drugset / Trial / NCT06357533

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

NCT06357533

Phase 3 Recruiting 675 enrolled AstraZeneca Daiichi Sankyo · collab
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2024-04-11
Primary completion
2029-12-28
Completion
2029-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Datopotamab deruxtecan Monoclonal antibody 6 mg/kg Intravenous
Comparator Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Rilvegostomig Other / unclassified 750 mg Intravenous