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

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

September 2, 2009

Start Date ^ICMJE

November 2004

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall survival time [ Time Frame: various timepoints ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Overall suvival time

Change History

Complete list of historical versions of study NCT00148798 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Progression-free suvival time
Response rate
Disease control rat
Safety
Quality of life
Pharmacokinetics

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Non Small Cell Lung Cancer

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

1125

Completion Date

May 2007

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

NCT ID ^ICMJE

NCT00148798

Responsible Party

Luisa Lucas, Clinical Trial Leader, Merck KGaA

Study ID Numbers ^ICMJE

EMR 62202-046

Study Sponsor ^ICMJE

Merck KGaA

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Robert Pirker, Professor

Universitätsklinik für Innere Medizin I, Wien

Information Provided By

Merck KGaA

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP