Multicentre, randomised, double-blind, Phase III trial to investigate theefficacy and safety of oral BIBF 1120 plus standard docetaxel therapycompared to placebo plus standard docetaxel therapy in patients withstage IIIB/IV or recurrent non small cell lung cancer after failure of firstline chemotherapy.Estudio en Fase III, multicéntrico, randomizado, doble-ciego, para investigar la eficacia y seguridad de la administración oral de BIBF 1120 junto con Docetaxel como terapia estándar comparado con placebo junto con Docetaxel como terapia estándar en pacientes con cáncer de pulmón no microcítico en estadío IIIB/IV o recurrente después del fracaso de la quimioterapia de primera línea. - BIBF 1120 plus docetaxel in 2nd line NSCLC
- Conditions
- stage IIIB/IV or recurrent non small cell lung cancer after failure of firstline chemotherapyCáncer de pulmón no microcítico en estadío IIIB/IV o recurrente después del fracaso de la quimioterapia de primera líneaMedDRA version: 9.1Level: LLTClassification code 10066490Term: Progression of non small cell lung cancer
- Registration Number
- EUCTR2007-004803-36-ES
- Lead Sponsor
- Boehringer Ingelheim International GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1300
• 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
more than one prior chemotherapy regimen for advanced and/or metastatic disease or recurrent NSCLC
more than one chemotherapy treatment regimen 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 or anti-cancer drugs 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
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 disease
inadequate safety laboratory parameters
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 illness, active infections requiring systemic antimicrobial therapy or concomitant non-oncological disease
patients unwilling to use a medically acceptable contraception
pregnancy or breast feeding
psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol
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 hypersensitivity to docetaxel, polysorbate 80 (Tween 80), BIBF 1120, contrast media
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.<br><br>primary endpoint: progression free survival;Secondary Objective: overall survival (key secondary endpoint)<br>tumour response according to the modified RECIST criteria (objective tumour response, disease control, duration of disease control)<br>incidence and intensity of adverse events according to the common terminology criteria for adverse events (CTCAE version 3.0)<br>clinical improvement<br>changes in safety laboratory parameters<br>quality of life measured by standardized questionnaires (EQ-5D, EORTC QLQ-C-30,<br>EORTC QLQ-LC-13)<br>pharmacokinetics of BIBF 1120 (and of clinical relevant metabolites, if feasible);Primary end point(s): progression free survival
- Secondary Outcome Measures
Name Time Method