Nedaplatin (Jiebaishu®) Combined With Docetaxel for Advanced Lung Squamous Cell Carcinoma

Summary

The treatment of squamous cell carcinoma of lung has not improved suffuciently. Nedaplatin is a second-generation platinum compound that is more active against squamous cell carcinoma of the lung with a response rate of 60%, issued by the finished Phase II trial in Japan.

Timeline

Start

2013-12

Primary completion

2016-10

Completion

2017-02

Outcome

Missed primary endpoint

paper There is no improvement in PFS with the nedaplatin and docetaxel combination in the intent-to-treat analysis. PMID 30017831 ↗

paper median PFS was 4.63 months (95% confidence interval: 4.43-5.10) for the ND and 4.23 months (95% confidence interval: 3.37-4.53) for CD groups (p = 0.056). PMID 30017831 ↗

Publications

• Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, Zhao Q, Fan Y, Wu G, Ma Z, Fang J, Yu Q, Liu Z. Nedaplatin Plus Docetaxel Versus Cisplatin Plus Docetaxel as First-Line Chemotherapy for Advanced Squamous Cell Carcinoma of the Lung - A Multicenter, Open-label, Randomized, Phase III Trial. J Thorac Oncol. 2018 Nov;13(11):1743-1749. doi: 10.1016/j.jtho.2018.07.006. Epub 2018 Jul 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Comparator	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Nedaplatin	Small molecule	80 mg/m2	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous

Indications