ME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer
- Conditions
- Health Condition 1: null- Locally advanced and/or metastatic or recurrent Non Smail Cell Lung Cancer
- Registration Number
- CTRI/2013/02/003343
- Lead Sponsor
- Boehringer IngelheimKorea Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1300
1male or female patient aged 18 years or older
2histologically 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)
3.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)
4.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 ?d 20 mm with conventional techniques or as ?d 10 mm with spiral CT
5.life expectancy of at least three months
6.ECOG score of 0 or 1
7.patient has given written informed consent which must be consistent with international conference on harmonisation ? good clinical practice (ICH-GCP) and local legislation
1)NSCLC
2)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
3)previous therapy with other VEGFR inhibitors (other than bevacizumab) or docetaxel for treatment of NSCLC
4)persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy
5)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
6)chemo-, hormone-, radio-(except for brain and 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
7)radiotherapy (except extremities and brain) within the past three months prior to baseline imaging
8)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
9)radiographic evidence of cavitary or necrotic tumours
10)centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels
11)history of clinically significant haemoptysis within the past 3 months (more than one tea spoon of fresh blood per day)
12)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)
13)history of major thrombotic or clinically relevant major bleeding event in the past 6 months
14)known inherited predisposition to bleeding or thrombosis
15)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)
16)serum creatinine > 1.5 times the upper limit of normal
17)proteinuria CTCAE grade 2 or greater
18)total bilirubin above the upper limit of normal
19)ALT and/or AST > 1.5 x upper limit of normal
20)prothrombin time and/or partial thromboplastin time greater than 50 % deviation from normal limits
21)absolute neutrophil count (ANC) < 1500/mL
22)platelets < 100000/mL
23)haemoglobin < 9.0 g/dL
24)significant weight loss ( > 10 %) within the past 6 weeks prior to treatment in the present trial
25)current peripheral neuropathy CTCAE grade 2 except due to trauma
26)preexisting ascites and/or clinically significant pleural effusion
27)major injuries and/or surgery within the past ten days prior to randomisation with incomplete wound healing
28)serious infections requiring systemic antibiotic (
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression free survivalTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method overall survival, tumour response, quality of life, safety, pharmacokineticsTimepoint: 12 months