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New targeted pill shows promise for Hard-to-Treat lung cancers

NCT ID NCT05118789

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 zidesamtinib (NVL-520) for people with advanced lung cancer or other solid tumors that have a specific genetic change (ROS1-positive). The goal is to find the best dose and see how well it shrinks tumors. About 359 adults will take part in two phases: first to check safety, then to measure effectiveness.

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 359 people

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

Started

Jan 2022

Expected to finish

Dec 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 (Cohort 2e only: Age ≥12 years). 2. Disease Criteria: 1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement. 2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement. 3. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement. 3. Prior anticancer treatment (except cohort 2a). 4. 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. 5. Adequate baseline organ function and bone marrow reserve. Exclusion Criteria: 1. Patient's cancer has a known oncogenic driver alteration other than ROS1. 2. Known allergy/hypersensitivity to excipients of NVL-520. 3. Major surgery within 4 weeks of first dose of study drug. 4. Ongoing 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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    62 sites in 14 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Atrium Health Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • CHU de Nantes

    RECRUITING

    Nantes, 44000, France

  • Centre Legon Berard

    RECRUITING

    Lyon, 69008, France

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Chung Shan Medical University Hospital

    RECRUITING

    Taichung, 40201, Taiwan

  • Claudius Regaud Institute

    RECRUITING

    Toulouse, 31300, France

  • Cologne University Hospital

    RECRUITING

    Cologne, Germany

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Georgetown University Medical Center

    RECRUITING

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

  • Gregorio Marañón Hospital

    RECRUITING

    Madrid, 28007, Spain

  • Henry Ford Cancer Institute

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • IRCCS Istituto Tumori Giovanni Paolo II

    RECRUITING

    Bari, 70124, Italy

  • Institute Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Istituto Nazionale Tumori Regina Elena

    RECRUITING

    Rome, 00128, Italy

  • Istituto Oncologico Veneto

    RECRUITING

    Padova, 35128, Italy

  • Kanagawa Cancer Center

    RECRUITING

    Kanagawa, 241-8515, Japan

  • Kindai University Hospital

    RECRUITING

    Osaka, 577-8502, Japan

  • MD Anderson Cancer Center

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Mass General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NEXT Oncology - Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • National Cancer Center

    RECRUITING

    Gyeonggi-do, 10408, South Korea

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, 104-0045, Japan

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • National University Hospital Singapore

    RECRUITING

    Singapore, 119074, Singapore

  • Netherlands Cancer Institute

    RECRUITING

    Amsterdam, 1066, Netherlands

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Okayama University Hospital

    RECRUITING

    Okayama, 700-8558, Japan

  • Ospedale Santa Maria delle Croci

    RECRUITING

    Ravenna, 48121, Italy

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Cancer Research

    RECRUITING

    Toronto, Ontario, M5GG 1L7, Canada

  • Royal Marsden Hospital

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Shizuoka Cancer Center

    RECRUITING

    Shizuoka, 411-8777, Japan

  • Stanford Medicine

    RECRUITING

    Palo Alto, California, 94305, United States

  • The Cancer Institute Hospital Of JFCR

    RECRUITING

    Tokyo, 135-8550, Japan

  • UC Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UCI Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • UOMI Cancer Center - Clinica Tres Torres

    RECRUITING

    Barcelona, 08017, Spain

  • University Hospital Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University Hospital of A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • University Medical Centre Groningen

    RECRUITING

    Groningen, Netherlands

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado Cancer Center

    RECRUITING

    Denver, Colorado, 80045, United States

  • University of Miami

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • University of Washington / Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Università Politecnica Marche

    RECRUITING

    Ancona, 60121, Italy

  • Vall d'Hebron University Hospital

    RECRUITING

    Barcelona, 08035, Spain

  • Wakayama Medical University Hospital

    RECRUITING

    Wakayama, 641-8510, Japan

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

More trials for these conditions

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