NCT01109524

Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer

Cisplatin and Vinorelbine in Combination With Cetuximab as First Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC): a Single Arm Multicenter Safety Phase 2 Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.

Conditions

• Lung Neoplasms
• Carcinoma
• Cancer of the Lung
• Non-Small-Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Cetuximab	Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision
DRUG	Cisplatin	Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles
DRUG	Vinorelbine	Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-04-23
• Last updated: 2015-12-24
• Results posted: 2013-12-10

Locations

22 sites across 3 countries: United States, Canada, Puerto Rico