Safety of Everolimus and Pemetrexed in Lung Cancer Patients

A Phase I Study Investigating the Combination of Everolimus With Pemetrexed in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy

This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.

Inclusion criteria:

• Lung cancer
• Only one prior regimen of chemotherapy for the treatment of non small cell lung cancer
• Adequate bone marrow function
• Adequate liver function
• Adequate renal function
• Negative serum pregnancy test

Exclusion criteria:

• History of another primary malignancy in the last 5 years
• Having recently received an investigational drug
• Having recently received major surgery of wide field radiotherapy
• Chronic treatment with immunosuppressive therapy, steroids or liver enzyme modulators
• Severe or uncontrolled medical conditions

Other protocol-defined inclusion/exclusion criteria may apply