Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer

Study Overview
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Brief Summary
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This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.

Official Title
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Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Amrubicin Hydrochloride
* Drug: Etoposide-Cisplatin combined chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically/cytologically proven small cell lung cancer Extensive disease No prior chemotherapy regimen Age 18 years or older ECOG performance status of 0-1 Exclusion Criteria: Brain metastasis requiring treatment Treatment (Surgical or radiotherapy)of primary tumor Interstitial pneumonia or pulmonary fibrosis Abnormal cardiac function or myocardial infraction within 6 months before study enrollment

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: 1<br>Amrubicin Hydrochloride-Cisplatin combined chemotherapy | Drug: Amrubicin Hydrochloride<br>* Amrubicin Hydrochloride combined with cisplatin<br>|
| Active Comparator: 2<br>Etoposide-Cisplatin combined chemotherapy | Drug: Etoposide-Cisplatin combined chemotherapy<br>* combined chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 1.5 years after last subject enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival |  | 1.5 years after last subject enrolled | 
| Objective Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | participants were followed for the duration of the study, an average of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extensive Disease-Small Cell Lung Cancer