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Last-Resort drug access opens for ALK-Positive cancer patients

NCT ID NCT06834074

Disease control Sponsor: Nuvalent Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This program offers early access to the investigational drug neladalkib for people with advanced ALK-positive lung cancer or other ALK-positive solid tumors who have run out of standard treatment options and cannot join a clinical trial. Participants must be at least 18 years old and have already tried at least one ALK-targeted therapy. The goal is to provide a potential treatment option when no others are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALK-positive non-small cell lung cancer (NSCLC) Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AUSL della Romagna - Ravenna

    AVAILABLE

    Ravenna, 48121, Italy

  • Antoni van Leeuwenhoek Hospital

    AVAILABLE

    Amsterdam, 1006 BE, Netherlands

  • Azienda Ospedaliero Universitaria delle Marche

    AVAILABLE

    Ancona, 60126, Italy

  • BC Cancer - Vancouver

    AVAILABLE

    Vancouver, British Columbia, V5Z 4E6, Canada

  • CHU de Nantes

    AVAILABLE

    Nantes, Pays de la Loire Region, 44800, France

  • Centre Leon Berard

    AVAILABLE

    Lyon, Auvergne-Rhône-Alpes, 69008, France

  • Chung Shan Medical University

    AVAILABLE

    Taichung, 402306, Taiwan

  • Cross Cancer Institute

    AVAILABLE

    Edmonton, Alberta, AB T6G 1Z2, Canada

  • Dana-Farber Cancer Institute

    AVAILABLE

    Boston, Massachusetts, 02215, United States

  • Duke University

    AVAILABLE

    Durham, North Carolina, 27708, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    AVAILABLE

    Milan, 20133, Italy

  • GCS IUCT Oncopole

    AVAILABLE

    Toulouse, Occitanie, 31059, France

  • Gerencia de Gestión Integrada A Coruna

    AVAILABLE

    A Coruña, 15006, Spain

  • Henry Ford Cancer Institute

    AVAILABLE

    Detroit, Michigan, 48202, United States

  • Hospital Universitario 12 de Octubre

    AVAILABLE

    Madrid, 28041, Spain

  • Hospital Universitario Vall d'Hebron

    AVAILABLE

    Barcelona, 08035, Spain

  • IRCCS Istituto Nazionale Tumori Regina Elena

    AVAILABLE

    Rome, 53, Italy

  • IRCCS Istituto Oncologico Veneto

    AVAILABLE

    Padova, 35128, Italy

  • Institut Gustave Roussy

    AVAILABLE

    Villejuif, Île-de-France Region, 94800, France

  • Kantonsspital Luzern

    AVAILABLE

    Lucerne, 6000, Switzerland

  • L'Istituto Europeo di Oncologia S.r.l.

    AVAILABLE

    Milan, 20141, Italy

  • Massachusetts General Hospital

    AVAILABLE

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    AVAILABLE

    New York, New York, 10065, United States

  • NYU Langone Health

    AVAILABLE

    New York, New York, 10016, United States

  • National Cancer Centre Singapore

    AVAILABLE

    Singapore, 168583, Singapore

  • National Cheng-Kung University Hospital

    AVAILABLE

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    AVAILABLE

    Taipei, 100, Taiwan

  • National University Hospital Singapore

    AVAILABLE

    Singapore, 119074, Singapore

  • Ospedale Italiano di Lugano

    AVAILABLE

    Viganello, 6962, Switzerland

  • Peter MacCallum Cancer Centre

    AVAILABLE

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Hospital

    AVAILABLE

    Toronto, Ontario, ON M5G 2M9, Canada

  • Royal North Shore Hospital

    AVAILABLE

    St Leonards, New South Wales, 2065, Australia

  • Seoul National University Hospital

    AVAILABLE

    Seoul, Jongno-gu, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    AVAILABLE

    Seoul, 03722, South Korea

  • Stichting Het Nederlands Kanker Instituut

    AVAILABLE

    Amsterdam, North Holland, 1066 CX, Netherlands

  • The Christie Hospital

    AVAILABLE

    Manchester, M20 4BX, United Kingdom

  • The Ohio State University

    AVAILABLE

    Columbus, Ohio, 43210, United States

  • The Ottawa Hospital

    AVAILABLE

    Ottawa, Ontario, K1H 8L6, Canada

  • The Royal Marsden Hospital

    AVAILABLE

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The Royal Marsden Hospital

    AVAILABLE

    London, UK, SW3 6JJ, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    AVAILABLE

    Houston, Texas, 77030, United States

  • University Medical Center Groningen

    AVAILABLE

    Groningen, 9713 GZ, Netherlands

  • University Of California Irvine Medical Center

    AVAILABLE

    Orange, California, 92868, United States

  • University of Chicago Medical Center

    AVAILABLE

    Chicago, Illinois, 60637, United States

  • University of Colorado Anschutz School of Medicine

    AVAILABLE

    Aurora, Colorado, 80045, United States

  • University of Washington / Fred Hutchinson Cancer Center

    AVAILABLE

    Seattle, Washington, 98109, United States

  • Uomi Cancer Center-Clinica Tres Torres

    AVAILABLE

    Barcelona, 08017, Spain

  • Washington University in St. Louis

    AVAILABLE

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.