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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.

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  

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




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