Ceritinib in ALK positive NSCLC patients with brain metastases
Research type
Research Study
Full title
A Phase II, multi-center, open-label, five-arm study to evaluate the efficacy and safety of oral ceritinib treatment for patients with ALK-positive non-small cell lung cancer (NSCLC) metastatic to the brain and/or to leptomeninges
IRAS ID
141696
Contact name
Tayeb Naveed
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Eudract number
2014-000578-20
Duration of Study in the UK
3 years, 1 months, 15 days
Research summary
In approximately 2- 8% of patients with advanced non-small cell lung cancer (NSCLC), there is a change to a gene called ALK (short for anaplastic lymphoma kinase). This change leads to an abnormal protein (ALK protein) that sends signals to cancer cells telling them to multiply and grow.
In these patients with ALK positive advanced NSCLC, the cancer could spread anywhere in their body (known as metastases). One of the most common sites is the brain (brain metastases), it is also the most difficult one to treat.The drug, Ceritinib (LDK378) is in a class of medications called ALK inhibitors. It works by blocking the action of the abnormal ALK protein. This helps to slow or stop the spread of cancer cells which ultimately stops or slows the growth and the spread of the tumour (known as anti tumoral activity).
This antitumoral activity of Ceritinib has been demonstrated in previous studies. Ceritinib has also showed activity in patients with brain metastases, known as intracranial response, suggesting that Ceritinib may be an effective therapy for patients with advanced NSCLC in whom the disease has spread in the brain (brain metastases).
The goal of this study is to further investigate the efficacy of Ceritinib in patients with advanced ALK + NSCLC with brain metastases including leptomeningeal disease. Leptomeninges are the membranes enveloping the brain and spinal cord.
Around 125 patients will be invited to take part in the study from many different countries including the UK. Only patients who have tested ALK positive and passed the screening assessments will be eligible for treatment. During the treatment period, patients will be asked to take Ceritinib once daily by mouth and return weekly for the first month and thereafter once a month for trial related medical assessments. Patients will continue to receive study treatment as long as the cancer is not growing and they can tolerate the drug.
This trial is sponsored by the pharmaceutical company named Novartis and because the safety and efficacy profile of Ceritinib has not yet been established in this group of patients, access to this investigational compound is available only through carefully controlled and monitored clinical trials such as this.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0312
Date of REC Opinion
29 Jul 2015
REC opinion
Further Information Favourable Opinion