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MTAP-deleted NSCLCPhase 2NCT06593522

A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)

A Phase 2 study testing anvumetostat in people with MTAP-deleted NSCLC, run by Amgen at 91 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main objective of the study is to characterize safety and efficacy of 2 dose levels of anvumetostat by investigator, and to evaluate anvumetostat monotherapy efficacy by Blinded Independent Central Review (BICR). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
MTAP-deleted NSCLC
What is being tested?
anvumetostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
91 sitesin 16 countries
Study dates
26 Dec 2024to 30 Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

91 sites in 16 countries.

91 sites in 16 countries

United States20 sites

  • Trinity Health Saint Joseph Mercy Ann Arbor

    Ann Arbor, Michigan, 48106

  • Texas Oncology Central/South Texas

    Austin, Texas, 78745

  • Our Lady of the Lake Cancer Institute

    Baton Rouge, Louisiana, 70808

  • Sarah Cannon Research Institute

    Dallas, Texas, 75230

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • City of Hope National Medical Center

    Duarte, California, 91010

  • City of Hope Orange County Lennar Foundation Cancer Center

    Duarte, California, 91010

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • US Oncology Research Investigational Products Center

    Irving, Texas, 75063

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Sarah Cannon Research Institute Oncology Partners

    Nashville, Tennessee, 37203

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee, 37203

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Hartford HealthCare Cancer Institute - Manchester

    Plainville, Connecticut, 06062

  • Texas Oncology Northeast Texas

    Tyler, Texas, 75702

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

China14 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Cancer Hospital

    Beijing, 100142

  • Beijing Chest Hospital, Capital Medical University

    Beijing, 101149

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028

  • The First Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123

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

    Wuhan, Hubei, 430022

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450001

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

Brazil10 sites

  • Fundacao pio xII Barretos

    Barretos, São Paulo, 14784-400

  • Liga Norte-Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59062-000

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

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91010-004

  • Instituto de Educacao Pesquisa e Gestao em Saude

    Rio de Janeiro, 22775-001

  • Núcleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-110

  • Fund Faculdade Regional Med Sao Jose Rio Preto

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

  • Instituto do Cancer Estado SP Icesp

    São Paulo, São Paulo, 01246-000

  • Fundacao Antonio Prudente - Hosp AC Camargo

    São Paulo, São Paulo, 01509-900

  • Centro Paulista de Oncologia

    São Paulo, 04538-132

Other trials in Brazil

Japan6 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

Other trials in Japan

Canada5 sites

  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • London Health Sciences Centre

    London, Ontario, N6A 4L6

  • McGill University Health Centre Glen Site

    Montreal, Quebec, H4A 3J1

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Turkey (Türkiye)5 sites

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Adana, 01370

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Memorial Bahcelievler Hastanesi

    Istanbul, 34180

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

Other trials in Turkey (Türkiye)

Australia4 sites

  • Cancer Research South Australia

    Adelaide, South Australia, 5000

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

  • GenesisCare -North Shore Oncology

    St Leonards, New South Wales, 2065

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, 2298

Other trials in Australia

Czechia4 sites

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Fakultni Thomayerova nemocnice

    Prague, 140 59

Other trials in Czechia

Portugal4 sites

  • Unidade Local de Saude de Braga, EPE

    Braga, 4710-243

  • Fundacao Champalimaud

    Lisbon, 1400-038

  • Hospital Cuf porto

    Porto, 4100-180

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

Other trials in Portugal

South Korea4 sites

  • Cha Bundang Medical Center, Cha University

    Seongnam-si, Gyeonggi-do, 13496

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Ajou University Hospital

    Suwon-si Gyeonggi-do, 16499

  • The Catholic University of Korea St Vincents Hospital

    Suwon-si, Gyeonggi-do, 16247

Other trials in South Korea

Netherlands3 sites

  • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

    Amsterdam, 1066 CX

  • Sint Jansdal Ziekenhuis

    Harderwijk, 3844 DG

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

Other trials in Netherlands

Switzerland3 sites

  • Universitaetsspital Basel

    Basel, 4031

  • Hopitaux Universitaires de Geneve

    Geneva, 1211

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

Taiwan3 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Hong Kong2 sites

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Shatin, New Territories

Other trials in Hong Kong

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    Riga, 1002

  • Riga East Clinical University Hospital

    Riga, 1079

Other trials in Latvia

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • National Cancer Centre Singapore

    Singapore, 168583

Other trials in Singapore

About this study

Official title: A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Anvumetostat in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

The main objective of the study is to characterize safety and efficacy of 2 dose levels of anvumetostat by investigator, and to evaluate anvumetostat monotherapy efficacy by Blinded Independent Central Review (BICR).

Being tested
anvumetostat
Keywords
Oncology, anvumetostat
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anvumetostatDrug

    Film-coated tablet

Study groups in NCT06593522
Study groupRoleWhat they receive
Part 1: Dose EvaluationExperimentalParticipants will be randomized to receive one of 2 active dose levels of anvumetostat orally (PO) daily (QD) in 28 days cycles. Part 1 of the study will determine the recommended phase 2 dose (RP2D).
Receives: Drug: anvumetostat
Part 2: Dose ExpansionExperimentalParticipants will receive anvumetostat PO QD in 28-day cycles at the RP2D.
Receives: Drug: anvumetostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response (OR) per RECIST 1.1

    Measured: Up to 35 months

  2. Objective response (OR) Measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and Assessed per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)

    Measured: Up to 35 months

  3. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to 35 months

  4. Number of Participants Experiencing Events of Interest (EOIs)

    Measured: Up to 35 months

  5. Maximum Concentration (Cmax) of anvumetostat

    Measured: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose

  6. Time to Cmax (Tmax) of anvumetostat

    Measured: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose

  7. Area Under The Concentration-time Curve (AUC) of anvumetostat

    Measured: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose

Secondary outcomes (19)

  1. Disease Control (DC) by BICR

    Measured: Up to 35 months

  2. Duration of Response (DOR) by BICR

    Measured: Up to 35 months

  3. Time to Response (TTR) by BICR

    Measured: Up to 35 months

  4. Progression-free Survival (PFS) by BICR

    Measured: Up to 35 months

  5. OR by Investigator's Assessment

    Measured: Up to 35 months

  6. DC by Investigator's Assessment

    Measured: Up to 35 months

  7. DOR by Investigator's Assessment

    Measured: Up to 35 months

  8. TTR by Investigator's Assessment

    Measured: Up to 35 months

  9. PFS by Investigator's Assessment

    Measured: Up to 35 months

  10. Overall Survival (OS)

    Measured: Up to 35 months

  11. Number of Participants Experiencing TEAEs

    Measured: Up to 35 months

  12. Cmax of anvumetostat

    Measured: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose

  13. Tmax of anvumetostat

    Measured: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose

  14. AUC of anvumetostat

    Measured: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose

  15. Change in Quality of life (QoL) per The European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ)-C30

    Measured: Up to 12 months

  16. Change in QoL per Quality of Life Questionnaire-Lung Cancer 13 (QLQ LC13)

    Measured: Up to 12 months

  17. Change in QoL per European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)

    Measured: Up to 12 months

  18. Overall Health Status per Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Measured: Up to 12 months

  19. Overall Health Status per The Functional Assessment of Cancer Therapy - General (FACT-G)

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start26 Dec 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06593522
Sponsor's protocol ID
20230153
Status last verified
May 2026
First submitted
3 Sep 2024
Last updated
28 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anvumetostat in people with MTAP-deleted NSCLC, run by Amgen at 91 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, China, Brazil, Japan, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response (OR) per RECIST 1.1 (time frame: Up to 35 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06593522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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