| Exclusion Criteria: | 1) Concurrent therapy with agents otherwise used in treatment of cancer (for example, methotrexate for rheumatoid arthritis)
2) Treatment with any other investigational drugs within the preceding 4 weeks
3) Prior treatment with an EGFR inhibitor (either a small molecule EGFR TK inhibitor or anti-EGFR antibody)
4) Chronic treatment with steroids or another immunosuppressive agent
5) Leptomeningeal or uncontrolled brain metastases, including patients who continue to require glucocorticoids or intrathecal chemotherapy for brain or leptomeningeal metastases (documented by lumbar puncture)
6) Malignancies other than lung cancer within the past 2 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
7) Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration)
8) A known history of HIV or previous seropositivity for the virus
9) Patients with active skin, mucosa, ocular or GI disorders of grade > 1
10) Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 or erlotinib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
11) Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
12) Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001 or erlotinib)
13) History of noncompliance to medical regimens
14) Patients unwilling to or unable to comply with the protocol |