Trials / Recruiting
RecruitingNCT06357533
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 675 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This is a Phase III, randomized, open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig monotherapy compared with 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Datopotamab Deruxtecan | Datopotamab Deruxtecan IV (intravenous) |
| DRUG | Rilvegostomig | Rilvegostomig IV (intravenous) |
| DRUG | Pembrolizumab | Pembrolizumab IV (intravenous) |
Timeline
- Start date
- 2024-04-11
- Primary completion
- 2029-12-28
- Completion
- 2029-12-28
- First posted
- 2024-04-10
- Last updated
- 2026-03-16
Locations
281 sites across 21 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Germany, Hungary, India, Italy, Japan, Poland, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06357533. Inclusion in this directory is not an endorsement.