalent Inc.. Available at 50 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Nuvalent Inc. · Expanded access

Study type
Expanded access
Access type
Intermediate-size population
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Non Small Cell Lung Cancer
  • ALK-positive Non-small Cell Lung Cancer (NSCLC)

Keywords

  • ALK-positive Solid Tumors
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

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

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.
04

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • DrugNVL-655

    Drug: NVL-655

    Also known as: Neladalkib

05

Where to request access

50 of 50 sites recruiting
  • University Of California Irvine Medical Center
    Orange, California 92868, United States
    Available
  • University of Colorado Anschutz School of Medicine
    Aurora, Colorado 80045, United States
    Available
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
    Available
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Available
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    Available
  • Henry Ford Cancer Institute
    Detroit, Michigan 48202, United States
    Available
  • Washington University in St. Louis
    St Louis, Missouri 63110, United States
    Available
  • NYU Langone Health
    New York, New York 10016, United States
    Available
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Available
  • Duke University
    Durham, North Carolina 27708, United States
    Available
  • The Ohio State University
    Columbus, Ohio 43210, United States
    Available
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Available
  • University of Washington / Fred Hutchinson Cancer Center
    Seattle, Washington 98109, United States
    Available
  • Royal North Shore Hospital
    St Leonards, New South Wales 2065, Australia
    Available
  • Princess Alexandra Hospital
    Woolloongabba, Queensland 4102, Australia
    Available
  • Peter MacCallum Cancer Centre
    Melbourne, Victoria 3000, Australia
    Available
  • Cross Cancer Institute
    Edmonton, Alberta AB T6G 1Z2, Canada
    Available
  • BC Cancer - Vancouver
    Vancouver, British Columbia V5Z 4E6, Canada
    Available
  • The Ottawa Hospital
    Ottawa, Ontario K1H 8L6, Canada
    Available
  • Princess Margaret Hospital
    Toronto, Ontario ON M5G 2M9, Canada
    Available
  • Centre Leon Berard
    Lyon, Auvergne-Rhône-Alpes 69008, France
    Available
  • GCS IUCT Oncopole
    Toulouse, Occitanie 31059, France
    Available
  • CHU de Nantes
    Nantes, Pays de la Loire Region 44800, France
    Available
  • Institut Gustave Roussy
    Villejuif, Île-de-France Region 94800, France
    Available
  • Azienda Ospedaliero Universitaria delle Marche
    Ancona, 60126, Italy
    Available
  • Istituto Tumori Giovanni Paolo II
    Bari, 70124, Italy
    Available
  • Fondazione IRCCS Istituto Nazionale dei Tumori
    Milan, 20133, Italy
    Available
  • L'Istituto Europeo di Oncologia S.r.l.
    Milan, 20141, Italy
    Available
  • IRCCS Istituto Oncologico Veneto
    Padova, 35128, Italy
    Available
  • AUSL della Romagna - Ravenna
    Ravenna, 48121, Italy
    Available
  • IRCCS Istituto Nazionale Tumori Regina Elena
    Rome, 53, Italy
    Available
  • Stichting Het Nederlands Kanker Instituut
    Amsterdam, North Holland 1066 CX, Netherlands
    Available
  • Antoni van Leeuwenhoek Hospital
    Amsterdam, 1006 BE, Netherlands
    Available
  • University Medical Center Groningen
    Groningen, 9713 GZ, Netherlands
    Available
  • National University Hospital Singapore
    Singapore, 119074, Singapore
    Available
  • National Cancer Centre Singapore
    Singapore, 168583, Singapore
    Available
  • Seoul National University Hospital
    Seoul, Jongno-gu 03080, South Korea
    Available
  • Severance Hospital Yonsei University Health System
    Seoul, 03722, South Korea
    Available
  • Gerencia de Gestión Integrada A Coruna
    A Coruña, 15006, Spain
    Available
  • Uomi Cancer Center-Clinica Tres Torres
    Barcelona, 08017, Spain
    Available
  • Hospital Universitario Vall d'Hebron
    Barcelona, 08035, Spain
    Available
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
    Available
  • Kantonsspital Luzern
    Lucerne, 6000, Switzerland
    Available
  • Ospedale Italiano di Lugano
    Viganello, 6962, Switzerland
    Available
  • Chung Shan Medical University
    Taichung, 402306, Taiwan
    Available
  • National Cheng-Kung University Hospital
    Tainan, 704, Taiwan
    Available
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Available
  • The Royal Marsden Hospital
    Sutton, Surrey SM2 5PT, United Kingdom
    Available
  • The Royal Marsden Hospital
    London, UK SW3 6JJ, United Kingdom
    Available
  • The Christie Hospital
    Manchester, M20 4BX, United Kingdom
    Available
06

Registry details

Key details

Study ID
NCT06834074
Lead sponsor
Nuvalent Inc.
Responsible party
Sponsor
First posted
Feb 19, 2025
Last update
Sep 21, 2026

Study contacts

Contact for Program Information
Contact
MedicineAccess@clinigengroup.com
877 768 4303
View the source record on ClinicalTrials.gov ↗

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