Study identifier:D7632C00001
ClinicalTrials.gov identifier:NCT06357533
EudraCT identifier:N/A
CTIS identifier:2023-505077-32-00
A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)
Non-small Cell Lung Cancer
Phase 3
No
Datopotamab Deruxtecan, Rilvegostomig, Pembrolizumab
All
675
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2024 by AstraZeneca
AstraZeneca
Daiichi Sankyo
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1: Dato-DXd in Combination With Rilvegostomig Participants in the Dato-DXd in combination with Rilvegostomig group will receive Dato-DXd plus rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. | Drug: Datopotamab Deruxtecan Datopotamab Deruxtecan IV (intravenous) Other Name: Dato-DXd Drug: Rilvegostomig Rilvegostomig IV (intravenous) Other Name: AZD2936 |
Experimental: Arm 2: Rilvegostomig Monotherapy Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. | Drug: Rilvegostomig Rilvegostomig IV (intravenous) Other Name: AZD2936 |
Active Comparator: Arm 3: Pembrolizumab Monotherapy Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. | Drug: Pembrolizumab Pembrolizumab IV (intravenous) Other Name: KEYTRUDA |