Full Text View
Tabular View
No Study Results Posted
Related Studies
Study of Cisplatin/Vinorelbine +/- Cetuximab as First-Line Treatment of Advanced Non Small Cell Lung Cancer(FLEX)
This study has been completed.
First Received: September 7, 2005   Last Updated: March 21, 2009   History of Changes
Sponsored by: 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:


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: 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

No publications provided

Responsible Party: Merck KGaA ( Isil Montaner )
Study ID Numbers: EMR 62202-046
Study First Received: September 7, 2005
Last Updated: March 21, 2009
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

Study placed in the following topic categories:
Thoracic Neoplasms
Cetuximab
Vinblastine
Antimitotic Agents
Carcinoma
Antibodies, Monoclonal
Antibodies
Vinorelbine
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Immunoglobulins
Neoplasms, Glandular and Epithelial

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 July 02, 2009