Safety of alectinib in non-small cell lung cancer patients with RET fusion gene (ALL-RET): Results from the dose-finding portion of a phase 1/2 study

Authors:

Abstract
Background: The rearranged during transfection (RET) fusion gene was discovered as a driver oncogene in 1–2% of non-small cell lung cancer (NSCLC). Alectinib (300 mg BID) has been approved for the treatment of anaplastic lymphoma kinase (ALK) fusion-positive NSCLC in Japan; it also has a high activity against RET in vitro. A global trial showed the efficacy and safety of alectinib (600 mg BID) in ALK fusion-positive NSCLC patients. Therefore, we conducted a phase 1/2 study of alectinib to establish the recommended dose and examine its activity in RET fusion-positive NSCLC patients.