*ALKALINE (EORTC 1825-LCG)
Research type
Research Study
Full title
Activity of Lorlatinib based on ALK resistance mutations on blood in ALK positive NSCLC patients previously treated with 2nd generation ALK inhibitor
IRAS ID
285461
Contact name
Fiona Blackhall
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer
Eudract number
2019-003862-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 1 days
Research summary
This study is for adults who have ALK positive advanced Non Small Cell Lung Cancer (NSCLC). These patients have received treatment but their tumour has grown again. This may be due to genetic mutations making the tumour resistant to the treatment. This study will evaluate the activity of a drug called lorlatinib based on the presence of these mutations in patients' blood. These ‘liquid biopsies’ will be collected to assess the impact of ALK resistant mutations on patient outcomes to lorlatinib treatment, and so identify which patients may benefit most.
There is also a sub-study for adults with the same cancer type who are receiving treatment. This will assess the time between identifying a genetic mutation that is making the tumour resistant to treatment and the tumour growing again. At the point the tumour grows, this group of patients may be offered the opportunity to take part in the main study.
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 the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0192
Date of REC Opinion
18 Jan 2021
REC opinion
Favourable Opinion