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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 - Trial NCT06357533

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.

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NCT06357533
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06357533
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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
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)

Study Focus

Datopotamab Deruxtecan

Interventional

drug

Sponsor & Location

AstraZeneca

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 3

Apr 11, 2024

May 09, 2030

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 lung
Malignant neoplasm: Lower lobe, bronchus or lung
Malignant neoplasm: Middle lobe, bronchus or lung
Malignant neoplasm: Bronchus or lung, unspecified
Malignant neoplasm of bronchus and lung

Data Source

ClinicalTrials.gov

NCT06357533

Non-Device Trial