This phase 2 clinical trial will test the effectiveness of ceritinib (Zykadia) treatment, in treating ALK positive non-small cell lung cancer (NSCLC) with brain metastases and/or leptomeningeal carcinomatosis. The primary outcome will be measured by the disease response to treatment.
The details
Some lung cancers are associated with a mutation in the anaplastic lymphoma kinase (ALK) gene. This can lead to uncontrolled cancer cell growth. Ceritinib is a therapy that can inhibit (block) the ALK protein. This can prevent cancer cells from growing. It is not clear whether ceritinib is effective in patients with cancer spread (metastasis) to the brain or to the membranes surrounding the brain (leptomeningeal carcinomatosis).
This study will examine the response rate, time to disease progression, and overall survival in patients with ALK-mutated lung cancer with brain or leptomeningeal metastasis.
Who are they looking for?
This trial is recruiting 160 patients with ALK positive metastatic NSCLC that has spread to the brain or the membrane surrounding the brain in at least one location. Patients must also have a site of metastases outside the brain.
Patients should not have uncontrolled illnesses or gastrointestinal impairments. Ideal patients should not receive radiation therapy for brain metastases, increasing doses of corticosteroids, or have a history of another primary malignancy unless disease free for 3 years prior to the study.
How will it work
Participants will be divided into 5 groups. Group 1 will include patients with brain metastases who have been previously treated with radiation and an ALK inhibitor (crizotinib [Xalkori] only). Group 2 will include patients with brain metastases who have not been treated with radiation but have had prior exposure to an ALK inhibitor. Group 3 will include patients with brain metastases who have been previously treated with radiation but not an ALK inhibitor. Group 4 will include patients with brain metastases who have not been treated with either radiation or an ALK inhibitor. Group 5 will include patients with leptomeningeal carcinomatosis with or without brain metastases.
Patients will take a 750 mg dose of ceritinib once a day by mouth. Each dose will consist of 5 capsules. Patients will be treated for up to 24 weeks. Patients will undergo brain imaging with MRI every 8 weeks.
