Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer

Inclusion Criteria:

- Patients must have histologically confirmed non-small cell lung cancer (NSCLC) which
is accessible to biopsy.

- Patient must have ECOG Performance Status of 0, 1, or 2.

- Life expectancy greater than 12 weeks.

- Patient must have adequate bone marrow, renal and hepatic function as defined in the
protocol.

- Completed all prior therapy at least 3 weeks prior to registration and be adequately
recovered from that therapy.

- Must be at least 18 years of age.

- Meet pre-entry requirements as specified in Section 7.0.

- Female patients of child-bearing potential must have a negative serum pregnancy test
prior to study entry.

- Patients of child-bearing potential must agree to use an effective form of
contraception while on study and for 3 months following completion of study
treatment.

- Patient must not have more than one prior chemotherapy regimen.

- Final eligibility for a clinical trial is determined by the health professionals
conducting the trial.

Exclusion Criteria:

- Chronic treatment with systemic steroids or other immunosuppressive agents.

- Uncontrolled brain or leptomeningeal metastases, including patients who continue to
require glucocorticoids for brain or leptomeningeal metastases.

- A known history of HIV seropositivity.

- Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled
nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).

- Patients with an active, bleeding diathesis or an oral anti-vitamin K medication
(except low dose coumadin).

- Known hypersensitivity to everolimus, sirolimus, or any of its excipients.

- Patient is pregnant or breast-feeding.

- Patient has intercurrent illness including, but not limited to: ongoing active or
severe infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, uncontrolled hypertension, myocardial infarction within 6 months,
uncontrolled diabetes mellitus, chronic liver or renal disease, active upper GI tract
ulceration or psychiatric illness/social situations that would limit compliance with
study requirements.

- Patient is unable to swallow RAD001.

- History of other invasive malignancies, with the exception of non-melanoma skin
cancer, if there is any evidence of the malignancy being present within the past 5
years.

- History of severe hypersensitivity reaction to docetaxel or other drugs formulated
with polysorbate 80. Symptoms may include any reaction such as bronchospasm,
generalized urticaria, systolic BP ≤ 80mm Hg, and angioedema.

- Patient has received treatment with an investigational agent within 4 weeks of
registration.

- Final eligibility for a clinical trial is determined by the health professionals
conducting the trial.