Study Evaluating Zanidatamab Plus Standard Chemotherapy Versus Standard Chemotherapy Alone for Advanced HER2-positive Biliary Tract Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining Zanidatamab with the standard chemotherapy treatment Cisplatin and Gemcitabine CisGem, with or without a PD-1L1 inhibitor either Durvalumab or Pembrolizumab, for adults with advanced human epidermal growth factor receptor 2 HER2-positive biliary tract cancer. This phase 3 study focuses on participants with locally advanced or metastatic disease who have received limited prior therapy. Participants are randomly assigned to receive either Zanidatamab plus CisGem with or without a PD-1L1 inhibitor chosen by their physician, or CisGem with or without the PD-1L1 inhibitor alone. All drugs are administered intravenously. The study compares these two treatment approaches to assess their impact on disease progression and overall survival. Throughout the study, participants undergo regular assessments including tumor evaluations based on RECIST 1.1 criteria, physical functioning and symptom questionnaires, and monitoring for adverse events. The main outcome measured is progression-free survival in participants with HER2 IHC 3 tumors over up to 52 months, with additional outcomes including overall survival and treatment response tracked for up to 68 months. Safety and immune response are also monitored during this period.

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer