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

Sumitomo Pharma (Suzhou) Co., Ltd.300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Lung Cancer

Interventions

Amrubicin HydrochlorideDRUG

Amrubicin Hydrochloride combined with cisplatin

Etoposide-Cisplatin combined chemotherapyDRUG

combined chemotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Unnamed facility

Fuzhou, Fujian, China

Unnamed facility

Lanzhou, Gansu, China

Unnamed facility

Guangzhou, Guangdong, China

Unnamed facility

Changsha, Hunan, China

Outcomes

Primary Outcomes

Overall Survival

Time frame: 1.5 years after last subject enrolled

Secondary Outcomes

Progression-Free Survival

Time frame: 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.

Time frame: participants were followed for the duration of the study, an average of 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.