Oncology - Gastric or Gastroesophageal Junction Cancer Gastroesophageal Junction Cancer Stomach cancer
Conditions
Sponsors
Daiichi Sankyo, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Sign and date the Tissue Prescreening ICF, prior to HER2 and PD-L1 CPS central testing. • All participants must provide a tumor sample for tissue-based IHC staining to centrally determine HER2 expression and PD-L1 CPS status. • Enrollment in this clinical study is based on centrally determined HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or GEJ cancer as classified by ASCO-CAP for gastric cancer on a tumor biopsy as detected by prospective central test on new (core, incisional, excisional biopsy) or existing tumor tissue taken at the time of diagnosis of locally advanced or metastatic disease. • Centrally determined tumor PD-L1 CPS status using the PD-L1 IHC 22C3 PharmDx: - For the Main Cohort: PD-L1 CPS >=1 - For the Exploratory Cohort: PD-L1 CPS
Exclusion criteria
Exclusion criteria: • Prior exposure to other HER2-targeting therapies. • Cytology specimens or decalcified tissues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the trial is progression free survival as assessed by Blinded Independent Central Review, defined as the time interval from the date of randomization to the date of radiographic disease progression or death due to any cause. The objective of the primary efficacy analysis is to compare the progression free survival between the two arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary endpoint is overall survival, defined as the time interval from the date of randomization to the date of death due to any cause. The objective of the key secondary efficacy analysis is to compare the overall survival between the two arms. Calculate incidences of, for example, serious adverse events, treatment-emergent adverse events to assess safety and tolerability between arms within each cohort. For additional endpoints, refer to CSP (Attachment 5). | — |
Countries
Netherlands
Outcome results
None listed