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)
AstraZeneca
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically documented non-squamous NSCLC. * Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation. * Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies. * Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers. * Known tumour PD-L1…
Interventions
- DrugDatopotamab Deruxtecan
Datopotamab Deruxtecan IV (intravenous)
- DrugRilvegostomig
Rilvegostomig IV (intravenous)
- DrugPembrolizumab
Pembrolizumab IV (intravenous)
Locations (281)
- Research SiteAnchorage, Alaska
- Research SiteTucson, Arizona
- Research SiteLittle Rock, Arkansas
- Research SiteSpringdale, Arkansas
- Research SiteAnaheim, California
- Research SiteBeverly Hills, California