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Clinical Trials in the UK / NCT06357533
Recruiting Phase 3

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 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-04-11
Last updated
2026-08-12

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Datopotamab DeruxtecanRilvegostomigPembrolizumab

Datopotamab Deruxtecan: Datopotamab Deruxtecan IV (intravenous)

Rilvegostomig: Rilvegostomig IV (intravenous)

Pembrolizumab: Pembrolizumab IV (intravenous)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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 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 Exclusion Criteria: * Prior systemic therapy for advanced/metastatic NSCLC. * Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant. * History of another primary malignancy within 3 years * Active or prior documented autoimmune or inflammatory disorders (with exceptions) * Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocol. * Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage. * History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Has significant pulmonary function compromise, as determined by the investigator * Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants. * History of leptomeningeal carcinomatosis * Known clinically significant corneal disease * Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled * History of active primary immunodeficiency

Primary outcome measure(s)

Trial sites (287)

FacilityCityRegionStatus
Research Site Anchorage Alaska Recruiting
Research Site Tucson Arizona Recruiting
Research Site Little Rock Arkansas Recruiting
Research Site Springdale Arkansas Recruiting
Research Site Anaheim California Recruiting
Research Site Beverly Hills California Recruiting
Research Site Fountain Valley California Recruiting
Research Site Newport Beach California Suspended
Research Site Clermont Florida Recruiting
Research Site Gainesville Florida Recruiting
Research Site Miami Beach Florida Recruiting
Research Site Orange City Florida Recruiting
Research Site Orlando Florida Recruiting
Research Site Orlando Florida Withdrawn
Research Site West Palm Beach Florida Recruiting
Research Site Atlanta Georgia Suspended
Research Site Atlanta Georgia Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Atlanta Georgia Withdrawn
Research Site Hinsdale Illinois Recruiting
Research Site Noblesville Indiana Recruiting
Research Site Paducah Kentucky Recruiting
Research Site Annapolis Maryland Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Dearborn Michigan Recruiting
Research Site Farmington Hills Michigan Recruiting
Research Site Grand Rapids Michigan Recruiting
Research Site Traverse City Michigan Withdrawn
Research Site Hattiesburg Mississippi Recruiting
Research Site Kansas City Missouri Recruiting
Research Site Bozeman Montana Withdrawn
Research Site Grand Island Nebraska Recruiting
Research Site Omaha Nebraska Recruiting
Research Site Las Vegas Nevada Recruiting
Research Site Reno Nevada Withdrawn
Research Site Voorhees Township New Jersey Suspended
Research Site Stony Brook New York Recruiting
Research Site Greenville North Carolina Recruiting
Research Site Salisbury North Carolina Recruiting

+ 247 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06357533 on ClinicalTrials.gov ↗ ← All trials in the UK