A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI),0 sites7 target enrollmentDecember 17, 2009

Overview

No summary available.

Registry

who.int

Start Date

December 17, 2009

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI),

•Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
•EGFR mutation detected by central laboratory analysis of tumour biopsy material.
•Measurable disease according to RECIST 1\.1\.
•Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\.
•Age \= 18 years.
•Life expectancy of at least three (3\) months.
•Written informed consent that is consistent with ICH\-GCP guidelines.

•Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
•Prior treatment with EGFR targeting small molecules or antibodies.
•Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
•Active brain metastases (defined as stable for \<4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids and/or leptomeningeal disease).
•Any other current malignancy or malignancy diagnosed within the past five (5\) years (other than non\-melanomatous skin cancer and in situ cervical cancer).
•Known pre\-existing interstitial lung disease.
•Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn´s disease, malabsorption or CTC grade \=2 diarrhoea of any aetiology.
•History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation.
•Cardiac left ventricular function with resting ejection fraction of less than 50%.
•Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.

Not specified