BIBF 1120 in Combination With Pemetrexed in Advanced Non Small Cell Lung Cancer (NSCLC)

Exclusion Criteria

• •1. Patients who have received treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial or who have not recovered from side effects of such therapy (except for alopecia)
• •2. Patients who have received chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug or who have not recovered from side effects of such therapy (except for alopecia) .
• •3. Patients who have received radiotherapy within the following period Phase I part: the past 4 weeks prior to treatment with the trial drug (in case of palliative radiotherapy such as for extremities, within the past 2 weeks prior to treatment with the trial drug)
• •4. Previous therapy with other vascular endothelial growth factor receptor (VEGFR) inhibitors or vascular endothelial growth factor (VEGF) ligand inhibitors for treatment of NSCLC
• •5. Previous therapy with BIBF 1120 and/or pemetrexed for treatment of NSCLC and any contraindications for therapy with pemetrexed
• •6. Patients who have active brain metastases
• •7. Leptomeningeal disease
• •8. Patients with distinct or suspected pulmonary fibrosis or interstitial lung disease by the CT findings, or patients with a previous history of pulmonary fibrosis or interstitial lung disease (except irradiation-pneumonitis appearing radiation field with past radiotherapy).
• •9. Radiographic evidence of cavitary or necrotic tumors
• •10. Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
• •11. History of clinically significant haemoptysis within the past 3 months
• •12. History of major thrombotic or clinically relevant major bleeding event in the past 6 months
• •13. Known inherited predisposition to bleeding or thrombosis
• •14. Significant cardiovascular diseases
• •15. Significant weight loss (\>10%) within the past 6 weeks prior to treatment in the present trial
• •16. Current peripheral neuropathy CTCAE grade 2 or greater except due to trauma
• •17. Pre-existing ascites and/or clinically significant pleural effusion
• •18. Major injuries and/or surgery within the past 4 weeks prior to randomisation with incomplete wound healing
• •19. Clinically serious infections
• •20. Decompensated diabetes mellitus
• •21. Contraindication to high dose steroid therapy
• •22. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
• •23. Patients who have active or chronic hepatitis C and/or B infection and diagnosis of human immunodeficiency virus (HIV) infection
• •24. Other malignancy other than basal cell skin cancer, carcinoma in situ or intra-mucosal cancer that were judged to be cured by adequate treatment and disease-free interval is more than 5 years
• •25. History of serious drug hypersensitivity
• •26. Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation
• •27. Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy
• •28. Patients who are sexually active and unwilling to use a medically acceptable method of contraception
• •29. Pregnancy or breast feeding
• •30. Active alcohol or drug abuse
• •31. Patients unable to comply with the protocol
• •32. Other patients judged ineligible for enrolment in the study by the investigator or subinvestigator.