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

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

ChemIDplus related topics:

Cisplatin Vinorelbine Vinorelbine tartrate 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
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:

Antibodies, Monoclonal

Thoracic Neoplasms

Antibodies

Non-small cell lung cancer

Vinorelbine

Cisplatin

Lung Neoplasms

Lung Diseases

Cetuximab

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Radiation-Sensitizing Agents

Respiratory Tract Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	Merck KGaA
Information provided by:	EMD Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00148798