NCT00148798

Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)

Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,861 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.

Conditions

• Non Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	cetuximab + cisplatin + vinorelbine	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
DRUG	cisplatin + vinorelbine	cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-07-01
• Completion: 2012-05-01
• First posted: 2005-09-08
• Last updated: 2014-06-25
• Results posted: 2011-10-04

Locations

118 sites across 28 countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Czechia, France, Germany, Hong Kong, Hungary, Ireland, Italy, Mexico, Netherlands, Poland, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom