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New ALK inhibitor NVL-655 enters trials for Hard-to-Treat cancers

NCT ID NCT05384626

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new drug called neladalkib (NVL-655) in people with advanced ALK-positive non-small cell lung cancer and other solid tumors. The trial has two parts: Phase 1 finds the safest dose, and Phase 2 checks how well it shrinks tumors. Up to 840 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Neladalkib (NVL-655)
What this could lead to
If successful, this could provide a new treatment option for people with ALK-positive cancers that have stopped responding to other therapies.
What could go wrong
This is an early-phase trial, so the drug may not work as hoped or could cause unexpected side effects. Results may not apply to all patients.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 840 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Jan 2028

An estimate. End dates often move.

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

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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, Phase 2 Cohort 2f only: Age ≥12 years and weighing \>40 kg. DDI sub-study Cohorts G and H only: age 18-60 years, inclusive 2. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation. 3. Phase 2 1. Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement 2. Phase 2 Cohort 2f: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation detected by certified assay. 4. DDI sub-study cohorts: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement 5. DDI sub-study cohorts: Must have previously received ≥1 ALK TKI; no prior investigational agents targeting ALK; any number of prior chemotherapy and/or immunotherapy 6. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1 Phase 2: Must have measurable disease according to RECIST 1.1 7. Adequate organ function and bone marrow reserve Exclusion criteria: 1. Patient's cancer has a known oncogenic driver alteration other than ALK. 2. Known allergy/hypersensitivity to excipients of NVL-655. 3. Major surgery within 4 weeks of the study entry 4. Ongoing or anticancer therapy 5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

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

Locally advanced solid tumor Metastatic solid tumor

How to take part

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

  1. The places running it

    73 sites in 15 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

  • Azienda Ospedaliera Universitaria Ospedali Riuniti Umberto

    RECRUITING

    Ancona, 60126, Italy

  • BC Cancer Center

    RECRUITING

    Vancouver, British Columbia, VZ 4E6, Canada

  • Cancer Institute Hospital of JFCR

    RECRUITING

    Tokyo, 1358550, Japan

  • Centre Leon Berard

    RECRUITING

    Lyon, 69373, France

  • Chu De Nantes

    RECRUITING

    Nantes, 44093, France

  • Chung-Shan Medical University Hospital

    RECRUITING

    Taichung, 402306, Taiwan

  • Complejo Hospitalario Universitario de A Coruna

    RECRUITING

    A Coruña, 15006, Spain

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Edinburgh Cancer Centre

    RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Georgetown University Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Henry Ford Cancer Institute

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital General Universitario Gregorio Maranon

    RECRUITING

    Madrid, 28009, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • IRCCS Istituto Tumori "G. Paolo II"

    RECRUITING

    Bari, 70124, Italy

  • Institut Claudius Regaud

    RECRUITING

    Toulouse, 31059, France

  • Institute Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Instituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Instituto Oncologico Veneto

    RECRUITING

    Padova, 35128, Italy

  • Istituto Oncologico Svizzera Italiana

    RECRUITING

    Bellinzona, 6500, Switzerland

  • John Hopkins University

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Kanagawa Cancer Center

    RECRUITING

    Kanagawa, 2418515, Japan

  • Kindai University Hospital

    RECRUITING

    Osaka, 5898511, Japan

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • LungenClinic Grosshansdorf GmbH

    RECRUITING

    Großhansdorf, 22927, Germany

  • Luzerner Kantonsspital

    RECRUITING

    Lucerne, 6000, Switzerland

  • MD Anderson Cancer Center

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • National Cancer Center

    RECRUITING

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, 1040051, Japan

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • National University Hospital

    RECRUITING

    Singapore, Singapore, 119074, Singapore

  • OSU Brain & Spine Hospital

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Okayama University Hospital

    RECRUITING

    Okayama, 7008558, Japan

  • Ospedale Santa Maria delle Croci

    RECRUITING

    Ravenna, 48100, Italy

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 0A3, Canada

  • Regina Elena Institute for Cancer Research

    RECRUITING

    Rome, 00144, Italy

  • Royal Marsden Hospital

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Royal North Shore Hospital

    RECRUITING

    Sydney, New South Wales, 2065, Australia

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Sarah Cannon

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Shizuoka Cancer Center

    RECRUITING

    Shizuoka, 4118777, Japan

  • Stanford Cancer Institute

    RECRUITING

    Stanford, California, 94305, United States

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Netherlands Cancer Institute

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • The Ottawa Hospital Cancer Center

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • The Royal Marsden - Chelsea

    RECRUITING

    London, SM2 5PT, United Kingdom

  • UOMI Cancer Center

    RECRUITING

    Barcelona, 08017, Spain

  • Universitair Ziekenhuis Antwerpen (UZA)

    RECRUITING

    Antwerp, 2650, Belgium

  • Universitaire Ziekenhuizen Leuven Campus Gastthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • Universitatsklinikum Koln - University Hospital Cologne

    RECRUITING

    Cologne, 50937, Germany

  • University Medical Center Groningen (UMCG)

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • University of California Irvine Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • University of California, Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Miami; Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Pennsylvania, Abramson Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Universitätsklinikum Frankfurt

    RECRUITING

    Frankfurt, 60590, Germany

  • Universkitatsklinikum Heidelberg - University Hospital Heidelberg

    RECRUITING

    Heidelberg, 69126, Germany

  • Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Wakayama Medical University Hospital

    RECRUITING

    Wakayama, 6418510, Japan

  • Washington University School of Medicine Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63310, United States

  • Winship Cancer Institute, Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

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