None listed
Conditions
Interventions
Patients in Part A of the study who successfully complete the screening phase will receive an initial dose of 50mg / day of BIBW 2992.
In Part B of the study, patients who meet the inclusion crite
Sponsors
Boehringer Ingelheim,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV who have failed treatment with erlotinib) or gefitinib. 2) Patients should have received and failed at least one line of cytotoxic chemotherapy including a platinum-based regimen in patients eligible for platinum-based therapy and pemetrexed in pemetrexed eligible patients (unless pemetrexed is not considered a regulatory or clinical standard of care e.g. no label indication, no availability or no coverage by 3rd party payer(s)) for advanced or metastatic disease and have progressive disease following at least 12 weeks of treatment with erlotinib or gefitinib. 3) Eastern Cooperative Oncology Group performance Score 0 or 1. 4) 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 10 mm but no less than double the slice thickness according to RESIST 1.1
Exclusion criteria
Exclusion criteria: 1) Previous treatment with BIBW 2992 2) Chemo-, hormone- (other than megestrol acetate, steroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; except for TKI pretreatment (2 weeks only) 3) Active/symptomatic brain metastases including leptomeningeal disease. Patients with a history of treated brain metastasis must have a stable or normal brain MRT/CT scan at screening and be at least 4 weeks post-radiation or surgery for brain metastasis. Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization. 4) Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn´s disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline
Countries
Argentina, Australia, Brazil, China, Finland, France
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed