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

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

This study has been completed.
Information provided by EMD Pharmaceuticals

This Tabular View shows the required WHO registration data elements as marked by ^†

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.

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 ]

Condition ^†

Non Small Cell Lung Cancer

Intervention ^†

Drug: cetuximab + cisplatin + vinorelbine
Drug: cisplatin + vinorelbine

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

1125

Start Date ^†

November 2004

Completion Date

July 2007

Eligibility Criteria ^†

Inclusion Criteria:

Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIb with documented malignant pleural effusion or stage IV
Immunohistochemical evidence of EGFR expression on tumor tissue
Presence of at least 1 bi-dimensionally measurable index lesion, whereby index lesions must not lie in an irradiated area

Exclusion Criteria:

Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR-targeting therapy
Previous chemotherapy for NSCLC
Documented or symptomatic brain metastasis
Superior vena cava syndrome contra-indicating hydration
Previous malignancy in the last 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

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 ^†

Principal Investigator:

Robert Pirker, Professor

Universitätsklinik für Innere Medizin I, Wien

Information Provided By

EMD Pharmaceuticals

Verification Date

December 2007

First Received Date ^†

September 7, 2005

Last Updated Date

December 13, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.