Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC

This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival [PFS], disease control rate, best response rate, time to treatment failure [TTTF], overall survival [OS] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

Inclusion Criteria:

• Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy.
• Failure of previous treatment with one prior platinum-based chemotherapy regimen.
• Good performance status.
• Adequate bone marrow reserve, renal and hepatic functions.

Exclusion Criteria:

• Serious concomitant systemic disease.
• Inability to take oral medication.
• Inability or unwillingness to take vitamin supplementation and corticosteroids.
• Pregnancy / Breast-feeding.
• Treatment with certain medicines that prevent blood from clotting.