A global study to assess the effects of osimertinib following chemoradiation in patients with Stage III unresectable non-small cell lung cancer (LAURA) - LAURA

Study identifier:D5160C00048

ClinicalTrials.gov identifier:NCT03521154

EudraCT identifier:2018-001061-16

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III, randomized, double-blind, placebo-controlled, multicenter, international study of osimertinib as maintenance therapy in patients with locally advanced, unresectable EGFR mutation-positive Non-Small Cell Lung Cancer (Stage III) whose disease has not progressed following definitive platinum-based chemoradiation therapy (LAURA).

Medical condition

Non Small Cell Lung Cancer (Stage III)

Phase

Phase 3

Healthy volunteers

No

Study drug

Osimertinib 80mg/40mg, Placebo Osimertinib 80mg/40mg

Sex

All

Actual Enrollment

216

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 19 Jul 2018
Primary Completion Date: 05 Jan 2024
Estimated Study Completion Date: 29 Jun 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria