Phase II Study Comparing Usual Treatment With or Without Zanidatamab for HER2 Positive Advanced Gastroesophageal Adenocarcinoma

What this Trial Is About

Researchers are evaluating whether adding a drug called zanidatamab to the usual treatment combination of paclitaxel and ramucirumab can reduce the chance of gastroesophageal adenocarcinoma growing or spreading. This study focuses on adults with HER2 positive advanced gastroesophageal adenocarcinoma who have not responded to prior trastuzumab-containing therapy. The goal is to find out if adding zanidatamab improves outcomes compared to standard treatment alone. Participants will be randomly assigned to receive either the usual treatment of paclitaxel and ramucirumab or this combination plus zanidatamab. The doses of paclitaxel and ramucirumab are specified, while zanidatamab dosing will be assigned at enrollment. This Phase II study compares these approaches to see if the addition of zanidatamab can reduce the risk of cancer progression by at least 37%. Throughout the study, participants will undergo scans and imaging to track disease status, quality of life questionnaires, and monitoring of side effects. Blood and tumor tissue samples will be collected for marker studies. The primary outcome measure is progression-free survival over 36 months, with secondary measures including overall survival, response rate, adverse events, and quality of life assessments. Treatment and follow-up will continue as outlined until study completion or other endpoints.

Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma