Study of Zolbetuximab Plus Chemotherapy vs. Placebo Plus Chemotherapy for Advanced Stomach or GEJ Cancer

Program Overview

This clinical trial is exploring whether Zolbetuximab, a drug that targets a protein called Claudin 18.2 found in many stomach and GEJ cancers, can improve treatment outcomes when combined with chemotherapy. Participants will either receive Zolbetuximab with chemotherapy or a placebo with chemotherapy. The study is being conducted in countries where Zolbetuximab is not yet approved. If it becomes approved during the study, participants in those countries will switch to the approved treatment. The main goal is to see if Zolbetuximab with chemotherapy is more effective than a placebo with chemotherapy in treating advanced stomach or GEJ cancer.

Description

In this study, participants will receive either Zolbetuximab with chemotherapy or a placebo with chemotherapy. The treatment is given in cycles, with Zolbetuximab or placebo and oxaliplatin administered through an infusion every three weeks, and capecitabine taken as tablets twice daily for the first two weeks of each cycle. Participants may continue receiving Zolbetuximab or placebo until their cancer worsens, they cannot tolerate the treatment, or they need another cancer treatment. Chemotherapy with CAPOX will be given for up to six months, after which participants may continue with capecitabine alone. Regular clinic visits will monitor participants' health and any side effects. Scans will be conducted to check for changes in the cancer. Participants may provide a tumor sample after treatment ends. Follow-up visits will occur within seven days after stopping treatment, and additional visits at one and three months after stopping treatment. Participants will have regular scans and health checks by phone every three months.

Eligibility Criteria

Locations