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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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)

NCT06357533•AstraZeneca

View on ClinicalTrials.gov

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.

Detailed 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

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (281)

Research Site

Anchorage, Alaska, United States

Research Site

Tucson, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Springdale, Arkansas, United States

Research Site

Anaheim, California, United States

Research Site

Beverly Hills, California, United States

Research Site

Fountain Valley, California, United States

Research Site

Newport Beach, California, United States

Research Site

Clermont, Florida, United States

Research Site

Gainesville, Florida, United States

Key Dates

Start Date

April 11, 2024

Primary Completion Date

December 28, 2029

Completion Date

December 28, 2029

Last Updated

March 16, 2026

Enrollment

675

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer

Interventions

Datopotamab Deruxtecan

DRUG

Rilvegostomig

DRUG

Pembrolizumab

DRUG

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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