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 of stage 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 three months and that can accurately be measured ;
• life expectancy of at least three months;
• 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 recurrent NSCLC;
• more than one chemotherapy treatment regimen (either neoadjuvant or adjuvant or neoadjuvant plus adjuvant) prior to first line chemotherapy;
• previous therapy with other VEGFR inhibitors (other than bevacizumab) or docetaxel for treatment of NSCLC;
• persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy;
• treatment with other investigational drugs or other anti-cancer therapy or treatment in another clinical trial within the past four weeks before start of - therapy or concomitantly with this trial ;
• radiotherapy (except extremities and brain) within the past three months prior to baseline 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 of major 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 6 months;
• 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 with incomplete wound healing;
• serious infections requiring systemic antibiotic therapy;
• decompensated diabetes mellitus or other contraindication to high dose corticosteroid therapy;
• gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug;
• active or chronic hepatitis C and/or B infection;
• serious illness or concomitant non-oncological disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration;
• patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for at least twelve months after end of active therapy;
• pregnancy or breast feeding;
• psychological, familial, sociological or geographical factors potentially hampering compliance 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, or carcinoma in situ of the cervix;
• any contraindications for therapy with docetaxel;
• history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80);
• hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs;
• hypersensitivity to contrast media