Intervention: Erlotinib
Trial phase: Phase 2
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.

Erlotinib Hydrochloride: Given PO

Therapeutic Conventional Surgery: Undergo thoracotomy

Laboratory Biomarker Analysis: Correlative studies
Eligibility criteria:
Inclusion Criteria:

Pathologically proven (either histologic or cytologic) diagnosis of stage IIIA or IIIB non-small cell lung cancer; (according to American Joint Committee on Cancer [AJCC] staging, 7th edition) within 4 weeks of registration; the patient should have histologically or cytologically confirmed N2 disease
Activating mutation in EGFR
No prior chemotherapy or radiation for lung cancer
Patients may be potentially resectable or unresectable

Stage III A or B disease, including no distant metastases- based on following diagnostic workup:

History/physical examination prior to registration
Computed tomography (CT) scan of the chest or positron emission tomography (PET) scan within 28 days of study entry
CT scan of abdomen or magnetic resonance imaging (MRI) of abdomen or PET scan within 28 days of study entry
An MRI of the brain or head CT scan with contrast within 28 days of study entry
Total body PET scan within 28 days of study entry
Mediastinoscopies are highly recommended
Patients must have measurable or evaluable disease
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Absolute neutrophil count (ANC) >= 1,500 cells/ul
Platelets >= 100,000 cells/ul
Hemoglobin >= 9.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= g/dl is acceptable)
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x the ULN

Women of childbearing potential must have:

A negative serum or urine pregnancy test (sensitivity =< 25 IU human chorionic gonadotropin [HCG]/L) within 72 hours prior to the start of study drug administration
Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Ability to take oral medication
Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

Pleural or pericardial effusion

Pleural effusions allowed if one of the following conditions are met: 1) negative cytology after adequate sampling by thoracentesis 2) effusion seen on CT scan but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance

Severe, active co-morbidity, defined as follows:

Cardiac symptoms; any of the following should be considered for exclusion:

Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within (6 months)
Diagnosed congenital long QT syndrome
Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec)

History of significant bleeding disorder unrelated to cancer, including:

Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
Ongoing or recent (=< 3 months) significant gastrointestinal bleeding
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

Men and women who:

Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or women who:

Have a positive pregnancy test at baseline, or
Are pregnant or breastfeeding