A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer

A Phase IIb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Relapsed Small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.

A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell inj.) or Topotecan in Patients with Relapsed Small Cell Lung Cancer

Inclusion Criteria:

• At least 18 years of age
• Histological or cytological diagnosis of SCLC
• Limited disease (LD) or Extensive disease (ED) at time of study entry
• Recurrent or progressive SCLC ≥ 90 days of duration of response for firstline therapy
• Measurable disease defined by RECIST criteria
• ECOG Performance Status of 0, 1, or 2
• Life expectancy ≥ 3 months
• Adequate bone marrow, Renal, Hepatic reserve:

absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/mm3 platelet count ≥ 100,000 cells/ mm3 hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 mm3 Alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤ 2.0 X ULN Alkaline Phosphatase (ALP) ≤ 2.0 X ULN Serum creatinine ≤ 1.5mg/dL or calculated creatinine clearance > 60mL/min

- Signed a written informed consent

Exclusion Criteria:

• Active infection
• Symptomatic brain lesion
• Any other type of cancer during the previous 5 years
• Severe concurrent diseases
• Prior anticancer therapy within 4 weeks before enroll
• Active pregnancy test and Pregnant or nursing women
• Participation in any investigational drug study within 28 days prior to study entry