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NCT06357533Recruiting

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)
AstraZenecaPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Non-Small Cell Lung Cancer
Drug/Device/Intervention
Datopotamab Deruxtecan
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AstraZeneca
Location
Burbank,Grand Rapids,Hattiesburg,Greenville,Houston,Leesburg,Clayton,Melbourne,South Brisbane,Innsbruck,Krems,Linz,Rankweil,Wien,Wien,Anderlecht,Hasselt,La Louvière,Barretos,Curitiba,Florianópolis,Ipa, Australia,Austria,Belgium,Brazil,Canada,Germany,Hungary,India,Italy,Japan,Poland,South Korea,Spain,T
Timeline & enrollment
Phase
Phase 3
Start date
Apr 11, 2024
End date
May 09, 2030
Enrollment
675 participants
Primary outcome

Progression-Free Survival (PFS) in TROP2 biomarker positive participants.,Overall Survival (OS) in TROP2 biomarker positive participants.

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.

ICD-10 classifications
Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06357533
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06357533 through Pure Global AI's free database. This Phase 3 trial is sponsored by AstraZeneca and is currently Recruiting. The study focuses on Non-Small Cell Lung Cancer. Target enrollment is 675 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.