Conditions: Carcinoma, Non-Small Cell Lung
Keywords: non-squamous NSCLC axitinib pemetrexed/cisplatin
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 180
Healthy volunteers: no

Brief summary:
AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).

Detailed description:

Arms:
arm 1: Axitinib (continuous) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance arm 2: Axitinib (modified) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance arm 3: pemetrexed and cisplatin arm 4: Axitinib interrupted before each chemo cycle (Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance arm 5: pemetrexed and cisplatin

Interventions: intervention 1: axitinib intervention 2: axitinib intervention 3: chemotherapy intervention 4: axitinib intervention 5: chemotherapy
Intervention descriptions: intervention 1: 5mg BID po up to max 10mg BID po intervention 2: 5mg BID po up to max 10mg BID po paused for 3 days before each cycle of concomitant chemotherapy intervention 3: Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles intervention 4: 5mg BID po up to max 10mg BID po paused before each concomitant chemotherapy intervention 5: Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles

Protocol document: