Title
Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC
Phase
Phase 3Lead Sponsor
SumitomoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Lung CancerStudy Participants
300This 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.
Amrubicin Hydrochloride combined with cisplatin
combined chemotherapy
Etoposide-Cisplatin combined chemotherapy
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
| Event Type | Organ System | Event Term | Amrubicin, Anticancer, Injection | Etoposide, Anticancer, Injection |
|---|
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.
