ADAURA 2
Research type
Research Study
Full title
Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation positive Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumour Resection
IRAS ID
1004224
Contact name
Krishna Varsani
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-004135-89
Clinicaltrials.gov Identifier
Research summary
This study is being conducted to improve treatment for patients with non-small cell lung cancer that has been completely removed by surgery. This study is to determine how safe and effective osimertinib treatment is in preventing the cancer from coming back in patients after surgery. Osimertinib is a kinase inhibitor and is a proven treatment for larger cancers.
The study will include about 380 patients globally and will be conducted at hospitals with expertise in the treatment of lung cancer. Participants must be adult and have undergone complete surgical resection of their tumour. Tumour samples taken at surgery will be tested for an EGFR mutations (a gene mutation that can make cells grow too much and potentially cause cancer, which osimertinib works on). Only patients who had a tumour with a mutation in the EGFR gene will be included in this study.
Patients and their study doctors will not know what treatment they are receiving and will be randomly assigned to one of two groups:
- Osimertinib, 80mg tablet, taken orally every day.
- Placebo, matching tablet, taken orally every day.
Treatment will continue for 3 years. Patients will visit the clinic at week 12, week 24 and then every 24 weeks and at each visit, patients will undergo various procedures such as physical examination and laboratory tests to check the health status. Imaging with CT scans will be done during screening and during treatment. Patients will also be asked to complete quality of life questionnaires. Patients are free to withdraw from treatment at any time. The study doctor may decide that patients should stop the treatment due to toxicities. After the end of study treatment, patients remain in the study in order to follow up on disease outcomes. For patients without a recurrence of the cancer, this follow-up will include CT scans.
This study is anticipated to continue until 2032.REC name
North West - Haydock Research Ethics Committee
REC reference
21/NW/0343
Date of REC Opinion
20 Jan 2022
REC opinion
Further Information Favourable Opinion