ZANGEA – Phase II Study of Zanidatamab in Combination with Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients

Condition studied

Gastroesophageal Adenocarcinoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Progression-free survival rate at 12 months (PFS@12), estimated using Kaplan Meier method and defined as proportion of patients alive and progression-free 12 months after start of trial medication

Endpoint detail

Overall response rate (ORR), defined as proportion of patients achieving complete or partial response (CR/PR) acc. to RECIST v1.1., Disease control rate (DCR), defined as proportion of patients achieving CR, PR, or stable disease (SD) acc. to RECIST v1.1., Duration of response (DoR), defined as time from response initiation (when either CR or PR is first determined) to disease progression acc. to RECIST v1.1 or death due to any cause., Progression-free survival (PFS), defined as time from first treatment until date of progression acc. to RECIST v1.1 or death due to any cause., Overall survival (OS), defined as time from first treatment until date of death due to any cause., Assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing, and severity of adverse events using NCI CTCAE v5.0, Assessment of QoL during treatment and follow-up using EORTC QLQ- C30 and EQ-5D-5L questionnaires.