Clinical Trial

A Multicenter, Randomized, Open-label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-line Treatment in Participants with Unresectable, Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction (GEJ) Cancer

MOA: Trastuzumab deruxtecan (TDXd) is a HER2- directed ADC

Key Eligibility Criteria:

• Previously untreated, unresectable, locally advanced or metastatic HER2-positive gastric or GEJ cancer
• Centrally determined tumor PD-L1 CPS
  • Main Cohort: PD-L1 CPS ≥1
  • Exploratory Cohort: PD-L1 CPS <1
• Must provide a tumor sample for tissue-based IHC staining
• At least 1 target measurable lesion on CT or MRI
• Subjects with prior exposure to HER2-targeted therapy are excluded
• Subjects with known DPD enzyme deficiency are excluded