ME-Lung 1: BIBF 1120 plus docetaxel as compared to placebo plus docetaxel in 2nd line non small cell lung cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1300

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 (according to American Joint Committee on Cancers) or recurrent NSCLC (all histologies)
• relapse or failure of one first line prior chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy)
• at least one target tumour lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques or as = 10 mm with spiral CT
• life expectancy of at least three months
• ECOG score of 0 or 1
• patient has given written informed consent which must be consistent with international conference on harmonisation – good clinical practice (ICH-GCP) and local legislation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

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 neoadjvant plus adjuvant) prior to first line chemotherapy of advanced and/or metastatic or recurrent NSCLC
• 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 treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
• chemo-, hormone-, radio-(except for extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past four weeks prior to treatment with the trial drug. I.e. the minimum time elapsed since the last anticancer therapy and the first administration of BIBF 1120 must be four weeks
• radiotherapy (except extremities and brain) within the past three months prior to baseline imaging
• active brain metastases (e.g. stable for < 4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation) 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 (more than one tea spoon of fresh blood per day)
• therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid = 325mg per day)
• 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 (i.e. hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion)
• serum creatinine > 1.5 times the upper limit of normal
• proteinuria CTCAE grade 2 or greater
• total bilirubin above the upper limit of normal
• ALT and/or AST > 1.5 x upper limit of normal
• prothrombin time and/or partial thromboplastin time greater than 50 % deviation from normal limits
• absolute neutrophil count (ANC) < 1500/microL (= mm3)
• platelets < 100000/ microL (= mm3)
• haemoglobin < 9.0 g/dL
• significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial
• current peripheral neuropathy = 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 (e.g antiviral, antimicrobial, antifungal)
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 illnes

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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