Study name: AMG 193 in Combination With Carboplatin, Pemetrexed and Pembrolizumab; With Carboplatin, Paclitaxel and Pembrolizumab; or With Pembrolizumab in Subjects With Advanced NSCLC With Homozygous MTAP-deletion
Histology
NSCLC, all subtypes
Tumor stage
Stage III - IV
Host / recruiting site 1
Radboud UMC
Enrollment
Recruiting
Therapy line
First line (1L)
Design
Fase 1 dose exploration and dose expansion
Intervention
PRTM5 and MTA inhibitor in combination with standard first-line immuno(-chemo)therapy
Key inclusion criteria
Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before AMG 193 dosing.
Homozygous MTAP-deletion.
Able to swallow and retain PO administered study treatment.
Disease measurable as defined by RECIST v1.1.
Key exclusion criteria
Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
History of solid organ transplant.
Major surgery within 28 days of first dose of AMG 193.
Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
Radiation therapy within 28 days of first dose.
Autoimmune disease or immunodeficiency disease as defined in the protocol.
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