LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer

Inclusion criteria:

• male or female patient aged 18 years or older;

• histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC ofstage IIIB or IV or recurrent NSCLC;

• relapse or failure of one first line prior chemotherapy;

• at least one target tumour lesion that has not been irradiated within the past threemonths and that can accurately be measured ;

• life expectancy of at least three months;

• Eastern Cooperative Oncology group (ECOG) score of 0 or 1;

• patient has given written informed consent

Exclusion criteria:

• more than one prior chemotherapy regimen for advanced and/or metastatic or recurrentNSCLC;

• more than one chemotherapy treatment regimen (either neoadjuvant or adjuvant orneoadjuvant plus adjuvant) prior to first line chemotherapy;

• previous therapy with other VEGFR inhibitors (other than bevacizumab) or docetaxel fortreatment of NSCLC;

• persistence of clinically relevant therapy related toxicities from previouschemotherapy and/or radiotherapy;

• treatment with other investigational drugs or other anti-cancer therapy or treatmentin another clinical trial within the past four weeks before start of - therapy orconcomitantly with this trial ;

• radiotherapy (except extremities and brain) within the past three months prior tobaseline imaging;

• active brain metastases or leptomeningeal disease;

• radiographic evidence of cavitary or necrotic tumours;

• centrally located tumours with radiographic evidence (CT or MRI) of local invasion ofmajor blood vessels;

• history of clinically significant haemoptysis within the past 3 months;

• therapeutic anticoagulation (except low dose heparin) or antiplatelet therapy;

• history of major thrombotic or clinically relevant major bleeding event in the past 6months;

• known inherited predisposition to bleeding or thrombosis;

• significant cardiovascular diseases ;

• inadequate safety laboratory parameters;

• significant weight loss (> 10 %) within the past 6 weeks;

• current peripheral neuropathy greater than CTCAE grade 2 except due to trauma;

• preexisting ascites and/or clinically significant pleural effusion;

• major injuries and/or surgery within the past ten days prior to randomisation withincomplete wound healing;

• serious infections requiring systemic antibiotic therapy;

• decompensated diabetes mellitus or other contraindication to high dose corticosteroidtherapy;

• gastrointestinal disorders or abnormalities that would interfere with absorption ofthe study drug;

• active or chronic hepatitis C and/or B infection;

• serious illness or concomitant non-oncological disease or laboratory abnormality thatmay increase the risk associated with study participation or study drugadministration;

• patients who are sexually active and unwilling to use a medically acceptable method ofcontraception during the trial and for at least twelve months after end of activetherapy;

• pregnancy or breast feeding;

• psychological, familial, sociological or geographical factors potentially hamperingcompliance with the study protocol and follow-up schedule;

• patients unable to comply with the protocol;

• active alcohol or drug abuse;

• other malignancy within the past three years other than basal cell skin cancer, orcarcinoma in situ of the cervix;

• any contraindications for therapy with docetaxel;

• history of severe hypersensitivity reactions to docetaxel or other drugs formulatedwith polysorbate 80 (Tween 80);

• hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs;

• hypersensitivity to contrast media