Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC

Exclusion Criteria

• •1. Previous therapy with other vascular endothelial growth factor (VEGF) inhibitors (other than bevacizumab) or pemetrexed for treatment of NSCLC
• •2. 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
• •3. 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
• •4. Inability to stop intake of NSAIDS (non steroidal anti inflammatory drugs) for several days
• •5. 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)
• •6. Radiographic evidence of cavitary or necrotic tumors
• •7. Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
• •8. History of clinically significant haemoptysis within the past 3 months
• •9. Therapeutic anticoagulation
• •10. History of major thrombotic or clinically relevant major bleeding event in the past 6 months
• •11. Significant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months,
• •12. Inadequate kidney, liver, blood clotting function
• •13. Inadequate blood count
• •14. 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 Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except due to trauma
• •16. Pre-existing ascites (abdominal fluid collection) and/or clinically significant pleural effusion ( fluid collection between the lung and chest wall)
• •17. Major injuries and/or surgery within the past ten days prior to start of study drug
• •18. Incomplete wound healing