A Phase I Study of Daily Low-Dose Erlotinib and Twice Weekly High-Dose Erlotinib in Patients with EGFR-Mutant Non-Small Cell Lung Cancer

Full Title

A Phase 1 Trial of Low Dose Daily Erlotinib in Combination with High Dose Twice Weekly Erlotinib in Patients with EGFR-Mutant Lung Cancer


Erlotinib is a drug used to treat advanced lung cancers that contain a mutation in the EGFR gene. It is typically given at a dose of 150 mg a day, taken orally (by mouth). However, after about a year of treatment, most patients experience continued growth of their cancer.

The purpose of this study is to evaluate a new dosing schedule for erlotinib in patients with advanced non-small cell lung cancer (NSCLC) who have EGFR mutations. Computer modeling and laboratory studies suggest this new dosing schedule may be effective against the cancer for a longer period of time than the current dosing schedule. Patients will take a high dose of erlotinib on two days of the week and a low dose on each of the other five days of the week.


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

  • Patients must have inoperable stage III or stage IV NSCLC.
  • Patients may not have received prior treatment with tyrosine kinase inhibitors (the drug class to which erlotinib belongs).
  • Patients should have recovered from the serious side effects of prior therapies before entering the study.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Helena Yu at 646-888-4274.