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| Descriptive Information Fields | |||||
| Brief 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 EGFR-Expressing Advanced NSCLC. | ||||
| Brief 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. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Overall survival time [ Time Frame: various timepoints ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Progression-free survival time [ Time Frame: various timepoints ] [ Designated as safety issue: No ] Response rate [ Time Frame: various ] [ Designated as safety issue: No ] Disease control rat [ Time Frame: various timepoints ] [ Designated as safety issue: No ] Safety [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ] Quality of life [ Time Frame: various timepoints ] [ Designated as safety issue: No ] Pharmacokinetics [ Time Frame: various timepoints ] [ Designated as safety issue: No ] |
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| Condition † | Non Small Cell Lung Cancer | ||||
| Intervention † | Drug: cetuximab + cisplatin + vinorelbine Drug: cisplatin + vinorelbine |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 1125 | ||||
| Start Date † | November 2004 | ||||
| Completion Date | July 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, Ireland, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00148798 | ||||
| Organization ID | EMR 62202-046 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Merck KGaA | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | EMD Pharmaceuticals | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | September 7, 2005 | ||||
| Last Updated Date | December 13, 2007 | ||||