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

  • STATUS
    Not Recruiting
  • End date
    Jun 29, 2026
  • participants needed
    200
  • sponsor
    AstraZeneca
Updated on 23 May 2022
growth factor
epidermal growth factor receptor
EGFR
cancer chemotherapy
epidermal growth factor
osimertinib
lung carcinoma

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

Description

This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of osimertinib following chemoradiation in patients with stage III unresectable EGFR mutation-positive NSCLC, including the most common EGFR sensitising mutations (Ex19Del and L858R), either alone or in combination with other EGFR mutations. Chemoradiation may have been given either given concurrently or sequentially. Patients whose disease has not progressed following chemoradiation will be randomised within 6 weeks of completion of chemoradiation to receive osimertinib or placebo in a 2:1 ratio, and treatment will be continued until disease progression, unacceptable toxicity or other discontinuation criteria are met. After progression, patients can be unblinded and may receive open-label osimertinib. After the final OS analysis, the study blind will be broken and patients still receiving open-label osimertinib will be supplied with open-label osimertinib by AstraZeneca for as long as their treating physician considers they are deriving clinical benefit.

Details
Condition Non Small Cell Lung Cancer (Stage III)
Treatment Osimertinib 80mg/40mg, Placebo Osimertinib 80mg/40mg
Clinical Study IdentifierNCT03521154
SponsorAstraZeneca
Last Modified on23 May 2022

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