drugset / Trial / NCT00907504

Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

NCT00907504

Phase 3 Withdrawn Pfizer
RandomizedParallel-groupOpen-labelTreatment

Summary

Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.

Timeline

Start
2010-07
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Figitumumab Monoclonal antibody 20 mg/kg
Comparator Cisplatin Other / unclassified 80 mg/m2
Comparator Gemcitabine Small molecule 1250 mg/m2