Conditions: Non-Small-Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 247
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.

Detailed description:

Arms:
arm 1: Pemetrexed 500 milligrams per meter squared (mg/m\^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months. arm 2: Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months. arm 3: Pemetrexed 500 mg/m\^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.

Interventions: intervention 1: pemetrexed intervention 2: erlotinib
Intervention descriptions: intervention 1: 500 milligrams per meter squared (mg/m\^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops intervention 2: 150 mg, orally, once daily until progression or unacceptable toxicity develops

Protocol document: