HER2 is a protein that can fuel cancer growth when mutated. Neratinib is an investigational drug designed to inhibit cancer growth by targeting cancer cells with a mutated form of the HER2 gene. Prior studies have shown that the effectiveness of neratinib may be enhanced by combining it with another anticancer drug called temsirolimus. Temsirolimus is approved for the treatment of advanced kidney cancer, but its use in lung cancer is considered investigational. It works on another protein called mTOR that HER2 stimulates.
The purpose of this study is to evaluate the safety and effectiveness of neratinib alone as well as in combination with temsirolimus in patients with stage IIIB and IV non-small cell lung cancers that have mutated HER2. Patients will be randomly assigned to receive neratinib alone or neratinib plus temsirolimus.
Neratinib is taken orally (by mouth) each day. For those assigned to receive temsirolimus, it is given intravenously (by vein) once a week.