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

The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.


Eligibility Criteria:
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;
* 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 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