A Study for Non-Smoker Patients With Nonsquamous Non-Small Cell Lung Cancer

A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed Alone, and Erlotinib Alone, as Second-Line Treatment for Non-Smoker Patients With Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer

The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.

Inclusion Criteria:

• Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
• Patients must be non-smokers
• Patients must have at least one measurable lesion
• Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale
• Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.

Exclusion Criteria:

• Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
• Patients who have previously received treatment with drugs against the human epidermal growth factor receptors
• Patients who have previously received treatment with drugs which have similar targets as Pemetrexed
• Patients who have any known significant ophthalmologic abnormalities of the surface of the eye
• Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed