Trial Information
Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival Time (OS)
Outcome Description:
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Outcome Time Frame:
Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Safety Issue:
No
Principal Investigator
Robert Pirker, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universitätsklinik für Innere Medizin I, Wien
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
EMR 62202-046
NCT ID:
NCT00148798
Start Date:
October 2004
Completion Date:
May 2012
Related Keywords:
- Non Small Cell Lung Cancer (NSCLC)
- Cetuximab
- Non small cell lung cancer
- Lung cancer
- Cisplatin/vinorelbine
- Monoclonal antibody
- Erbitux
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms