BIBF 1120 plus pemetrexed compared to placebo plus pemetrexed in 2nd line nonsquamous NSCLC

Not Applicable

Conditions: -C349 Bronchus or lung, unspecified
Bronchus or lung, unspecified
C349

Registration Number: PER-003-09

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI),

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 34

Inclusion Criteria

• Male or female patients 18 years of age or older
• Histologically or cytologically confirmed NSCLC, stage IIIB / IV (according to AJCC) or recurrent (non-epidermoid histologies)
• Relapse or failure of a first-line chemotherapy (in the case of recurrent disease, an additional prior regimen is allowed as an adjuvant, neoadjuvant or neoadjuvant therapy together with adjuvant therapy)
• At least one white tumor lesion that has not been irradiated within the last three months and that can be accurately measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (the maximum diameter should be recorded) that either> 20 mm with conventional techniques or> 10 mm with helical CT
• Life expectancy of at least three months
• ECOG score 0 or 1
• The patient must provide written informed consent, which must be consistent with the Good Clinical Practice of the International Conference on Harmonization (ICH-GCP) and local legislation

Exclusion Criteria

• Previous therapy with other vascular endothelial growth factor (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 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
• Current peripheral neuropathy greater than or equal to Common Terminology Criteria for Adverse Events (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 Additional exclusion criteria apply

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).<br><br>Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.<br><br><br><br>Measure:Progression Free Survival (PFS) as Assessed by Central Independent Review<br>Timepoints:From randomisation until cut-off date 9 July 2012<br>

Secondary Outcome Measures

Name	Time	Method

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