Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 755
Healthy volunteers: no

Brief summary:
The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.

Detailed description:

Arms:
arm 1: Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks. arm 2: A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

Interventions: intervention 1: Paclitaxel (Taxane) intervention 2: Docetaxel (Taxane) intervention 3: Carboplatin intervention 4: Cetuximab
Intervention descriptions: intervention 1: IV, 225 mg/m\^2 intervention 2: IV, 75 mg/m\^2 intervention 3: AUC=6, q 3 weeks (6 cycles maximum) intervention 4: Intravenous, 400 mg/m\^2, initial dose followed by 250 mg/m\^2, weekly starting on Week 2

Protocol document: