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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Topotecan
* Drug: Belotecan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Belotecan<br>Camtobell Injection | Drug: Belotecan<br>* 0.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more<br>* Other names: Camtobell Injection;|
| Active Comparator: Topotecan<br>Hycamtin Injection | Drug: Topotecan<br>* 1.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more<br>* Other names: Hycamtin Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objectives Response Rate(ORR, %) | The response rate was defined as the test subject who had a complete response (CR) or a partial response (PR) as determined by the 'tumor response evaluation' criteria specified in the research protocol | Up to 18weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) | Defined as the time from the randomization to the time of death. | 7years | 
| Progression Free survival(PFS) | Defined as the elapsed time from the time of randomization to the time of confirmation of progression or the time of death | Up to 18weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small Cell Lung Cancer, Belotecan, Topotecan