Open Label, Non-randomized, Phase 2 Study Investigating the Effect of RAD001 Monotherapy in Patients With Advanced NSCLC Previously Treated With Either Chemotherapy Only or With Chemotherapy and EGFR Inhibitor(s)

Inclusion Criteria:

- Patients with advanced (unresectable or metastatic) NSCLC

- Tissue sample of the metastatic or primary tumor available for pathology evaluation
and molecular marker analyses

- Patients who have received ≤ 2 chemotherapy regimens, one of which must have included
cisplatinum or carboplatin, and who have documented evidence of tumor progression
(Arm 1)

- Patients who have received ≤ 2 chemotherapy regimens, one of which must have included
cisplatinum or carboplatin as well as a small molecule EGFR inhibitor (as a
separate regimen) with documented tumor progression despite at least 4 weeks therapy
with either gefitinib or erlotinib (Arm 2)

Exclusion Criteria:

- Concurrent therapy with agents used otherwise as anticancer therapy (for example,
methotrexate for rheumatoid arthritis)

- Any investigational drug, other than EGFR inhibitor (Arm 2), within the preceding 4
weeks

- Chronic treatment with steroids or another immunosuppressive agent

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

Other protocol-defined inclusion/exclusion criteria may apply