Conditions: Non-Small Cell Lung Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 52
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.

Detailed description:

Arms:
arm 1: Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity. arm 2: Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.

Interventions: intervention 1: erlotinib [Tarceva]
Intervention descriptions: intervention 1: Erlotinib tablets taken orally once daily in the morning.

Protocol document: