At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed NSCLC, stage IIIb with malignant pleural effusion or stage IV
- ✓EGFR expression documented by immunohistochemistry on tumor tissue
- ✓At least 1 bi-dimensionally measurable index lesion not in an irradiated area
- ✕Prior monoclonal antibodies, signal transduction inhibitors, or EGFR-targeting therapy
- ✕Prior chemotherapy for NSCLC
- ✕Documented or symptomatic brain metastasis
- ✕Superior vena cava syndrome contra-indicating hydration
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating cetuximab + cisplatin + vinorelbine and cisplatin + vinorelbine for Non Small Cell Lung Cancer (NSCLC). Completed, enrolled 1,861 participants across 118 sites in 28 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.