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

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.

Trial Details

NCT ID

NCT06357533

Phase

PHASE3

Sponsor

AstraZeneca

Status

RECRUITING

Cancer Type

Non-Small Cell (NSCLC) Lung Cancer

Interventions

Datopotamab Deruxtecan
Rilvegostomig
Pembrolizumab

Locations (sample)

Anchorage, Alaska, United States|61.21806,-149.90028
Tucson, Arizona, United States|32.22174,-110.92648
Little Rock, Arkansas, United States|34.74648,-92.28959
Springdale, Arkansas, United States|36.18674,-94.12881
Anaheim, California, United States|33.83529,-117.9145

Key Eligibility 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 …
Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alt…
Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.

For full eligibility, visit ClinicalTrials.gov.

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