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
Lung Cancer
Unknown Primary
18 Years and older, Male and Female
D7632C00001 (primary)
NCI-2024-07729
2023-505077-32-00
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.
Objectives
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.
Eligibility
- 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 expression status defined as TC = 50%
- At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline
- ECOG performance status of 0 or 1
- Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention
Treatment Sites in Georgia
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