A Phase II Study of Neratinib Alone and with Temsirolimus in Patients with Non-Small Cell Lung Cancer with HER2 Mutations

Full Title
A Phase 2 Study of Neratinib and Neratinib Plus Temsirolimus in Patients with Non-Small Cell Lung Cancer Carrying Known HER2 Activating Mutations

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.


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of stage IIIB or IV non-small cell lung cancer that is positive for the HER2 mutation.
  • There are no restrictions on the number of prior regimens of therapy.
  • Patients may not have previously received neratinib, everolimus, or temsirolimus.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Mark Kris at 646-888-4197.

Lung Cancer, Non-Small Cell