Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient

Phase 3 Completed 147 enrolled Chonnam National University Hospital Chong Kun Dang Pharmaceutical · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer. Primary endpoints * to assess Response Rate Secondary endpoints * to assess Overall response duration, Time to progression, Overall survival

Timeline

Start: 2009-01
Primary completion: 2013-02
Completion: 2013-02

Outcome

Met primary endpoint

paper The RR in the BP arm was non-inferior to the EP regimen PMID 27566413 ↗

paper meeting the predefined non-inferiority criterion of -15.0 %. PMID 27566413 ↗

Publications

Oh IJ, Kim KS, Park CK, Kim YC, Lee KH, Jeong JH, Kim SY, Lee JE, Shin KC, Jang TW, Lee HK, Lee KY, Lee SY. Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial. BMC Cancer. 2016 Aug 26;16(1):690. doi: 10.1186/s12885-016-2741-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belotecan	Small molecule	0.5 mg/m2	—
Comparator	Etoposide	Small molecule	100 mg/m2	—
Background	Cisplatin	Other / unclassified	60 mg/m2	—