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Zolbetuximab and Other Cancer Treatments in People With Advanced Gastric or GEJ Cancer in Clinical Practice (RADIANCE)
Sponsor: Astellas Pharma Europe Ltd.
Summary
There is an unmet medical need to treat people with advanced cancer in the stomach, or where the food pipe joins the stomach. These conditions are known as advanced gastric cancer or advanced gastroesophageal cancer (GEJ for short). Zolbetuximab is an approved treatment for people with advanced stomach (gastric) cancer or advanced GEJ cancer. Some people with stomach or GEJ cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab works by attaching to the Claudin 18.2 protein in their tumor. This switches on the body's immune system to attack the tumor. The main aim of the study is to collect information about zolbetuximab and other cancer treatments in people with advanced gastric or GEJ cancer. This includes safety information, how long people respond to treatment and how long people live for without their cancer getting worse. This study is about collecting information only. This is known as an observational study. The individual's doctor decides on treatment, not the sponsor (Astellas). This study will use information from European and Canadian health registries and databases to learn more about people with advanced gastric or GEJ cancers who used zolbetuximab and other cancer treatments. The entire study will last about 4 years.
Official title: Real-world Clinical Outcomes, Patient Characteristics, and Treatment Patterns Among Patients With Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2-negative, Claudin-18 Isoform 2-positive Gastric or Gastroesophageal Junction Adenocarcinoma Treated With Zolbetuximab or Other First Line Treatments: A Cohort Study Using Secondary Data in Europe and Canada
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2026-10-31
Completion Date
2029-06-30
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Zolbetuximab Exposure
Real-world exposure to zolbetuximab.
Platinum-based Chemotherapy Exposure
Real-world exposure to platinum-based chemotherapy.
1L Treatment Not Containing Zolbetuximab Exposure
Real-world exposure to 1L treatment not containing zolbetuximab.
Fluoropyrimidine-based Chemotherapy Exposure
Real-world exposure to fluoropyrimidine-based chemotherapy.
Locations (1)
Research Institution
Alberta, Canada