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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. (FLEX)
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.
Details
| Lead sponsor | Merck KGaA, Darmstadt, Germany |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1861 |
| Start date | 2004-10 |
| Completion | 2012-05 |
Conditions
- Non Small Cell Lung Cancer (NSCLC)
Interventions
- cetuximab + cisplatin + vinorelbine
- cisplatin + vinorelbine
Primary outcomes
- Overall Survival Time (OS) — Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
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