Conditions: Carcinoma, Non-Small-Cell Lung Adenocarcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 345
Healthy volunteers: no

Brief summary:
This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.

Detailed description:

Arms:
arm 1: BIBW 2992 tablet once daily until progression arm 2: Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles

Interventions: intervention 1: Pemetrexed intervention 2: BIBW 2992 intervention 3: Cisplatin
Intervention descriptions: intervention 1: Pemetrexed IV given once every 3 weeks for up to 6 cycles intervention 2: BIBW 2992 once daily until progression intervention 3: Cisplatin IV given once every 3 weeks for up to 6 cycles

Protocol document: