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A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)
This is a is a randomised trial with three arms. In the Arm A (Active Comparator), participants will receive Trastuzumab (administered intravenously [IV]) plus the physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP). In Arm B (Experimental), participants will receive Zanidatamab (administered via IV) plus physician's choice of CAPOX or FP. In Arm C (Experimental), participants will receive Zanidatamab and tislelizumab (administered via IV) plus physician's choice of CAPOX or FP. For all groups, Capecitabine will be administered orally (PO bid), while oxaliplatin, cisplatin and 5-fluorouracil will be administered via IV. Participants will be tested for HER2 gene-amplification using the ISH-based companion diagnostic assay, and also tested for HER2 protein-expression using the IHC-based companion diagnostic assay.