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

ConditionsLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerLocally Advanced Unresectable Gastric Adenocarcinoma or CancerMetastatic Gastric Adenocarcinoma or CancerMetastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstellas Pharma Europe Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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).

Evidence that 1L treatment with zolbetuximab was received as part of a clinical trial.

Evidence that 1L treatment was received as part of a clinical trial.

Evidence that zolbetuximab was received as part of a clinical trial.

Trial population

Four registries or databases and at least 9 electronic medical record (EMR)-enabled sites will be used as data sources for this study. The study population will include participants with la/m HER2(-) and CLDN18.2(+) G/GEJ adenocarcinoma treated in 1L with zolbetuximab in combination with platinum-fluoropyrimidine doublet chemotherapy. A wider population of participants with la/m HER2(-) and CLDN18.2(+) G/GEJ adenocarcinoma, including those treated with other 1L treatments, will also be explored, as well as participants treated off-label with zolbetuximab.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Zolbetuximab Exposure

    Drug

    Real-world exposure to zolbetuximab.

  • Platinum-based Chemotherapy Exposure

    Drug

    Real-world exposure to platinum-based chemotherapy.

  • 1L Treatment Not Containing Zolbetuximab Exposure

    Drug

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

  • Fluoropyrimidine-based Chemotherapy Exposure

    Drug

    Real-world exposure to fluoropyrimidine-based chemotherapy.

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Cohort A: zolbetuximab with platinum-fluoropyrimidine chemotherapy3 interventions
Group B: Cohort B: 1L treatment which did not contain zolbetuximab1 intervention
Group C: Cohort C: off-label treatment with zolbetuximab1 intervention

Trial outcomes

Primary outcomes

1

Cohort A: real-world overall survival (rwOS)

The length of time a participant survives, from the point of initiating 1L treatment, using data retrieved retrospectively. Death due to any case will be considered in the definition of rwOS.

Time frame
From the point of initiating 1L treatment, assessed up to 4 years
2

Cohort A: real-world progression-free survival (rwPFS)

The length of time a participant survives without their cancer progressing, from the point of initiating 1L treatment, using data retrieved retrospectively. Progression will be identified according to clinical notes, radiology reports or pathology reports, and death due to any cause will be considered in the definition of rwPFS.

Time frame
From the point of initiating 1L treatment, assessed up to 4 years
3

Cohort A: real-world time to next treatment (rwTTNT)

The length of time until a participant initiates second-line (2L) treatment, from the point of initiating 1L treatment, using data retrieved retrospectively. Death due to any cause will be considered a competing event.

Time frame
From the point of initiating 1L treatment, assessed up to 4 years
4

Cohort A: real-world time to next treatment or death (rwTTNTD)

The length of time a participant survives without initiating 2L treatment, from the point of initiating 1L treatment, using data retrieved retrospectively.

Time frame
From the point of initiating 1L treatment, assessed up to 4 years

Secondary outcomes

1

Cohort A demographic characteristics: age

Age as recorded or derived based on participant birth date, date of diagnosis, and 1L treatment initiation, using data retrieved retrospectively.

Time frame
Day 1
2

Cohort A demographic characteristics: sex

Sex as recorded at any time in participant records (female, male, or missing/unknown), using data retrieved retrospectively.

Time frame
Day 1
3

Cohort A demographic characteristics: race or ethnicity

Ethnicity or race (Asian, black, mixed, or multiple ethnic groups, white, other ethnic group, or missing/unknown), as recorded at any time in participant records, using data retrieved retrospectively.

Time frame
Day 1
4

Cohort A demographic characteristics: country

Country of treatment site, as derived according to the country in which the data source is located, using data retrieved retrospectively.

Time frame
Day 1

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Research Institution Status unavailable AlbertaCanadaCanada

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Astellas Pharma Europe Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: