ClinicalTrials.gov marked primary completion on 2024-01-05 for NCT03521154, the phase 3 LAURA study of osimertinib after chemoradiation in unresectable stage III non-small cell lung cancer. The trial enrolled 216 participants and compared osimertinib with placebo.

Background

The study focused on stage III unresectable non-small cell lung cancer with EGFR mutation positive disease, a population described in the record as receiving osimertinib following chemoradiation. Osimertinib is also known as Tagrisso.

Trial design

LAURA was a phase 3 global study in 216 participants with Non Small Cell Lung Cancer (Stage III). The intervention arms were listed as osimertinib 80mg/40mg and placebo osimertinib 80mg/40mg. The posted record highlights progression-free survival assessed by blinded independent central review as the key outcome measure.

Key results

For Progression-free Survival (PFS) by Blinded Independent Central Review (BICR), median PFS was 39.13 months with osimertinib versus 5.55 months with placebo.

In analysis data, the log-rank test showed a hazard ratio of 0.16 with a 95% confidence interval 0.1 to 0.24 and p=0.001. Additional subgroup analyses reported a Cox proportional hazard model hazard ratio of 0.17 for PFS in Ex19Del positive patients, 0.32 for PFS in L858R positive patients, and 0.22 for Negative at screening. Other posted log-rank analyses showed hazard ratios of 0.17 with 95% confidence interval 0.09 to 0.32 and p=0.001, and 0.81 with 95% confidence interval 0.42 to 1.56 and p=0.53.

For event counts in patients with EGFR Ex19del or L858R mutation, the record listed 26 PFS events with osimertinib and 39 with placebo in one entry, 31 and 24 in another, and 0 and 0 in a third. In patients with EGFR mutations Ex19del or L858R detectable in plasma-derived ctDNA, the record listed 4 and 4 in one entry and 42 and 51 in another.

What this means

The posted data indicate a strong progression-free survival benefit for osimertinib after chemoradiation in this stage III unresectable EGFR-mutated NSCLC trial. Because the record comes from a primary completion posting rather than a full journal article, clinicians and analysts should rely on the posted ClinicalTrials.gov figures when citing the trial and await any additional reporting for broader context.

Source

This information is based on ClinicalTrials.gov for NCT03521154, posted on 2024-01-05. The record is available at clinicaltrials.gov.