Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)

Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer

The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.

Inclusion Criteria:

• Extensive-disease small-cell lung cancer
• Aged 70 years or older
• Performance status of 0-2
• No prior chemotherapy

Exclusion Criteria:

• Prior therapy for primary lesion
• Pneumonitis and/or pulmonary fibrosis
• Active concomitant malignancy