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New drug targets Hard-to-Treat lung cancer in early trial

NCT ID NCT06855771

Disease control Sponsor: Bristol-Myers Squibb 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This phase 2 trial tests a drug called navlimetostat in about 130 people with advanced or metastatic non-small cell lung cancer that has a specific genetic change (MTAP deletion) and has worsened after other treatments. The main goal is to see if the drug can shrink tumors. Researchers will also monitor safety and how long any benefit lasts.

What this could mean

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

Active substance
Navlimetostat (BMS-986504)
What this could lead to
If successful, this could offer a new treatment option for people with a specific type of advanced lung cancer that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial with only 130 participants, so results may not apply to everyone. The drug may not shrink tumors or could cause side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 182 people

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

Started

Sep 2025

Expected to finish

Dec 2031

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 * Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation. * Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition). * At least 1 measurable lesion as per RECIST v1.1. * Documented radiographic disease progression on or after the most recent line of treatment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF. * Capability to swallow tablets intact (without chewing or crushing). * For combination arms 1. Participants must have documented evidence of EGFR status. 2. Participants with EGFR mutant or wild type NSCLC are allowed. Exclusion Criteria * Active brain metastases or carcinomatous meningitis. * History of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications. * Prior treatment with a PRMT5 or MAT2A inhibitor. * Known severe hypersensitivity to study treatment and/or any of its excipients. * For combination arms a. Prior therapy with iza-bren or any other antibody and/or ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload, except amivantamab. * Other protocol-defined inclusion/exclusion criteria apply.

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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.

Carcinoma, non-small-cell lung

How to take part

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

  1. The places running it

    65 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

  • AOU della Campania Luigi Vanvitelli

    RECRUITING

    Naples, Campania, 80131, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Milano, 20162, Italy

  • Beijing Chest Hospital,Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 101149, China

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

    RECRUITING

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

  • Centrul de Diagnostic si Tratament Provita

    RECRUITING

    Bucharest, 020335, Romania

  • Centrul de Oncologie "Sfântul Nectarie"

    RECRUITING

    Craiova, Dolj, 200542, Romania

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Chu Grenoble Alpes

    RECRUITING

    La Tronche, Isère, 38700, France

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • Fondazione IRCCS San Gerardo dei Tintori

    RECRUITING

    Monza, Lombardy, 20900, Italy

  • Fred Hutchison Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Gabrail Cancer Center

    RECRUITING

    Canton, Ohio, 44718, United States

  • GenesisCare - Campbelltown

    RECRUITING

    Campbelltown, New South Wales, 2560, Australia

  • Groupe hospitalier Paris saint Joseph

    RECRUITING

    Paris, Île-de-France Region, 75014, France

  • Guangxi Medical University Affiliated Tumor Hospital

    RECRUITING

    Nanning, Guangxi, 530201, China

  • H.R.U Málaga - Hospital General

    RECRUITING

    Málaga, 29011, Spain

  • Hopitaux Universitaires Paris Centre-Hopital Cochin

    RECRUITING

    Paris, 75014, France

  • Hospices Civils de Lyon - Hopital Louis Pradel

    RECRUITING

    Bron, Rhône, 69677, France

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

    RECRUITING

    Saint-Herblain, Loire-Atlantique, 44800, France

  • Hôpital Tenon

    RECRUITING

    Paris, 75970, France

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    RECRUITING

    Bologna, 40138, Italy

  • Institut Català d'Oncologia - L'Hospitalet

    RECRUITING

    Hospitalet, Barcelona [Barcelona], 08907, Spain

  • Institut Curie

    RECRUITING

    Paris, 75248, France

  • Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"

    RECRUITING

    Bucharest, Bucharest, 022338, Romania

  • Institutul Oncologic Cluj

    RECRUITING

    Cluj-Napoca, 400015, Romania

  • Institutul Regional de Oncologie

    RECRUITING

    Iași, 700483, Romania

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    RECRUITING

    Naples, Campania, 80131, Italy

  • Istituto Oncologico Veneto IRCCS

    RECRUITING

    Padova, Veneto, 35128, Italy

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Karolinska Universitetssjukhuset Solna

    RECRUITING

    Solna, Stockholms Län [se-01], 171 64, Sweden

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    RECRUITING

    München, Bavaria, 81377, Germany

  • Krankenhaus Martha-Maria Halle-Dölau

    RECRUITING

    Halle, Saxony-Anhalt, 06120, Germany

  • LinYi Cancer Hospital

    RECRUITING

    Linyi, Shandong, 276001, China

  • Local Institution - 0088

    COMPLETED

    Anchorage, Alaska, 99508, United States

  • Local Institution - 0097

    COMPLETED

    Adelaide, South Australia, 5000, Australia

  • Mazowiecki Szpital Onkologiczny

    RECRUITING

    Wieliszew, Masovian Voivodeship, 05-135, Poland

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

  • Queen Elizabeth Hospital Birmingham

    RECRUITING

    Birmingham, England, B15 2TH, United Kingdom

  • S.C. Centrul de Oncologie Euroclinic S.R.L.

    RECRUITING

    Iași, 700106, Romania

  • SC Radiotherapy Center Cluj SRL

    RECRUITING

    Florești, Cluj, 407280, Romania

  • Sahlgrenska Universitetssjukhuset

    RECRUITING

    Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden

  • Sarah Cannon Research Institute UK

    RECRUITING

    London, London, City of, w1g 6ad, United Kingdom

  • Sendai Kousei Hospital

    RECRUITING

    Sendai, Miyagi, 9810914, Japan

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • Szpital Specjalistyczny w Prabutach Spolka z o.o.

    RECRUITING

    Prabuty, 82-550, Poland

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Linhai, Zhejiang, 317000, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • Universitaetsklinikum Koeln

    RECRUITING

    Cologne, 50937, Germany

  • Universitaetsklinikum Wuerzburg

    RECRUITING

    Würzburg, 97080, Germany

  • Universitätsklinikum Frankfurt Goethe-Universität

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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