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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  VYLOY
• Study drug International non-proprietary name (INN) or common name:
  ZOLBETUXIMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX31) zolbetuximab

  zolbetuximab
• Medical condition to be studied:
  Gastric cancer

Population studied

• Short description of the study population:
  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). Some people with stomach or GEJ cancer have a protein called Claudin 18.2 in their tumor.
• Age groups:
  • Adults (18 to < 65 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)
  • Elderly (≥ 65 years)

    • Adults (65 to < 75 years)
    • Adults (75 to < 85 years)
    • Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Study design:
  This is a descriptive cohort study of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma in Europe and Canada. This study will use secondary data sources and employ a waved design for retrospective data collection and analysis.
• Main study objective:
  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.
• Outcomes:
  1. Overall survival (OS); 2. Real-world progression free survival (rwPFS); 3. Time to next treatment (TTNT); 4. Time to next treatment or death (TTNTD); 5. Real-world time to progression (rwTTP); 6. Real-world duration of response (rwDOR); 7. Real-world response rate (rwRR); 8. Real-world disease control rate (rwDCR); 9. Real-world tumor growth rate (rwTGR); 10. AEs; 11. Duration of AEs; 12. Time to first AE; 13. Serious AEs (SAEs); 14. Duration of SAEs; 15. Time to first SAE; 16. Inpatient hospitalizations; 17. Management of nausea/vomiting;
• Data analysis plan:
  Time-to-event variables will be analyzed using Kaplan-Meier method if death is one of the events of interest. Otherwise, death will be considered a competing event, and a non-parametric estimator of the cumulative incidence function will be used. All time-to-event endpoints will be depicted graphically using cumulative incidence functions to enable an easier comparison, with the number of patients still at risk at discrete time points tabulated below the curves. Median survival time will be reported for each outcome, along with the IQR and 2-sided 95% CIs. The probability of experiencing the event(s) of interest by each time point will be estimated and reported along with the corresponding 2-sided 95% CIs. ; ; Descriptive statistics will be used to report all other variables, as applicable. Continuous variables will be described by the mean, standard deviation (SD), median, IQR and minimum and maximum values (where possible). Categorical variables will be described by the number and percentage of patients in each category. The number of patients with missing data for each variable will be reported; no imputation for missing data will be performed. ; ; Data will be pooled across all data sources that are able to share individual patient data. Additionally, to obtain pooled estimates of all clinical outcomes across all countries and data sources, meta-analysis will be performed for Cohorts A and B. Country-specific estimates for each clinical outcome will be aggregated using a random effects model with inverse variance weighting using the DerSimonian and Laird approach. Cohorts are expected to be comparable due to the consistent study design across countries; however, statistical heterogeneity will be assessed using the I^2-statistic, with values >50% interpreted as indicative of substantial heterogeneity.; ; Analyses will be descriptive in nature, with no statistical tests or formal comparisons between cohorts performed unless otherwise noted.