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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Figitumumab | Monoclonal antibody | 20 mg/kg | — |
| Comparator | Cisplatin | Other / unclassified | 80 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | — |