The purpose of this study is to evaluate the safety and effectiveness of this investigational
drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small
cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got
worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act
on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA or ALECENSA).
A significant population of Anaplastic Lymphoma Kinase (ALK) plus Non-small cell lung cancer
patients exist that have progressed on or who were intolerant of second generation anaplastic
lymphoma kinase inhibitor (e.g. ceritinib or alectinib). Brigatinib has demonstrated activity
in patients who have progressed on crizotinib, but the activity of brigatinib in patients who
have progressed on ceritinib, alectinib, or other second generation anaplastic lymphoma
kinase inhibitors is unknown. Based on the preclinical data. 3, , brigatinib has activity
against known secondary anaplastic lymphoma kinase mutations suggesting it may retain
activity after second-generation anaplastic lymphoma kinase inhibitors.
Patients enrolled in ARI-AT-002 must have previously received a second generation Anaplastic
lymphoma kinase inhibitor other than brigatinib. We have chosen 20% as a clinically
meaningful response rate that would justify further study of brigatinib in previously treated
anaplastic lymphoma kinase plus disease.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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