A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC
MTAP-deleted NSCLCThe main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR).
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer
* 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), KRAS proto-oncogene (KRAS).
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.
Study Location
McGill University Health Centre Glen Site
McGill University Health Centre Glen SiteMontreal, Quebec
Canada
Contact Study Team
- Study Sponsored By
- Amgen
- Participants Required
- More Information
- Study ID:
NCT06593522