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

Protocol
12-278
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
Phase
I
Purpose

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.

Eligibility

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.

Disease(s)
Lung Cancer, Non-Small Cell
Locations