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Studieoverzicht

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)
PD-L1 expression Negative: <1% ,  Low: 1 - 49% ,  High: ≥50%
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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