A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology.

Inclusion criteria

Run-in Phase I

• Histologically or cytologically confirmed diagnosis of stage IIIB/IV or recurrent Non Small Cell Lung Cancer (NSCLC) with squamous cell histology.
• Measurable disease according to Response Evaluation Criteria in Solid Tumours ( RECIST 1.1).
• Patient Eastern Cooperative Oncology Group (ECOG) score of 0-1.
• Male or female patients age = 18 years.
• Life expectancy of at least three (3) months.
• Written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines.

Phase II - in addition to the above criteria:

• Radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin / gemcitabine chemotherapy.

Exclusion criteria

• Prior therapy for advanced or metastatic or recurrent Non Small Cell Lung Cancer (NSCLC). One prior adjuvant, neoadjuvant or adjuvant + neoadjuvant treatment is allowed if at least 12 months have elapsed between the end of the treatment and randomization
• Prior treatment with other Vascular Endothelial Growth Factor Receptor (VEGFR) inhibitors (other than bevacizumab)
• Any contraindications for treatment with gemcitabine and/or cisplatin.
• Use of any investigational drug within 4 weeks of entering the 1199.82 study.
• History of major thrombotic or clinically relevant bleeding event in the past 6 months.
• Significant cardiovascular diseases (i.e. hypertension not controlled by medication.
• Surgery within 4 weeks (except tumour biopsy) prior randomisation and incomplete wound healing.
• Active brain metastases
• Radiotherapy (except extremities) within 3 months prior to baseline imaging and radiotherapy for brain metastasis < 4 weeks prior baseline imaging.
• Any other current malignancy or malignancy diagnosed within the past five (5) years.