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 (RADIANCE)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001120
• Study ID:
  1000001120
• Official title and acronym:
  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 (RADIANCE)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  Germany

  Portugal

  Spain

  Sweden
• Study description:
  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. ;
• Study status:
  Ongoing

Research institutions and networks

Institutions

Astellas Pharma Europe Ltd.

Study timelines

Date when funding contract was signed

Actual:11/12/2024

Study start date

Actual:13/06/2025

Data analysis start date

Planned:31/05/2027

Date of interim report, if expected

Planned:31/08/2028

Date of final study report

Planned:31/03/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe Ltd.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

8951-MA-3584