AZD9291 v chemotherapy in NSCLC, following EGFR TKI therapy (AURA3)
Research type
Research Study
Full title
A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene
IRAS ID
156834
Contact name
Fiona Blackhall
Contact email
Eudract number
2014-000594-39
Clinicaltrials.gov Identifier
Research summary
AZD9291 is an experimental treatment for patients with non-small cell lung cancer (NSCLC) whose lung cancer is due to the development of specific changes in the gene that produces a protein on the surface of the cell called the Epidermal Growth Factor Receptor (EGFR). When the gene changes it is said to have developed a mutation. Patients who have NSCLC with a mutation in EGFR can be treated with specific drugs called EGFR tyrosine kinase inhibitors (EGFR TKIs). Unfortunately, after a period of therapy with EGFR TKIs, a significant number of tumours will develop resistance to this treatment due to a second EGFR mutation called T790M (an acquired mutation associated with EGFR-TKI resistance). It is hoped that AZD9291 is effective against some tumours that have begun to grow despite EGFR TKI therapy.
This study is being carried out to see if AZD9291 is effective as a targeted therapy for treating patients with NSCLC with the EGFR and T790M mutations, and if so, how AZD9291 compares with chemotherapy.
No approved therapies currently exist to specifically target patients with NSCLC with the EGFR and T790M mutations. This is a phase III, open-label, randomised study to assess the safety and efficacy of AZD9291 versus standard of care platinum-based doublet chemotherapy in patients with EGFR mutation positive and T790M mutation positive, locally advanced or metastatic NSCLC who have progressed following treatment with an approved EGFR TKI agent.
Two-thirds of patients will receive AZD9291 (80mg, orally, once daily). One-third of patients will receive platinum-based doublet chemotherapy (pemetrexed + carboplatin or pemetrexed + cisplatin) on day 1 of every 21-day cycle. For patients randomised to the chemotherapy arm, the choice of chemotherapy will be decided by the Study Doctor on a patient-by-patient basis.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
14/EE/1063
Date of REC Opinion
14 Aug 2014
REC opinion
Further Information Favourable Opinion