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New targeted drug shows promise for Hard-to-Treat lung cancer

NCT ID NCT06593522

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new drug called anvumetostat in people with a specific genetic form of advanced non-small cell lung cancer (MTAP-deleted NSCLC) that has worsened after prior treatment. The main goals are to see if the drug shrinks tumors and to check its safety. About 61 participants will receive one of two dose levels of the drug.

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

61 people

The number who actually took part.

Started

Dec 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 99 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: * Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP) NSCLC * Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease. * Either an archival tissue sample or an archival block must be available. * Life expectancy of greater than 3 months, in the opinion of the investigator. * Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible. * Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible. Exclusion Criteria: Disease Related • Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2/ERBB2), KRAS proto-oncogene G12C (KRAS G12C). Other Medical Conditions * Major surgery within 28 days of study day 1. * Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

MTAP-deleted NSCLC

Contacts and locations

Locations

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Adana, 01370, Turkey (Türkiye)

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681, Japan

  • Ajou University Hospital

    Suwon-si Gyeonggi-do, 16499, South Korea

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800, Turkey (Türkiye)

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214, Turkey (Türkiye)

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Beijing Chest Hospital, Capital Medical University

    Beijing, 101149, China

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, 2298, Australia

  • Cancer Research South Australia

    Adelaide, South Australia, 5000, Australia

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centro Paulista de Oncologia

    São Paulo, 04538-132, Brazil

  • Cha Bundang Medical Center, Cha University

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • 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

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360, United States

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD, Netherlands

  • Fakultni Thomayerova nemocnice

    Prague, 140 59, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Fund Faculdade Regional Med Sao Jose Rio Preto

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

  • Fundacao Antonio Prudente - Hosp AC Camargo

    São Paulo, São Paulo, 01509-900, Brazil

  • Fundacao Champalimaud

    Lisbon, 1400-038, Portugal

  • Fundacao pio xII Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560, Turkey (Türkiye)

  • GenesisCare -North Shore Oncology

    St Leonards, New South Wales, 2065, Australia

  • Hartford HealthCare Cancer Institute - Manchester

    Plainville, Connecticut, 06062, United States

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450001, China

  • Hopitaux Universitaires de Geneve

    Geneva, 1211, Switzerland

  • Hospital Cuf porto

    Porto, 4100-180, Portugal

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91010-004, Brazil

  • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072, Portugal

  • Instituto de Educacao Pesquisa e Gestao em Saude

    Rio de Janeiro, 22775-001, Brazil

  • Instituto do Cancer Estado SP Icesp

    São Paulo, São Paulo, 01246-000, Brazil

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012, China

  • Jinan Central Hospital

    Jinan, Shandong, 250013, China

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007, Switzerland

  • Liga Norte-Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59062-000, Brazil

  • London Health Sciences Centre

    London, Ontario, N6A 4L6, Canada

  • Masarykuv onkologicky ustav

    Brno, 656 53, Czechia

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101, Australia

  • McGill University Health Centre Glen Site

    Montreal, Quebec, H4A 3J1, Canada

  • Medstar Georgetown University Hospital

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

  • Memorial Bahcelievler Hastanesi

    Istanbul, 34180, Turkey (Türkiye)

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028, China

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cancer Centre Singapore

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

    Amsterdam, 1066 CX, Netherlands

  • Núcleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-110, Brazil

  • Our Lady of the Lake Cancer Institute

    Baton Rouge, Louisiana, 70808, United States

  • Pauls Stradins Clinical University Hospital

    Riga, 1002, Latvia

  • 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

  • Riga East Clinical University Hospital

    Riga, 1079, Latvia

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute

    Dallas, Texas, 75230, United States

  • Sarah Cannon Research Institute Oncology Partners

    Nashville, Tennessee, 37203, United States

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123, China

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Sint Jansdal Ziekenhuis

    Harderwijk, 3844 DG, Netherlands

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas, 75246, United States

  • Texas Oncology Central/South Texas

    Austin, Texas, 78745, United States

  • Texas Oncology Northeast Texas

    Tyler, Texas, 75702, United States

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550, Japan

  • The Catholic University of Korea St Vincents Hospital

    Suwon-si, Gyeonggi-do, 16247, South Korea

  • The First Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • Trinity Health Saint Joseph Mercy Ann Arbor

    Ann Arbor, Michigan, 48106, United States

  • US Oncology Research Investigational Products Center

    Irving, Texas, 75063, United States

  • Unidade Local de Saude de Braga, EPE

    Braga, 4710-243, Portugal

  • 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

  • Universitaetsspital Basel

    Basel, 4031, Switzerland

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067, United States

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031, United States

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08, Czechia

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510, Japan

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041, China

  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7, Canada

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005, China