NSCLC
Conditions
Interventions
Treatment with BIBF1120.
Sponsors
Stichting NVALT studies
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Stage IIIB or IV or recurrent NSCLC haboring a positive FISH for FGFR1 amplification. * Age * 18 years. * Measurable disease * ECOG Performance Status of 0 * 1. * Life expectancy > 3 months.
Exclusion criteria
Exclusion criteria: * Other investigational drugs or treatment in another clinical trial within the past 4 weeks. * Chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks. * Radiotherapy on the target lesions within the last 4 weeks. * Previous therapy with other VEGFR inhibitors or VEGF ligand inhibitors for treatment of NSCLC. * Symptomatic brain metastases or leptomeningeal disease.. * Radiographic evidence of cavitation or necrotic tumors. * Centrally located tumors with radiographic evidence of local invasion of major blood vessels. * History of clinically significant haemoptysis within the past 3 months. * Known inherited predisposition to bleeding or thrombosis. * Pre-existing ascites and/or clinically significant pleural effusion. * 21. Patients who are sexually active and unwilling to use a medically acceptable method of contraception.. * Pregnancy or lactation. i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, duration of response, overall survival and safety | — |
Countries
Netherlands
Outcome results
None listed