Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer

Summary

The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination with docetaxel compared to docetaxel alone in participants with non-small cell lung cancer who were previously treated with first line chemotherapy.

Timeline

Start

2010-05

Primary completion

2011-12

Completion

2012-06

Outcome

Missed primary endpoint

registry MEAN LY2181308 + Docetaxel: 1.06 (Standard Deviation 0.2) Log Ratio of Tumor Size NCT01107444 ↗

registry MEAN Docetaxel: 1.01 (Standard Deviation 0.13) Log Ratio of Tumor Size NCT01107444 ↗

registry analysis (unspecified test); LY2181308 + Docetaxel vs Docetaxel; p = 0.284; t-test, 1 sided; NCT01107444 ↗

paper suggesting no significant improvement in antitumor activity between the arms. PMID 25436803 ↗

Publications

• Natale R, Blackhall F, Kowalski D, Ramlau R, Bepler G, Grossi F, Lerchenmuller C, Pinder-Schenck M, Mezger J, Danson S, Gadgeel SM, Summers Y, Callies S, Andre V, Das M, Lahn M, Talbot D. Evaluation of antitumor activity using change in tumor size of the survivin antisense oligonucleotide LY2181308 in combination with docetaxel for second-line treatment of patients with non-small-cell lung cancer: a randomized open-label phase II study. J Thorac Oncol. 2014 Nov;9(11):1704-8. doi: 10.1097/JTO.0000000000000285.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	GATAPARSEN	Antisense oligonucleotide	750 mg	Intravenous

Indications