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Real-world outcomes of zolbetuximab and other treatments in advanced stomach or junction cancer

Reviews health records of adults with advanced stomach cancer treated with zolbetuximab or other drugs.

Key facts

Who runs it
Astellas Pharma Europe Ltd.
Where
Alberta, CanadaSee the site
Trial code
Registry title
Zolbetuximab and Other Cancer Treatments in People With Advanced Gastric or GEJ Cancer in Clinical Practice (RADIANCE)
Status
Not yet recruiting
People taking part
1,000 people, planned
Starts
31 Jan 2027
Expected to end
30 Jun 2029
Type of study
Observational, 3 groups
Treatments tested
  • Zolbetuximab Exposure
  • Platinum-based Chemotherapy Exposure
  • 1L Treatment Not Containing Zolbetuximab Exposure
  • Fluoropyrimidine-based Chemotherapy Exposure
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

This study uses existing health records. It looks at adults with advanced stomach or gastroesophageal junction cancer who started first treatment, with or without zolbetuximab.

Age
18 years or older at the start of first treatment.
Sex
All sexes.
Disease stage
Stomach or gastroesophageal junction adenocarcinoma. For two groups, stage 3 or stage 4 disease that cannot be removed by surgery.
Earlier treatment
Starting first-line treatment during the enrolment period. One group gets zolbetuximab with platinum-fluoropyrimidine chemotherapy. One group gets other first treatments. One group got zolbetuximab outside its approved use.
Biomarker or test result
For two groups, HER2-negative tumor and CLDN18.2-positive tumor (75% or more of tumor cells with moderate or strong staining).

Main reasons for not taking part

  • Another primary cancer in the 5 years before the start date, except non-melanoma skin cancer
  • Received the treatment as part of a clinical trial

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Cohorts A, B and C:
  • Incident diagnosis of G/GEJ adenocarcinoma, as identified according to ICD-10 diagnosis codes (C16.x, C15.2, C15.5, C15.8, C15.9) and ICD for Oncology Third Edition (ICD-O-3) morphology codes (8140-8149, 8160-8162, 8190-8221, 8260-8337, 8350 8551, 8570-8576, 8940-8941) or data source equivalent
  • At least 18 years of age at the date of 1L treatment initiation; Cohorts A and B:
  • Evidence of unresectable stage 3 or stage 4 disease
  • Evidence of HER2(-) tumor any time prior to and including the date of 1L treatment initiation
  • Evidence of CLDN18.2-positive tumor, defined as ≥75% of tumor cells showing moderate (2+) or strong (3+) membranous staining by IHC, assessed prior to or on the date of 1L treatment initiation; Cohort A only:
  • 1L treatment with zolbetuximab in combination with platinum-fluoropyrimidine doublet chemotherapy which begins during the patient enrolment period; Cohort B only:
  • 1L treatment that does not include zolbetuximab which begins during the patient enrolment period; Cohort C only:
  • Zolbetuximab administered during the patient enrolment period under any of the following off-label conditions:; NOT delivered in 1L for la/m disease and/or; NOT delivered in combination with platinum-fluoropyrimidine doublet, and/or; Delivered in combination with any systemic anti-cancer treatment that is not platinum-fluoropyrimidine doublet, and/or; NOT delivered to a patient with evidence of HER2(-) tumor any time prior to and including the date of zolbetuximab initiation, and/or; NOT delivered to a patient with evidence of CLDN18.2(+)-positive tumor, defined as ≥75% of tumor cells demonstrating moderate (2+) or strong (3+) membranous staining by IHC, assessed prior to or on the date of zolbetuximab initiation

Who cannot take part

  • Evidence of any other primary malignancy in the 5 years prior to and including the index date, as identified according to ICD-10 codes or data source equivalent and excluding non-melanoma skin cancer (ICD-10 code C44.x); Cohort A only:
  • Evidence that 1L treatment with zolbetuximab was received as part of a clinical trial; Cohort B only:
  • Evidence that 1L treatment was received as part of a clinical trial; Cohort C only:
  • Evidence that zolbetuximab was received as part of a clinical trial
  • Cohorts A, B and C:

Where in Canada

  • Research InstitutionAlberta, CanadaContact: Astellas Pharma Europe Ltd.No longer taking part

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Cohort A: zolbetuximab with platinum-fluoropyrimidine chemotherapy

    Participants with human epidermal growth factor receptor 2-negative (HER2\[-\]) and claudin-18 isoform 2-positive (CLDN18.2\[+\]) locally advanced unresectable or metastatic (la/m) gastric or gastroesophageal junction (G/GEJ) adenocarcinoma who received first-line (1L) treatment with zolbetuximab in combination with platinum-fluoropyrimidine doublet chemotherapy.

    Treatment: Zolbetuximab Exposure, Platinum-based Chemotherapy Exposure, and Fluoropyrimidine-based Chemotherapy Exposure

  • Cohort B: 1L treatment which did not contain zolbetuximab

    Participants with HER2(-) and CLDN18.2(+) la/m G/GEJ adenocarcinoma who received 1L treatment which did not contain zolbetuximab.

    Treatment: 1L Treatment Not Containing Zolbetuximab Exposure

  • Cohort C: off-label treatment with zolbetuximab

    Participants with G/GEJ adenocarcinoma who received off-label treatment with zolbetuximab.

    Treatment: Zolbetuximab Exposure

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Real-world outcomes of zolbetuximab and other treatments in advanced stomach or junction cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 October 2026