Stage IIIB/IV or recurrent non small cell lung cancer. non squamous histology MedDRA version: 14.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version:
Conditions
Interventions
Product Name: BIBF 1120 100 mg capsules
Product Code: BIBF 1120
Pharmaceutical Form: Capsule, soft
Current Sponsor code: BIBF 1120
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =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 the International Conference on Harmonization – 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 520 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 780
Exclusion criteria
Exclusion criteria: - More than one prior chemotherapy regimen for advanced and/or metastatic disease of NSCLC - More than one chemotherapy treatment regimen (either neoadjuvant or adjuvant or neoadjvant plus adjuvant) prior to first line chemotherapy of advanced, metastatic or recurrent NSCLC - Previous therapy with other VEGFR inhibitors (other than bevacizumab) or pemetrexed 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-, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for 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. - Radiotherapy (except extremities and brain) within the past three months prior to baseline imaging - Patients taking NSAIDS with short half lives unable or unwilling to interrupt NSAIDsS for a five day period (2 days before pemetrexed, day of pemetrexed, 2 days after pemetrexed). Patients taking NSAIDS with long half lives must interrupt NSAID for 8 days (5 days before, day of and 2 days after treatment with pemetrexed) - Active brain metastases (e.g. stable for NYHA II, serious cardiac arrhythmia, pericardial effusion) - Calculated creatinine clearance by Cockcroft Gault 2.5 x upper limit of normal in the presence of live metastasis or ALT and/or AST >1.5 x upper limit of normal in patients without liver metastasis. - Prothrombin time and/or partial thromboplastin time greater than 50% deviation from normal limits - Absolute neutrophil count (ANC) 10 %) within the past 6 weeks prior to treatment in the present trial Major injuries and/or surgery within the past ten days prior to randomisation with incomplete wound healing - Current peripheral neuropathy =?CTCAE grade 2 except due to trauma - Preexisting ascites
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120/pemetrexed compared to standard pemetrexed alone. In addition, blood will be collected for pharmacokinetic analysis.;Primary end point(s): Progression free survival (imaging assessed by an independent central review according to the modified RECIST criteria);Main Objective: The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy pemetrexed in patients with Stage IIIB/IV or recurrent NSCLC is more effective compared to placebo in combination with standard therapy pemetrexed. The trial will be limited to non squamous histologies. Changes related to Protocol Amendment 3, dated 08. August 2011: No further recruitment into this trial is permitted. All patients who were on active treatment as of June 18th, 2011 were unblinded and placebo was discontinued for all patients. All patients who decided to continue on their active active treatment based on an observed treatment benefit and after discussion with their treating physician receive either monotherapy with pemetrexed (standard of care treatment) or monotherapy with BIBF 1120 (investigational medicinal product) or combination therapy with pemetrexed + BIBF 1120 in case of an observed treatment benefit. ;Timepoint(s) of evaluation of this end point: Analysis will be performed when 713 centrally confirmed progression events have occured. Changes related to Protocol Amendment 3, dated 08. August 2011: The analysis will be performed once the database for all treated patients (i.e. still blinded patients completed prior to the halt of the trial and patients unblinded after the halt of the trial) is locked. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival (key secondary endpoint) • Tumor response according to the modified RECIST criteria (objective tumor response, disease control, duration of disease control) • Incidence and intensity of adverse events according to the common terminology criteria for adverse events (CTCAE version 3.0) • Clinical improvement • Changes in safety laboratory parameters • Quality of life measured by standardized questionnaires (EQ-5D, EORTC QLQ C-30, EORTC QLQ LC 13) • Pharmacokinetics of BIBF 1120 (and of clinical relevant metabolites, if feasible);Timepoint(s) of evaluation of this end point: Overall survival will be analysed either after about 48 months or when 1151 death events have occured. The other end points will also be analysed at this point in time and already before at the time point of analysis of the primary PFS-endpoint. Changes related to Protocol Amendment 3, dated 08. August 2011: The analysis will be performed once the database for all treated patients (i.e. still blinded patients completed prior to the halt of the trial and patients unblinded after the halt of the trial) is locked. | — |
Countries
Argentina, Australia, Belarus, Brazil, Bulgaria, Canada, Chile, Croatia, Ecuador, European Union, Germany, Hong Kong, Hungary, India, Ireland, Israel, Korea, Republic of, Latvia, Macedonia, the former Yugoslav Republic of, Malaysia, Mexico, Moldova, Republic of, Netherlands, New Zealand, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, South Africa, Sweden, Taiwan, Thailand, Turkey, Ukraine, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed