Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07858500

Zolbetuximab and Other Cancer Treatments in People With Advanced Gastric or GEJ Cancer in Clinical Practice (RADIANCE)

Sponsor: Astellas Pharma Europe Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

Zolbetuximab Exposure

Real-world exposure to zolbetuximab.

DRUG

Platinum-based Chemotherapy Exposure

Real-world exposure to platinum-based chemotherapy.

DRUG

1L Treatment Not Containing Zolbetuximab Exposure

Real-world exposure to 1L treatment not containing zolbetuximab.

DRUG

Fluoropyrimidine-based Chemotherapy Exposure

Real-world exposure to fluoropyrimidine-based chemotherapy.

Locations (1)

Research Institution

Alberta, Canada