Unresectable, Locally Advanced or Metastatic HER2 positive Gastric or Gastroesophageal Junction Cancer
Conditions
Brief summary
PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression or death due to any cause.
Detailed description
OS is defined as the time interval from the date of randomization to the date of death due to any cause., Incidence of TEAEs, SAEs, AESIs, deaths, ECOG performance status, vital signs, clinical laboratory results, ECGs, and ECHO/MUGA results., ORR is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR according to RECIST v1.1., PFS is defined as the time interval from the date of randomization to the date of disease progression or death due to any cause. Disease progression will be determined by investigators’ assessment of tumor scans according to RECIST v1.1., DoR is defined as the time from the date of first documentation of objective tumor response (CR or PR) for responding participants (CR or PR) only to the first documentation of objective tumor progression or death due to any cause., TTR is defined as the time from the date of randomization to the date of the first documentation of objective response (CR or PR). Time to response will be measured for responding participants (CR or PR) only., PFS2 is defined as the time from the date of randomization to the first documented progression on next-line therapy or death due to any cause., Serum concentrations of T-DXd, total anti-HER2-antibody, and DXd., The proportion of participants having treatment-emergent ADA. Titer and neutralizing antibodies will be determined when ADA is positive., Time to confirmed deterioration and change from baseline in the following measure: • FACT-GA subscale, Time to confirmed deterioration and change from baseline in the following measure: • FACT-GA Physical Well-being subscale, Time to confirmed deterioration and change from baseline in the following measure: • EQ-5D-5L VAS
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGDS-8201a
DRUG5-Fluorouracil Ebewe 50 mg/ml concentrat pentru soluţie injectabilă/perfuzabilă
DRUGCAPECITABINE
Sponsors
Daiichi Sankyo Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS is defined as the time interval from the date of randomization to the date of death due to any cause., Incidence of TEAEs, SAEs, AESIs, deaths, ECOG performance status, vital signs, clinical laboratory results, ECGs, and ECHO/MUGA results., ORR is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR according to RECIST v1.1., PFS is defined as the time interval from the date of randomization to the date of disease progression or death due to any cause. Disease progression will be determined by investigators’ assessment of tumor scans according to RECIST v1.1., DoR is defined as the time from the date of first documentation of objective tumor response (CR or PR) for responding participants (CR or PR) only to the first documentation of objective tumor progression or death due to any cause., TTR is defined as the time from the date of randomization to the date of the first documentation of objective response (CR or PR). Time to response will be measured | — |
Countries
Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain
Outcome results
None listed