MTAP-deleted NSCLC
Conditions
Keywords
Oncology, anvumetostat
Brief 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).
Interventions
DRUGanvumetostat
Film-coated tablet
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response (OR) per RECIST 1.1 | Up to 35 months |
| 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) | Up to 35 months |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to 35 months |
| Number of Participants Experiencing Events of Interest (EOIs) | Up to 35 months |
| Maximum Concentration (Cmax) of anvumetostat | 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 |
| Time to Cmax (Tmax) of anvumetostat | 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 |
| Area Under The Concentration-time Curve (AUC) of anvumetostat | 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
| Measure | Time frame |
|---|---|
| Disease Control (DC) by BICR | Up to 35 months |
| Duration of Response (DOR) by BICR | Up to 35 months |
| Time to Response (TTR) by BICR | Up to 35 months |
| Progression-free Survival (PFS) by BICR | Up to 35 months |
| OR by Investigator's Assessment | Up to 35 months |
| DC by Investigator's Assessment | Up to 35 months |
| DOR by Investigator's Assessment | Up to 35 months |
| TTR by Investigator's Assessment | Up to 35 months |
| PFS by Investigator's Assessment | Up to 35 months |
| Overall Survival (OS) | Up to 35 months |
| Number of Participants Experiencing TEAEs | Up to 35 months |
| Cmax of anvumetostat | 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 |
| Tmax of anvumetostat | 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 |
| AUC of anvumetostat | 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 |
| Change in Quality of life (QoL) per The European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ)-C30 | Up to 12 months |
| Change in QoL per Quality of Life Questionnaire-Lung Cancer 13 (QLQ LC13) | Up to 12 months |
| Change in QoL per European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) | Up to 12 months |
| Overall Health Status per Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Up to 12 months |
| Overall Health Status per The Functional Assessment of Cancer Therapy - General (FACT-G) | Up to 12 months |
Countries
Australia, Brazil, Canada, China, Czechia, Hong Kong, Japan, Latvia, Netherlands, Portugal, Singapore, South Korea, Switzerland, Taiwan, Turkey (Türkiye), United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed