Conditions: Non Small Cell Lung Cancer (NSCLC)
Keywords: Cetuximab Non small cell lung cancer Lung cancer Cisplatin/vinorelbine Monoclonal antibody Erbitux
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1861
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: cetuximab + cisplatin + vinorelbine arm 2: cisplatin + vinorelbine alone

Interventions: intervention 1: cetuximab + cisplatin + vinorelbine intervention 2: cisplatin + vinorelbine
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: