Tracking the Effectiveness of New Treatments for Stomach Cancer

Recruiting · Phase 3 · Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer and related conditions · 23 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This study looks at how well zolbetuximab works with pembrolizumab and chemotherapy for adults with stomach or gastroesophageal junction cancer. These cancers won't have a protein called HER2 but will have a protein called Claudin 18.2. The main goal is to see how long people live after this treatment compared to a placebo that looks like zolbetuximab but has no medicine in it.

The trial's ID number is NCT06901531. It is a Phase 3 study, which means it is looking at how well the treatment works and how safe it is. The trial is regulated by the FDA and aims to include about 500 participants.

Who can join

Adults aged 18 and older with advanced stomach or gastroesophageal junction cancer can join. They should have tumors that are HER2-negative and Claudin 18.2-positive. Some previous treatments are okay, but people with certain serious gut issues cannot participate. The trial team will confirm if potential participants meet all the requirements.

Conditions

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be randomly placed into one of two groups. One group will receive zolbetuximab, pembrolizumab, and chemotherapy. The other group will receive a placebo, pembrolizumab, and chemotherapy. Everyone will get treatments through intravenous infusions, and the chemotherapy will include either CAPOX or mFOLFOX6 regimens.