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

Phase 3 Completed 300 enrolled Marubeni Pharmaceuticals (Suzhou) Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2008-04
Primary completion: 2012-02
Completion: 2012-08

Outcome

Met primary endpoint

paper demonstrating non-inferiority of AP to EP (AP group: 95% confidence interval for hazard ratio 0.63-1.03 months). PMID 27061082 ↗

release “non-inferiority of the amrubicin-cisplatin combination vs the cisplatin-etoposide combination was demonstrated at the primary endpoint of "overall survival".” sumitomo-pharma.com ↗

Publications

Sun Y, Cheng Y, Hao X, Wang J, Hu C, Han B, Liu X, Zhang L, Wan H, Xia Z, Liu Y, Li W, Hou M, Zhang H, Xiu Q, Zhu Y, Feng J, Qin S, Luo X. Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer. BMC Cancer. 2016 Apr 9;16:265. doi: 10.1186/s12885-016-2301-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amrubicin	Small molecule	40 mg/m2	—
Subject	Cisplatin	Other / unclassified	60 mg/m2	—
Subject	Cisplatin	Other / unclassified	80 mg/m2	—
Comparator	Etoposide	Small molecule	100 mg/m2	—