Know Cancer

or
forgot password

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.


Phase 3
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer (NSCLC)

Thank you

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:

Universit├Ątsklinik f├╝r 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

Name

Location