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 Jul 2025 by AstraZeneca
AstraZeneca
Daiichi Sankyo
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
This is a Phase III, randomized, 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.
Location
Status
Location
Newmarket, ON, Canada, L3Y 2P9
Status
Withdrawn
Location
Gauting, Germany, 82131
Status
Recruiting
Location
Seoul, Republic of Korea, 03080
Status
Recruiting
Location
Seoul, Republic of Korea, 03722
Status
Recruiting
Location
Suwon, Republic of Korea, 16247
Status
Recruiting
Location
New Taipei, Taiwan, Province of China, 220
Status
Recruiting
Location
Taoyuan, Taiwan, Province of China, 333
Status
Recruiting
Location
Taichung, Taiwan, Province of China, 40447
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig Participants in the Datopotamab Deruxtecan (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 |
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