Neoadjuvant Osimertinib and Chemotherapy in Resectable NSCLC
Research type
Research Study
Full title
A Phase III, Randomised, Controlled, Multi-centre, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination with Chemotherapy versus Standard of Care Chemotherapy Alone for the Treatment of Patients with Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer (NeoADAURA)
IRAS ID
281969
Contact name
Carles Escriu
Contact email
Sponsor organisation
AstraZeneca UK Ltd
Eudract number
2020-000058-89
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 8 months, 22 days
Research summary
The reason for this study is to research the effectiveness of osimertinib (TAGRISSO®) when given either alone or in combination with chemotherapy prior to surgery in patients with early stage, non -small cell lung cancer when compared to chemotherapy alone. The main reason to test this treatment before surgery is to give the study drug an early chance to kill undetectable cancer cells in the body and delay time to recurrence or reduce the chance of the disease returning. Some lung cancers have detectable mutations in the DNA that can help physicians decide the best treatment for their patients. One such mutation is called the Epidermal Growth Factor Receptor (EGFR), which is targeted by the study drug osimertinib.
In total the study aims to enroll approximately 351 patients. Patients will have a one in three chance of receiving either osimertinib with chemotherapy, osimertinib alone or chemotherapy alone in the main treatment part of the trial prior to surgery. The treatment is decided at random by a computer. The patients assigned to either the osimertinib and chemotherapy group or chemotherapy alone, will not know which therapy they are receiving. Those patients assigned to the osimertinib treatment group will know which therapy they are receiving.
The study involves a Screening Period, Treatment Period, Surgery and Post-Surgery Period. It is expected patients will attend, on average, approximately 3 visits over the first 3 months, followed by surgery. The post-surgery period will last up to 5 years and during this period patients will receive whatever treatment the treating physicians decide is best for the patient (including, potentially, osimertinib). Each visit will last about 1 to 6 hours depending on the arrangement of medical assessments by the study center.
REC name
East of England - Essex Research Ethics Committee
REC reference
20/EE/0255
Date of REC Opinion
21 Dec 2020
REC opinion
Further Information Favourable Opinion