Clinical Trials in Canada / NCT07858500
Starting soon
Observational
Zolbetuximab and Other Cancer Treatments in People With Advanced Gastric or GEJ Cancer in Clinical Practice (RADIANCE)
NCT07858500 · tracked via the Priya Life Science Canada tracker
Condition(s) studied
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerLocally Advanced Unresectable Gastric Adenocarcinoma or CancerMetastatic Gastric Adenocarcinoma or CancerMetastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
Investigational drug(s) / intervention(s)
Zolbetuximab Exposure →Platinum-based Chemotherapy Exposure1L Treatment Not Containing Zolbetuximab ExposureFluoropyrimidine-based Chemotherapy Exposure
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.
Study 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.
Eligibility
Inclusion Criteria:
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.
Exclusion Criteria:
Cohorts A, B and C:
* 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.
Primary outcome measure(s)
- Cohort A: real-world overall survival (rwOS) — From the point of initiating 1L treatment, assessed up to 4 years
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. - Cohort A: real-world progression-free survival (rwPFS) — From the point of initiating 1L treatment, assessed up to 4 years
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. - Cohort A: real-world time to next treatment (rwTTNT) — From the point of initiating 1L treatment, assessed up to 4 years
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. - Cohort A: real-world time to next treatment or death (rwTTNTD) — From the point of initiating 1L treatment, assessed up to 4 years
The length of time a participant survives without initiating 2L treatment, from the point of initiating 1L treatment, using data retrieved retrospectively. - Cohort A: real-world time to progression (rwTTP) — From the point of initiating 1L treatment, assessed up to 4 years
The length of time until a participant's cancer progresses, from the point of initiating 1L treatment, using data retrieved retrospectively. Progression will be identified according to clinical notes, radiology reports or pathology reports. Death due to any cause will be considered a competing event. - Cohort A: real-world duration of response (rwDOR) — From the point of initiating 1L treatment, assessed up to 4 years
The length of time a participant responds to 1L treatment without dying or their cancer progressing, from the first record of complete or partial response to 1L treatment, using data retrieved retrospectively. Response will be identified as per clinical assessment, and progression will be identified according to clinical notes, radiology reports or pathology reports. Death due to any cause will be considered in the definition of rwDOR. - Cohort A: real-world response rate (rwRR) — From the point of initiating 1L treatment, assessed up to 12 months
The percentage of participants who have responded to 1L treatment within 12 months following initiation of 1L treatment, using data retrieved retrospectively. Complete or partial response will be identified as per clinical assessment. - Cohort A: real-world disease control rate (rwDCR) — From the point of initiating 1L treatment, assessed up to 12 months
The percentage of participants who have either responded to 1L treatment or have achieved stable disease within 12 months following initiation of 1L treatment, using data retrieved retrospectively. Complete response, partial response and stable disease will be identified as per clinical assessment. - Cohort A: real-world tumor growth rate (rwTGR) prior to 1L treatment — Day 1
The percentage change in tumor size over the period of time between the second to last and last tumor size record prior to index date. rwTGR will be assessed prior to initiating 1L treatment based on medical history available, using data retrieved retrospectively. Tumor size will be estimated as the sum of the longest diameters of all recorded measurable lesions (primary or metastatic). - Cohort A: rwTGR — From point of initiating 1L treatment, assessed up to 4 years
The percentage change in tumor size from prior to initiation of 1L treatment, over a period of time. rwTGR will be assessed during 1L treatment using data retrieved retrospectively. Tumor size will be estimated as the sum of the longest diameters of all recorded measurable lesions (primary or metastatic). - Cohort A: number of records of specified adverse events (AEs) — From the point of initiating 1L treatment, assessed up to 4 years
Specified AEs are inclusive of nausea, vomiting, decreased appetite, diarrhea, peripheral sensory neuropathy, anemia, constipation, decreased neutrophil count, fatigue, asthenia, abdominal pain, stomatitis, weight decrease, aspartate aminotransferase increase, platelet count decrease, hypoalbuminemia, white blood cell count decrease and neutropenia. An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. - Cohort A: duration of specified AEs — From the point of initiating 1L treatment, assessed up to 4 years
The total length of time a participant has a record of experiencing a specified AE occurrence during 1L treatment, using data retrieved retrospectively. - Cohort A: time to first specified AE record — From the point of initiating 1L treatment, assessed up to 4 years
The length of time until a participant experiences each of the specified AEs above during 1L treatment, from the point of initiating 1L treatment, using data retrieved retrospectively. - Cohort A: number of participants with serious adverse events (SAEs) — From the point of initiating 1L treatment, assessed up to 4 years
SAEs are any signs, symptoms, or diseases which lead to inpatient hospitalization, treatment discontinuation and/or cause death and which are experienced during 1L treatment. Events will be identified from participant records retrieved retrospectively; there is no requirement for the events to be explicitly linked to 1L treatment. - Cohort A: number of SAEs experienced per participant — From the point of initiating 1L treatment, assessed up to 4 years
SAEs are any signs, symptoms, or diseases which lead to inpatient hospitalization, treatment discontinuation and/or cause death and which are experienced during 1L treatment. Events will be identified from participant records retrieved retrospectively. - Cohort A: number of specific SAE — From the point of initiating 1L treatment, assessed up to 4 years
SAEs are any signs, symptoms, or diseases which lead to inpatient hospitalization, treatment discontinuation and/or cause death and which are experienced during 1L treatment. Events will be identified from participant records retrieved retrospectively. - Cohort A: number of records per participant of specific SAE — From the point of initiating 1L treatment, assessed up to 4 years
SAEs are any signs, symptoms, or diseases which lead to inpatient hospitalization, treatment discontinuation and/or cause death and which are experienced during 1L treatment. Events will be identified from participant records retrieved retrospectively. - Cohort A: time to first SAE record — From the point of initiating 1L treatment, assessed up to 4 years
The length of time until a participant experiences a SAE during 1L treatment, from the point of initiating 1L treatment, using data retrieved retrospectively. - Cohort A: number of participants with inpatient hospitalizations — From the point of initiating 1L treatment, assessed up to 4 years
Number of inpatient hospitalizations during 1L treatment, as recorded up to end of 1L treatment (inclusive), using data retrieved retrospectively. - Cohort A: number of inpatient hospitalizations with ICU stay per participant — From the point of initiating 1L treatment, assessed up to 4 years
Number of inpatients hospitalizations per participant with ICU stay during 1L treatment, as recorded from index date (inclusive) to end of 1L treatment (inclusive), using data retrieved retrospectively. - Cohort A: number of inpatient hospitalizations with admission via accident and emergency (A&E) per participant — From the point of initiating 1L treatment, assessed up to 4 years
Number of inpatients hospitalizations per participant with admission via A\&E during 1L treatment, as recorded from index date (inclusive) to end of 1L treatment (inclusive), using data retrieved retrospectively. - Cohort A: duration of inpatient hospitalizations — From the point of initiating 1L treatment, assessed up to 4 years
Average duration (in days) of inpatient hospitalization during 1L treatment, as derived according to the difference between admission and discharge dates for all inpatient hospitalizations from index date (inclusive) to end of 1L treatment (inclusive), using data retrieved retrospectively. One participant may experience more than one hospitalization and may contribute multiple times for this variable. - Cohort A: primary diagnoses associated with inpatient hospitalizations — From the point of initiating 1L treatment, assessed up to 4 years
Primary diagnoses associated with inpatient hospitalizations during 1L treatment, as recorded using diagnosis codes (International Classification of Diseases, 10th revision \[ICD-10\] codes, or equivalent as available in each data source), using data retrieved retrospectively. A participant can have multiple diagnoses per inpatient hospitalization and multiple inpatient hospitalization. - Cohort A: number of participants receiving at least one antiemetic — From the point of initiating 1L treatment, assessed up to 4 years
Number of participants with prescriptions or dispensations of any antiemetic drug from 1 day before index date (inclusive) to the end of 1L treatment (inclusive), using data retrieved retrospectively. - Cohort A: number of antiemetics prescribed or dispensed to participants — From the point of initiating 1L treatment, assessed up to 4 years
Number of records of prescriptions or dispensations of any antiemetic drug from 1 day before index date (inclusive) to the end of 1L treatment (inclusive), using data retrieved retrospectively. - Cohort A: time to prescription or dispensation of any antiemetic drugs — From the point of initiating 1L treatment, assessed up to 4 years
Time from index date to first prescription or dispensation of antiemetic drugs during 1L treatment, using data retrieved retrospectively. - Cohort A: type of antiemetic drug received immediately prior to 1L treatment — Day 1
Type of antiemetic drug prescribed immediately prior to 1L treatment, as recorded 1 day before index date (inclusive) based on medical history available, using data retrieved retrospectively. - Cohort A: type of antiemetic drug received — From the point of initiating 1L treatment, assessed up to 4 years
Type of antiemetic drug prescribed during 1L treatment, as recorded to the end of 1L treatment (inclusive), using data retrieved retrospectively. - Cohort A: antiemetic drugs received immediately prior to 1L treatment — Day 1
Antiemetic drugs prescribed immediately prior to 1L treatment, as recorded 1 day before index date (inclusive) based on medical history available, using data retrieved retrospectively. - Cohort A: antiemetic drugs received — From the point of initiating 1L treatment, assessed up to 4 years
Antiemetic drugs prescribed during 1L treatment, as recorded to the end of 1L treatment (inclusive), using data retrieved retrospectively.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Institution | Alberta | Canada |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07858500 on ClinicalTrials.gov ↗ ← All trials in Canada