The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed will be obtained.
A Randomized Double-blind Multicenter Phase III Trial of BIBF 1120 Plus Pemetrexed vs. Pemetrexed/ Placebo in Advanced or Recurrent Non Small Cell Lung Cancer Patients After Failure of First Line Therapy
- Non-small-cell lung cancer
Treatment, Parallel Assignment, Safety/Efficacy Study
Primary outcome measures
- Progression free survival
[ Time Frame: October 2010 ]
Secondary outcome measures
- Overall survival tumor response according to modified RECIST criteria incidence and intensity of adverse events clinical improvement changes in safety laboratory parameters quality of life measurement pharmacokinetics of BIBF 1120
[ Time Frame: November 2012 ]
December 2008 – February 2013
Eligibility & Criteria
- Ages eligible for study: 18 years and older
- Genders eligible for study: Both
- Accepts healthy volunteers: No
- Male or female patient aged 18 years or older.
- Histologically or cytologically confirmed Stage IIIB, IV (according to AJCC) or recurrent NSCLC (non squamous histologies)
- Relapse or failure of one first line 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 tumor 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 greater than or equal to 20 mm with conventional techniques or as greater than or equal to 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 the International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local legislation.
- Previous therapy with other VEGF inhibitors (other than bevacizumab) or pemetrexed for treatment of NSCLC
- 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
- Chemotherapy, hormone therapy, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for treatment of brain and extremities) 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
- Inability to stop intake of NSAIDS (non steroidal anti inflammatory drugs) for several days
- 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)
- Radiographic evidence of cavitary or necrotic tumors
- Centrally located tumors 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
- History of major thrombotic or clinically relevant major bleeding event in the past 6 months
- Significant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months,
- Inadequate kidney, liver, blood clotting function
- Inadequate blood count
- Significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial 15 Current peripheral neuropathy greater than or equal to CTCAE Grade 2 except due to trauma
- Pre-existing ascites (abdominal fluid collection) and/or clinically significant pleural effusion ( fluid collection between the lung and chest wall)
- Major injuries and/or surgery within the past ten days prior to start of study drug
- Incomplete wound healing
- Active or chronic hepatitis C and/or B infection
Boehringer Ingelheim Study Coordinator