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New hope for rare lung cancer: targeted pill NVL-330 enters human trials

NCT ID NCT06521554

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tests a new oral drug, NVL-330, in about 200 adults with advanced or metastatic non-small cell lung cancer that has specific HER2 mutations. The goal is to find the safest and most effective dose and see if the drug can shrink tumors. Participants must have HER2-altered lung cancer and measurable disease.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 200 people

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

Started

Jul 2024

Expected to finish

Feb 2027

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

18 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 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC 3. Documented HER2 status as follows: 1. Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants or HER2 amplification. 2. Phase 1b: Documented oncogenic HER2 mutation. 4. Identification of lesions as follows: 1. Phase 1a: Must have evaluable disease (target or nontarget) according to RECIST 1.1. 2. Phase 1b: Must have measurable disease, defined as ≥ 1 radiologically measurable target lesion according to RECIST 1.1. 5. Adequate organ function and bone marrow reserve Exclusion Criteria: 1. Participant's cancer has known oncogenic driver alteration other than HER2 2. Known allergy/hypersensitivity to excipients of NVL-330 3. Major surgery within 4 weeks of the first dose of study drug 4. Ongoing or recent 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

    21 sites in 3 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

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, New South Wales, NSW 2050, Australia

  • City of Hope - Lennar

    RECRUITING

    Irvine, California, 92618, United States

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • 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 Center

    RECRUITING

    Detroit, Michigan, 48242, United States

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayview Medical Center

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • North Shore Health Hub

    RECRUITING

    Saint Leonards, New South Wales, 2065, Australia

  • OSU Brain and Spine Hospital

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Princess Margaret Cancer Center - University Health Network

    RECRUITING

    Toronto, Ontario, M5G 1L7, Canada

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute at HealthONE

    RECRUITING

    Denver, Colorado, 80218, United States

  • Sibley Memorial Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • Stanford Cancer Institute

    RECRUITING

    Stanford, California, 94305, United States

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of California, Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

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