BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)

Inclusion criteria:

Patients with pathologic confirmation of NSCLC Stage III-B (with pleural effusion) or Stage IV adenocarcinoma who have failed at least one but not more than two lines of cytotoxic chemotherapy (including adjuvant chemotherapy). One of the chemotherapy regimens must have been platinum-based.
Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2
Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as >20 mm using conventional techniques or >10 mm with spiral CT scan
Male and female patients age >18 years
Life expectancy of at least three (3) months
Written informed consent that is consistent with ICH-GCP guidelines

Exclusion criteria:

Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of treatment Day 1
Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks
Active brain metastases
Significant or recent acute gastrointestinal disorders with diarrhea
Patients who have any other life-threatening illness or organ system dysfunction,
Other malignancies diagnosed within the past five (5) years
Radiotherapy within the past 2 weeks prior to treatment
History of clinically significant or uncontrolled cardiac disease
Adequate ANC and platelet count
Adequate liver and kidney function
Patients with any serious active infection including known HIV, active hepatitis B or active hepatitis C