A Phase III Study of Erlotinib Given After Surgery for Early-Stage EGFR-Positive Non-Small Cell Lung Cancer

Full Title

Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC) (Alliance A081105) (CIRB)

Purpose

Erlotinib is a drug approved for the treatment of advanced non-small cell lung cancers (NSCLC) that are caused by an abnormal form of the EGFR protein. In this study, researchers want to assess the effectiveness of erlotinib for treating earlier stages of EGFR-mutated NSCLC that has been surgically removed.

Patients in this study will be randomly assigned to receive either erlotinib or a placebo (inactive pill) after lung cancer surgery and completion of any recommended standard therapy. Erlotinib is taken orally (by mouth) for up to two years.

Eligibility

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

  • Patients must have stage IB, II, or IIIA EGFR-mutated NSCLC that has been surgically removed.
  • At least 4 weeks must pass since major surgery and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jamie Chaft at 646-888-4545.

Protocol

15-276

Phase

III

Investigator

Co-Investigators