Study identifier:D967SC00001
ClinicalTrials.gov identifier:NCT05048797
EudraCT identifier:2021-000634-33
CTIS identifier:N/A
An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Phase 3
No
Trastuzumab Deruxtecan, Cisplatin, Carboplatin, Pembrolizumab, Pemetrexed
All
450
Interventional
18 Years - 123 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
Daiichi Sankyo
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 Trastuzumab Deruxtecan (T-DXd) | Drug: Trastuzumab Deruxtecan Trastuzumab Deruxtecan administered by intravenous infusion Other Name: DS-8201a; T-DXd |
Active Comparator: Arm 2 Standard of Care Treatment (platinum, pemetrexed and pembrolizumab) | Drug: Cisplatin Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion Drug: Carboplatin Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion Drug: Pembrolizumab Pembrolizumab administered by intravenous infusion Drug: Pemetrexed Pemetrexed administered by intravenous infusion |