EORTC-1613-LCG (APPLE)
Research type
Research Study
Full title
APPLE trial: Feasibility and activity of AZD9291 (osimertinib) treatment on Positive PLasma T790M in EGFR mutant NSCLC patients.
IRAS ID
233866
Contact name
Raffaele Califano
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Eudract number
2016-001834-82
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
This study is for adults who have advanced non-small-cell lung cancer (NSCLC) with a specific change (mutation) to one of the genes called EGFR. People with this mutation are currently treated with certain drugs to block them (such as gefitinib, erlotinib or afatinib). However it has been found that some people have a very specific mutation (called EGFR T790M) causing resistance to the treatment. This means that the tumour starts to grow again. The purpose of the study is to find out the best of way of treating this group of people by comparing three different treatment options. Each option uses drugs (either osimertinib or gefitinib or both) designed to target this mutation but they will be received in a different order. To find out which option is best, the length of time that participants live with the disease before it gets worse (disease progression) is measured at 18 months after they have joined the study.
The study will compare the treatment options using clinical examinations, regular scans and blood tests. Tumour samples and blood tests will also be used to understand the effects of the drugs.
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by a non-profit organisation called the EORTC (European Organisation for Research and Treatment of Cancer), based in Brussels.REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0430
Date of REC Opinion
18 Jun 2018
REC opinion
Favourable Opinion