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

Sponsored by:	Merck KGaA
Information provided by:	EMD Pharmaceuticals
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

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Vinorelbine Vinorelbine tartrate Immunoglobulins Globulin, Immune Cetuximab

U.S. FDA Resources

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.

Further study details as provided by EMD Pharmaceuticals:

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:	November 2004
Study Completion Date:	July 2007

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

Responsible Party:	Merck KGaA ( Isil Montaner )
Study ID Numbers:	EMR 62202-046
Study First Received:	September 7, 2005
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00148798
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by EMD Pharmaceuticals:

Cetuximab
Non small cell lung cancer
Lung cancer

Cisplatin/vinorelbine
Monoclonal antibody
Erbitux

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Cetuximab
Vinblastine
Carcinoma
Antibodies, Monoclonal
Antibodies
Vinorelbine

Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009