Erlotinib Hydrochloride in Preventing Cancer in Patients With Precancerous Lesions of the Lung

Inclusion Criteria:

• Diagnosis of a premalignant lung lesion (metaplasia or dysplasia) on autofluorescent bronchoscopy (AFB) within 1 month
• Participants must have a >= 10 pack year lifetime smoking history; current and former smokers only are eligible for this trial
• No contraindications for treatment with erlotinib or additional bronchoscopies
• Absolute neutrophil count (ANC) of >= 1.5 x 10^9/L
• Platelet count of >= 100 x 10^9/L
• Creatinine level of less than 1.5 mg/dL
• Total bilirubin =< 2.0 mg/dl
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN)
• Alkaline phosphatase =< 2.5 x ULN
• Must meet Eastern Cooperative Oncology Group (ECOG) performance status criteria of 0-1
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) throughout the duration of the study and for 1 month following cessation of study drug; females must begin adequate contraception immediately following screening pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately; if she is pregnant, she will be immediately withdrawn from the study
• Ability to understand and the willingness to sign a written institutional review board (IRB) approved informed consent document

Exclusion Criteria:

• Subjects with life-threatening medical conditions that would preclude the treatment intervention and bronchoscopy, including, but not limited to, unstable pulmonary function, acute cardiac failure, which is unstable despite medication use; uncontrolled hypertension; uncontrolled diabetes mellitus; unstable coronary artery disease; acute or chronic liver disease, ongoing or active infection; or psychiatric illness/social situations that would limit compliance with study requirements
• Participants with evidence of an active cancer or carcinoma in situ, are not eligible
• Participants currently taking medications that induce or inhibit the cytochrome P450, family 3, subfamily A, polypeptide 4-7 (CYP3A4-7) enzymes
• Participants may not be receiving any other investigational agents within 3 months
• Participants taking warfarin
• History of allergic reactions attributed to erlotinib, a known hypersensitivity to erlotinib, or agents with a similar chemical or biological composition to erlotinib
• Women who are pregnant or lactating are excluded from the study because based on the proposed mechanism of tyrosine kinase inhibition of erlotinib; erlotinib should be assumed to cause fetal harm when administered to a pregnant woman; there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erlotinib
• History of interstitial lung disease (ILD)