NCT00596830

Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology

Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 681 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

Detailed description

The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 \[figitumumab\] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.

Conditions

• Carcinoma, Squamous Cell
• Carcinoma, Adenosquamous
• Carcinoma, Large Cell
• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	CP-751,871 (Figitumumab)	CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.
DRUG	Carboplatin	Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.
DRUG	Paclitaxel	Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.
DRUG	Carboplatin	Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.
DRUG	Paclitaxel	Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-03-01
• Completion: 2012-09-01
• First posted: 2008-01-17
• Last updated: 2014-01-13
• Results posted: 2013-12-03

Locations

280 sites across 26 countries: United States, Australia, Austria, Brazil, Bulgaria, Canada, Czechia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Poland, Puerto Rico, Russia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine