BENITIONSClinical Trial Intelligence

A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)

Phase 3 Active, not recruiting NCT03521154

ConditionNon Small Cell Lung Cancer
PhasePhase 3
SponsorAstraZeneca
StatusActive, not recruiting
Enrollment216 participants
InterventionsOsimertinib 80mg/40mg, Placebo Osimertinib 80mg/40mg
Start dateJul 19, 2018
Completion dateJan 5, 2024
Results postedApr 3, 2025

Summary

A global study to assess the efficacy and safety of osimertinib following chemoradiation in patients with stage III unresectable Epidermal Growth Factor Receptor Mutation Positive non-small cell lung cancer

Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)

Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months · Months

Osimertinib39.13 Months
Placebo5.55 Months
p-value<0.001
Hazard Ratio (HR)0.16 (95% CI 0.10–0.24)

Open in BENITIONS View on ClinicalTrials.gov

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