A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination
with Pembrolizumab Versus Platinum-based Chemotherapy in Combination with Pembrolizumab,
as First-line Therapy in Participants with Locally Advanced Unresectable or Metastatic
HER2-overexpressing and PD-L1 TPS
Phase 3 – large-scale trial before approval
Conditions:
Unresectable or Metastatic HER2 overexpressing and PD-L1 TPS
Sponsor: Daiichi Sankyo Inc.
trial.available_in:
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Overview
Trial status: Authorised
Overall Survival (OS). OS is defined as the time interval from the date of randomization to the date of death due to any cause.
Progression-free survival (PFS) by BICR. 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. Tumor response will be determined by BICR assessment of tumor scans using RECIST v1.1.
Description
Overall Survival (OS). OS is defined as the time interval from the date of randomization to the date of death due to any cause.
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 159 participants
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