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)

Amgen

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).

Eligibility

Age range: 18–99 years
Sex: All
Healthy volunteers: No

Detailed 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 r…

Interventions

Drug
anvumetostat
Film-coated tablet

Locations (91)

City of Hope National Medical Center
Duarte, California
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, California
Cedars-Sinai Medical Center
Los Angeles, California
Valkyrie Clinical Trials
Los Angeles, California
University of California Los Angeles
Los Angeles, California
Rocky Mountain Cancer Centers
Denver, Colorado