Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

Phase 3 Terminated 583 enrolled Pfizer

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Timeline

Start: 2008-05
Primary completion: 2011-03
Completion: 2012-04

Outcome

Missed primary endpoint

Stopped: “See termination reason in detailed description.”

registry MEDIAN Figitumumab + Erlotinib: 5.7 (4.8 to 6.7) months NCT00673049 ↗

registry MEDIAN Erlotinib: 6.2 (5.8 to 7.2) months NCT00673049 ↗

registry Figitumumab + Erlotinib vs Erlotinib; p = 0.35; Hazard Ratio (HR) 1.091 (95% CI 0.909 to 1.310); Log Rank NCT00673049 ↗

Publications

Scagliotti GV, Bondarenko I, Blackhall F, Barlesi F, Hsia TC, Jassem J, Milanowski J, Popat S, Sanchez-Torres JM, Novello S, Benner RJ, Green S, Molpus K, Soria JC, Shepherd FA. Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with nonadenocarcinoma nonsmall-cell lung cancer. Ann Oncol. 2015 Mar;26(3):497-504. doi: 10.1093/annonc/mdu517. Epub 2014 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Erlotinib	Small molecule	150 mg	Oral
Subject	Figitumumab	Monoclonal antibody	20 mg/kg	Intravenous