LDK378 in crizotinib naive patients with advanced NSCLC
Research type
Research Study
Full title
A phase II, multicenter, single-arm study of oral LDK378 in crizotinib naïve adult patients with ALK-activated non-small cell lung cancer
IRAS ID
111655
Contact name
Rohit Lal
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2012-003474-36
ISRCTN Number
N/A
Research summary
The goal of this study is to find out if LDK378, a new investigational drug has any effect in patients with Non-small cell lung cancer (NSCLC) who have the abnormal ALK gene (i.e. ALK positive). We know from research that LDK378 can stop the growth of cancer cells by blocking the ALK protein which is responsible for sending growth signals to cancer cells. Available data from an ongoing phase I study indicate that LDK378 has antitumour activity in patients with ALK positive NSCLC. The aims of the trial are to:-See if LDK378 helps patients with ALK positive NSCLC who failed previous chemotherapy but are crizotinib naive-Find out more about LDK378 and what happens to it in the body-Learn more about the side effects This trial is sponsored by the pharmaceutical company named Novartis and is expected to last approximately 2 years. Patients will be asked to take LDK378 capsules once a day. About 105 patients will join this study from different countries. Patients will be carefully monitored during the study and will be asked to visit the study hospital every 2 weeks for the first month, then every 4 weeks. Because the safety and efficacy profile of LDK378 has not yet been established, access to this investigational compound is available only through carefully controlled and monitored clinical trials. Because of uncertainty of clinical trials, there is no guarantee that LDK378 will ever be commercially available anywhere in the world.
REC name
London - South East Research Ethics Committee
REC reference
12/LO/1818
Date of REC Opinion
14 Feb 2013
REC opinion
Further Information Favourable Opinion