Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC

Phase 3 Completed 718 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed will be obtained.

Timeline

Start: 2008-12
Primary completion: 2011-06
Completion: 2015-12

Publications

Lesaffre E, Edelman MJ, Hanna NH, Park K, Thatcher N, Willemsen S, Gaschler-Markefski B, Kaiser R, Manegold C. Statistical controversies in clinical research: futility analyses in oncology-lessons on potential pitfalls from a randomized controlled trial. Ann Oncol. 2017 Jul 1;28(7):1419-1426. doi: 10.1093/annonc/mdx042.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nintedanib	Small molecule	200 mg	Oral
Comparator	B12	Other / unclassified	1000 ug	Intramuscular
Background	Dexamethasone	Small molecule	4 mg	Oral
Background	Pemetrexed	Small molecule	500 mg/m2	Intravenous
Comparator	folic acid	Other / unclassified	400 ug	—

Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC

Summary

Timeline

Publications

Drugs

Indications