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
Inclusion 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;
- 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