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 - TROPION-Lung10

Study identifier:D7632C00001

ClinicalTrials.gov identifier:NCT06357533

EudraCT identifier:N/A

CTIS identifier:2023-505077-32-00

Recruiting

Official Title

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)

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Datopotamab Deruxtecan, Rilvegostomig, Pembrolizumab

Sex

All

Estimated Enrollment

675

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 11 Apr 2024
Estimated Primary Completion Date: 27 Apr 2028
Estimated Study Completion Date: 24 May 2030

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo

Inclusion and exclusion criteria