Clinical trial
Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced…
NCT00148798 · Merck KGaA, Darmstadt, Germany, Industry · Completed
Key facts
| NCT number | NCT00148798 |
|---|---|
| Title | Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX) |
| Official title | 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. |
| Acronym | FLEX |
| Lead sponsor | Merck KGaA, Darmstadt, Germany, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Non Small Cell Lung Cancer (NSCLC) |
| Intervention type | Drug |
| Interventions | cetuximab + cisplatin + vinorelbine, cisplatin + vinorelbine |
| Enrollment | 1,861 |
| Start date | Oct 1, 2004 |
| Primary completion | Jul 1, 2007 |
| Completion | May 1, 2012 |
| First posted | Sep 8, 2005 |
| Last update posted | Jun 25, 2014 |
| Countries | Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Czechia, France, Germany, Hong Kong, Hungary and 16 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: