Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC

Summary

The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy. The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.

Timeline

Start

2009-03

Primary completion

2012-09

Completion

2015-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Randomization Phase: Volasertib 300 mg vs Randomization Phase: Pemetrexed 500 mg/m2; p = 0.0030; Hazard Ratio (HR) 2.045 (95% CI 1.271 to 3.292); Log Rank NCT00824408 ↗

registry analysis (superiority or other test); Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 vs Randomization Phase: Pemetrexed 500 mg/m2; p = 0.2804; Hazard Ratio (HR) 1.141 (95% CI 0.735 to 1.771); Log Rank NCT00824408 ↗

Publications

• Ellis PM, Leighl NB, Hirsh V, Reaume MN, Blais N, Wierzbicki R, Sadrolhefazi B, Gu Y, Liu D, Pilz K, Chu Q. A Randomized, Open-Label Phase II Trial of Volasertib as Monotherapy and in Combination With Standard-Dose Pemetrexed Compared With Pemetrexed Monotherapy in Second-Line Treatment for Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2015 Nov;16(6):457-65. doi: 10.1016/j.cllc.2015.05.010. Epub 2015 Jun 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Pemetrexed	Small molecule	500 mg/m2	Intravenous
Subject	Volasertib	Small molecule	300 mg	Intravenous

Indications