A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Woman and Man

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Extract

The primary objective is to demonstrate superiority in overall survival of amrubicin (40 mg/square metre administered as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course) compared with topotecan (1.5 mg/square metre administered as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course) in patients with extensive or limited and sensitive or refractory small cell lung cancer (SCLC) after failure of first-line chemotherapy.

Inclusion criteria

Extensive or limited and sensitive or refractory SCLC after failure of first-line chemotherapy

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A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of Fir...