Conditions: Non-small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.

Detailed description:

Arms:
arm 1: Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. arm 2: Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.

Interventions: intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Gefitinib
Intervention descriptions: intervention 1: 500 milligrams per meter squared (mg/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity. intervention 2: 75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity intervention 3: 250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity

Protocol document: