Phase I/II Study of Continuous Treatment With BIBF 1120 Added to Standard Dose of Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Cancer Histology
Run-in Phase I
1. Histologically or cytologically confirmed diagnosis of stage IIIB/IV or recurrent Non
Small Cell Lung Cancer (NSCLC) with squamous cell histology.
2. Measurable disease according to Response Evaluation Criteria in Solid Tumours (
3. Patient Eastern Cooperative Oncology Group (ECOG) score of 0-1.
4. Male or female patients age = 18 years.
5. Life expectancy of at least three (3) months.
6. Written informed consent in accordance with International Conference on Harmonisation
- Good Clinical Practice (ICH-GCP) guidelines.
Phase II - in addition to the above criteria:
7. Radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin /
1. 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
2. Prior treatment with other Vascular Endothelial Growth Factor Receptor (VEGFR)
inhibitors (other than bevacizumab)
3. Any contraindications for treatment with gemcitabine and/or cisplatin.
4. Use of any investigational drug within 4 weeks of entering the 1199.82 study.
5. History of major thrombotic or clinically relevant bleeding event in the past 6
6. Significant cardiovascular diseases (i.e. hypertension not controlled by medication.
7. Surgery within 4 weeks (except tumour biopsy) prior randomisation and incomplete
8. Active brain metastases
9. Radiotherapy (except extremities) within 3 months prior to baseline imaging and
radiotherapy for brain metastasis < 4 weeks prior baseline imaging.
10. Any other current malignancy or malignancy diagnosed within the past five (5) years.