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New drug combo targets rare lung tumor gene defect

NCT ID NCT06333951

Disease control Sponsor: Amgen 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-stage trial is testing a new drug called anvumetostat, alone or with other cancer drugs, in about 49 adults with advanced lung or chest tumors that lack a gene called MTAP. The main goals are to find the safest dose and to see what side effects occur. Researchers will also check if the tumors shrink or stop growing.

What this could mean

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

Active substance
Anvumetostat (AMG 193) alone or with carboplatin, paclitaxel, pembrolizumab, pemetrexed, or sotorasib
What this could lead to
If successful, this could point toward a new treatment option for people with advanced lung or chest tumors that have a specific genetic deletion (MTAP).
What could go wrong
This is an early Phase 1b trial with only 49 participants, so it is primarily testing safety and dosing. It is too early to know if the drug will work, and side effects are possible.

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

49 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Nov 2026

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 to 100 years

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 Subprotocol A, B, and C * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years). * Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before Anvumetostat dosing. * Homozygous MTAP-deletion * Able to swallow and retain PO administered study treatment. * Disease measurable as defined by RECIST v1.1. Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC. Arm A (Anvumetostat + carboplatin + paclitaxel + pembrolizumab): \- Predominantly squamous histology. Arm B (Anvumetostat + carboplatin + pemetrexed + pembrolizumab): \- Predominantly non-squamous histology. Arm C (Anvumetostat + pembrolizumab): \- PD-L1 positive. Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation. Subprotocol C * Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases. * Brain lesion meeting RANO-BM criteria for measurable disease. Exclusion Criteria Subprotocol A, B, and C * Cardiovascular and pulmonary exclusion criteria as defined in the protocol. * Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis). * History of solid organ transplant. * Major surgery within 28 days of first dose of Anvumetostat. * Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor. * Radiation therapy within 28 days of first dose. Subprotocol A \- Autoimmune disease or immunodeficiency disease as defined in the protocol'

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma thoracic cancer

As listed by the trial registrant

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

Non-small cell lung cancer Thoracic tumors

Contacts and locations

Locations

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Adana, 01370, Turkey (Türkiye)

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681, Japan

  • Alexandra Hospital

    Athens, 11528, Greece

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Beneficencia Portuguesa de Sao Paulo - Bp

    São Paulo, São Paulo, 01509-900, Brazil

  • Cemic

    Ciudad Autonoma Buenos Aires, C1431FWO, Argentina

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000, Belgium

  • Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

    Verona, 37126, Italy

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin, 20-701, Poland

  • Cipo - Centro Integrado de Pesquisa em Oncologia

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • City of Hope Orange County Lennar Foundation Cancer Center

    Duarte, California, 91010, United States

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309, United States

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360, United States

  • European Interbalkan Medical Center

    Thessaloniki, 57001, Greece

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Alessandria, 15100, Italy

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fund Faculdade Regional Med Sao Jose Rio Preto

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Futuremeds spolka z ograniczona odpowiedzialnoscia

    Krakow, 31-501, Poland

  • General Hospital Of Thessaloniki Papageorgiou

    Thessaloniki, 56429, Greece

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510000, China

  • Gustave Roussy

    Villejuif, 94805, France

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06230, Turkey (Türkiye)

  • HealthPartners Institute

    Saint Paul, Minnesota, 55102, United States

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102, United States

  • Hopital de la Timone

    Marseille, 13005, France

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629ODT, Argentina

  • IRCCS Istituto Clinico Humanitas

    Rozzano (MI), 20089, Italy

  • Institut Bergonie

    Bordeaux, 33000, France

  • Institut de Cancerologie de l Ouest Rene Gauducheau

    Saint-Herblain, 44805, France

  • Instituto Argentino de Diagnóstico y Tratamiento

    Ciudad Automona de Buenos Aires, Buenos Aires, C1117ABC, Argentina

  • Instituto Cancer Sao Paulo Icesp

    São Paulo, 01246-000, Brazil

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338, Poland

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012, China

  • Medizinische Universitaet Graz

    Graz, 8036, Austria

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020, Austria

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028, China

  • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    Gliwice, 44-102, Poland

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • New York University Grossman School of Medicine

    New York, New York, 10016, United States

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405, United States

  • Oncology Consultants Cancer Center

    Houston, Texas, 77030, United States

  • Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Orange Health Service

    Orange, New South Wales, 2800, Australia

  • Perlmutter Cancer Center at New York University Langone Hospital----Long Island

    New York, New York, 10016, United States

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Shatin, New Territories, Hong Kong

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong, Hong Kong

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA, Netherlands

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 32224, United States

  • Saint Lukes Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas, 75246, United States

  • Texas Oncology Northeast Texas

    Tyler, Texas, 75702, United States

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011, Australia

  • Translational Research in Oncology US Inc, Trio Central Pharmacy

    Los Angeles, California, 90095, United States

  • US Oncology Research Investigational Products Center

    Dallas, Texas, 75246, United States

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee, 37203, United States

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69126, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078, Germany

  • University of California Irvine

    Orange, California, 92868-3217, United States

  • University of California Los Angeles

    Santa Monica, California, 90404, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Tennessee Medical Center Knoxville

    Knoxville, Tennessee, 37920, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Upstate University Hospital

    Syracuse, New York, 13210, United States

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031, United States

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510, Japan

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041, China

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