Phase 1b Trial of RAD001 in Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

This is a Phase 1b randomized, pre-operative lung cancer trial wherein patients with
operable lung cancer will be treated with RAD001 for 3-4 weeks to study the effects of the
novel agent in relevant molecular pathways. The study will also assess the FDG uptake of the
tumor at baseline and upon completion of therapy (before surgery) with a PET scan . The
safety profile of RAD001 will also be evaluated.

New agents and regimens are urgently needed for lung cancer treatment. With the development
of novel agents and small molecules designed to curtail the aggressive aspects of this
disease, some progress has been realized. However, much more effort and insight will be
required for further real gains to be made. We propose that studying the mTOR axis, known
to be abnormal in non-small cell lung cancer (NSCLC), and translating that knowledge into
therapeutic adjustments can lead to meaningful advances in lung cancer treatment.

Approximately 35 patients will participate at Winship Cancer Institute of Emory University
in Atlanta, Georgia.

Inclusion Criteria:

- Patient must have histologically confirmed Stage I-IIIA non-small cell lung cancer
(NSCLC) which is accessible to biopsy.

- ECOG Performance Status of 0, 1, or 2.

- Life-expectancy greater than 6 months.

- Adequate bone marrow, renal, hepatic, pulmonary and cardiac function as defined in
the protocol.

- Patient must be at least 18 years of age.

- Must meet pre-entry requirements for timing of study parameters as specified in
section 7.0.

- Female patients of child-bearing potential must have a negative serum pregnancy test
within 48 hours of study initiation and be non-lactating.

- 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.

- The use of G-CSF will be permitted in study participants.

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

Exclusion Criteria:

- Patient has received previous treatment for NSCLC.

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

- Patient is pregnant or breast-feeding.

- Patient has incurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Patient is unable to swallow RAD001 tablet.

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

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