|Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer|
|Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology|
|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).|
This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 [figitumumab] to erlotinib [Tarceva] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.
This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
- Carcinoma, Large Cell
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Squamous Cell
- Carcinoma, Adenosquamous Cell
- Drug: CP 751,871 (Figitumumab)
CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.
- Drug: Erlotinib
Erlotinib (one tablet of 150 mg/day PO).
- Drug: Erlotinib
Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.
|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.|
|March 2011 (Final data collection date for primary outcome measure)|
- Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.
- Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
- Prior Erlotinib therapy.
- Prior anti IGF IR based investigational therapy.
|Sexes Eligible for Study:||All|
|18 Years and older (Adult, Older Adult)|
|Contact information is only displayed when the study is recruiting subjects|
|Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, France, Greece, Hungary, Indonesia, Ireland, Italy, Korea, Republic of, Latvia, Poland, Puerto Rico, Romania, Russian Federation, Serbia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|