Clinical Trial: Cancer, Lung Cancer

Lung Cancer A081105: A 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

Full Name

A 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)

Description

If you meet all eligibility requirements and choose to take part in this research study, you will be randomly assigned to one of two groups. Group 1 will get the study drug called erlotinib. Erlotinib will be taken once a day. Group 2 will get the placebo, which looks like erlotinib, but does not contain any active ingredient. The placebo will be taken once a day. Treatment in both groups will last for up to 2 years as long as you do not have too many side effects, and the tumor has not grown back. While you are receiving treatment, you will see your study doctor for a check-up and certain tests every 3 weeks for the first 12 weeks after you start treatment, and then at least every 6 weeks while you continue on treatment. You will then see your study doctor every 6 months for the first 4 years after starting treatment, and then yearly for the following 6 years, for a total of 10 years. You will also have a CT scan during these visits. This is a double-blind study, which means that neither you nor your study doctor will know to which treatment you were assigned.

Eligibility

Inclusion Criteria
Must be greater than or equal to 18 years of age Must have been previously registered to A15126, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation Must have completely resected Stage IB, II or IIIA non-squamous non-small cell lung cancer with negative margins Must have an ECOG Performance Status of 0-1 Must have no history of cornea abnormalities
Doctor(s) Running This Study