A Phase I Study of EGF816 in Patients with Lung Cancer Containing the EGFR T790M Mutation

Full Title

A Phase I/II, Multicenter, Open-Label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients with EGFRmut Solid Malignancies


Most non-small cell lung cancers (NSCLC) treated with the standard therapy erlotinib (a drug used to treat cancers with a mutated form of the epidermal growth factor receptor, or EGFR) eventually grow despite this treatment. In many patients, the resistance to EGFR inhibitors like erlotinib is due to a mutation called EGFR T790M.

In this study, researchers are evaluating the safety and effectiveness of an investigational drug called EGF816 in patients with NSCLC that contain the EGFR T790M mutation. EGF816 binds to mutated EGFR and prevents it from working. Doctors hope it will be effective in patients whose NSCLC has stopped responding to erlotinib or other EGFR inhibitors.

EGF816 is a pill that is taken orally (by mouth).


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

  • Patients must have NSCLC that contains the EGFR T790M mutation.
  • Patients may not have received more than three regimens of anticancer therapy for advanced cancer.
  • A sufficient amount of time must have passed since completion of prior therapy and entry into the study, ranging from 2 to 4 weeks depending on the treatment, and patients must have recovered from any serious side effects of therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Gregory Riely at 646-888-4199.