Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer

A Randomised, Open-Label Phase 3 Trial Comparing Amrubicin Versus Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy

The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the treatment of non-small cell lung cancer (NSCLC).

Inclusion Criteria:

• Histological or cytological diagnosis of non-small cell lung cancer (NSCLC)
• 1 or 2 prior chemotherapy regimen including 1 platinum-based chemotherapy
• 20 or older but younger than 75 years of age

Exclusion Criteria:

• Symptomatic brain metastasis
• Interstitial pneumonia or pulmonary fibrosis
• Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
• Active infection