Evaluating AMG 193 for advanced lung cancer with MTAP deletion
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)
This study is testing two different doses of a new drug called AMG 193 to see if it can help people with advanced lung cancer that has a specific genetic change and who have already tried other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Amgen Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 91 sites (Duarte, California and 90 other locations) |
| Trial ID | NCT06593522 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of two different doses of AMG 193 in patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic deletion (MTAP). Participants must have previously received treatment and experienced disease progression. The efficacy of AMG 193 will be evaluated through a blinded independent review to ensure unbiased results. The study focuses on patients with a confirmed diagnosis of MTAP-deleted NSCLC who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are individuals with metastatic or unresectable locally advanced NSCLC that has a homozygous deletion of the MTAP gene and have progressed after at least one prior systemic therapy.
Not a fit: Patients with tumors that have mutations suitable for targeted therapies other than MTAP deletion may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with a specific genetic profile of advanced lung cancer.
How similar studies have performed: While there have been studies targeting specific genetic mutations in lung cancer, the approach of using AMG 193 specifically for MTAP-deleted NSCLC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Duarte, California and 90 other locations
- City of Hope National Medical Center — Duarte, California, United States (Recruiting)
- City of Hope Orange County Lennar Foundation Cancer Center — Duarte, California, United States (Recruiting)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Valkyrie Clinical Trials — Los Angeles, California, United States (Recruiting)
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
- Rocky Mountain Cancer Centers — Denver, Colorado, United States (Recruiting)
- Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States (Recruiting)
- Hartford HealthCare Cancer Institute - Manchester — Plainville, Connecticut, United States (Recruiting)
- Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States (Recruiting)
- Our Lady of the Lake Cancer Institute — Baton Rouge, Louisiana, United States (Recruiting)
- Trinity Health Saint Joseph Mercy Ann Arbor — Ann Arbor, Michigan, United States (Recruiting)
- Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States (Recruiting)
- Sarah Cannon Research Institute Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- United States Oncology Regulatory Affairs Corporate Office — Nashville, Tennessee, United States (Recruiting)
- Texas Oncology Central/South Texas — Austin, Texas, United States (Recruiting)
- Sarah Cannon Research Institute — Dallas, Texas, United States (Recruiting)
- Texas Oncology - Dallas Fort Worth — Dallas, Texas, United States (Recruiting)
- US Oncology Research Investigational Products Center — Irving, Texas, United States (Recruiting)
- Texas Oncology Northeast Texas — Tyler, Texas, United States (Recruiting)
- Virginia Cancer Specialists PC — Fairfax, Virginia, United States (Recruiting)
- GenesisCare -North Shore Oncology — St Leonards, New South Wales, Australia (Recruiting)
- Calvary Mater Newcastle Hospital — Waratah, New South Wales, Australia (Recruiting)
- Mater Hospital Brisbane — South Brisbane, Queensland, Australia (Recruiting)
- Cancer Research South Australia — Adelaide, South Australia, Australia (Recruiting)
- Núcleo de Oncologia da Bahia — Salvador, Estado de Bahia, Brazil (Recruiting)
- Liga Norte-Riograndense Contra O Cancer — Natal, Rio Grande do Norte, Brazil (Recruiting)
- Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
- Hospital Nossa Senhora da Conceicao — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
- Fundacao pio xII Barretos — Barretos, São Paulo, Brazil (Recruiting)
- Fund Faculdade Regional Med Sao Jose Rio Preto — São José do Rio Preto, São Paulo, Brazil (Recruiting)
- Instituto do Cancer Estado SP Icesp — São Paulo, São Paulo, Brazil (Recruiting)
- Fundacao Antonio Prudente - Hosp AC Camargo — São Paulo, São Paulo, Brazil (Recruiting)
- Instituto de Educacao Pesquisa e Gestao em Saude — Rio de Janeiro, Brazil (Recruiting)
- Centro Paulista de Oncologia — São Paulo, Brazil (Recruiting)
- Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)
- William Osler Health System - Brampton Civic Hospital — Brampton, Ontario, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Centre Glen Site — Montreal, Quebec, Canada (Recruiting)
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
- Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
- Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
- The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
- Jilin Cancer Hospital — Changchun, Jilin, China (Recruiting)
- Jinan Central Hospital — Jinan, Shandong, China (Recruiting)
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- West China Hospital Sichuan University — Chengdu, Sichuan, China (Recruiting)
- The First Affiliated Hospital Zhejiang University School Of Medicine — Hangzhou, Zhejiang, China (Recruiting)
+41 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.