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

Sponsor:	Merck KGaA
Information provided by:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT00148798

Purpose

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.

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: cetuximab + cisplatin + vinorelbine Drug: cisplatin + vinorelbine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Vinorelbine Vinorelbine tartrate Cetuximab

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	1125
Study Start Date:	October 2004
Estimated Study Completion Date:	July 2010
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: cetuximab + cisplatin + vinorelbine cetuximab given as an i.v. infusion every week (400mg/m2 initial dose and 250mg/m2 subsequent doses) until PD + cisplatin 80mg/m2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m2 i.v. infusion on days 1 and 8 of each 3-week cycle.
2: Active Comparator	Drug: cisplatin + vinorelbine cisplatin 80mg/m2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m2 i.v. infusion on days 1 and 8 of each 3-week cycle.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148798

Show 118 Study Locations

Sponsors and Collaborators

Merck KGaA

Investigators

Principal Investigator:

Robert Pirker, Professor

Universitätsklinik für Innere Medizin I, Wien

More Information

No publications provided

Responsible Party:	Merck KGaA ( Luisa Lucas, Clinical Trial Leader )
Study ID Numbers:	EMR 62202-046
Study First Received:	September 7, 2005
Last Updated:	January 25, 2010
ClinicalTrials.gov Identifier:	NCT00148798 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Merck KGaA:

Cetuximab
Non small cell lung cancer
Lung cancer

Cisplatin/vinorelbine
Monoclonal antibody
Erbitux

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vinblastine
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Cetuximab

Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Vinorelbine
Radiation-Sensitizing Agents
Lung Diseases
Tubulin Modulators
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010