BIBF 1120 plus docetaxel in patients with non small cell lung cancer
Multicentre, randomised, double-blind, Phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard docetaxel therapy compared to placebo plus standard docetaxel therapy in patients with stage IIIB/IV or recurrent non small cell lung cancer after failure of first line chemotherapy
Boehringer Ingelheim Pharma GmbH & Co. KG
Patients with locally advanced and/or metastatic or recurrent Non Small Cell Lung Cancer (NSCLC) who failed one previous treatment with chemotherapy may join this trial. Every growing tumour such as non small cell lung cancer needs sufficient blood supply by the formation of new blood vessels. BIBF 1120 is a new investigational drug that blocks the formation of new blood vessels. It is administered orally. Clinical phase I-II data revealed an acceptable safety profile and first promising signs of efficacy in different types of tumours. In this study half of the patients will get BIBF 1120 and the other half placebo (an inactive drug, sometimes called a sugar pill). Neither the patient nor the physician will know which patient has been randomly assigned to placebo or BIBF 1120 (known as double blind). All patients will be treated with docetaxel, which besides pemetrexed or erlotinib is the approved standard chemotherapy for this stage of NSCLC. The aim of the trial is to investigate whether this new combination treatment reduces tumour growth, prolongs survival and shows an acceptable safety profile. They should visit their investigator regularly for determination of e.g. safety laboratory parameters. Tumour response will be measured every six weeks. Patients may continue therapy until tumour progression, occurrence of intolerable side effects or until they want to stop the treatment for any reason. After end of active treatment, patients will be followed up.The trial is sponsored by Boehringer Ingelheim and will be performed according to ICH-GCP guidelines. It has been approved by the regulatory authorities and ethics committees. The trial will be performed in Asia, Africa and Europe with experienced NSCLC physicians.
West Midlands - Black Country Research Ethics Committee
Date of REC Opinion
7 Jan 2009
Further Information Favourable Opinion