Osimertinib with or without chemotherapy in EGFR positive NSCLC
Research type
Research Study
Full title
A phase III, open-label, randomized study of osimertinib with or without platinum plus pemetrexed chemotherapy, as first-line treatment in patients with epidermal growth factor receptor (EGFR) mutation-positive, locally advanced or metastatic non-small cell lung cancer (FLAURA-2)
IRAS ID
278270
Contact name
Huiqi Yang
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2019-000650-61
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 15 days
Research summary
The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR).
Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient’s cancer.
In total the study aims to enroll approximately 586 patients, consisting of approximately 30 patients who will participate in a safety run-in component of the trial, and approximately 556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the main trial. In the main part of the trial there is a one in two chance of receiving osimertinib alone, and the treatment is decided at random by a computer. The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study centre.REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0189
Date of REC Opinion
10 Jul 2020
REC opinion
Further Information Favourable Opinion