Conditions: Carcinoma, Non-Small-Cell Lung
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

Brief summary:
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no EGFR mutations.

Detailed description:

Arms:
arm 1: patient to receive tablets of BIBW 2992 once a day, starting at high dose until progression of the disease arm 2: patient whose disease progressed on treatment with BIBW 2992 monotherapy to receive tablet of BIBW 2992 once a day in combination with i.v. paclitaxel 3 weekly

Interventions: intervention 1: BIBW2992 intervention 2: BIBW2992 + paclitaxel
Intervention descriptions: intervention 1: tablet BIBW high dose intervention 2: tablet BIBW 2992 in combination with i.v. paclitaxel 3 weekly

Protocol document: