Conditions: Non-Small Cell Lung Cancer
Keywords: Tarceva NSCLC EGFR ECOG Performance Status 2 erlotinib Non-Small Cell Lung Cancer OSI-774
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 103
Healthy volunteers: no

Brief summary:
The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

Detailed description:

Arms:
arm 1: Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy arm 2: Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

Interventions: intervention 1: Tarceva (Trademark) (erlotinib HCl, OSI-774) intervention 2: Combination carboplatin and paclitaxel
Intervention descriptions: intervention 1: Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy intervention 2: Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

Protocol document: