Despite recent advances in the treatment of NSCLC overall survival within these patients remains dismal and there is yet an unmet medical need for additional treatment options. In this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and bevacizumab) is tested to determine the objective response rate in patients with unresectable and advanced non-small cell lung cancer. This response rate will be compared with historical data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -\> Staging -\> further 3 cycles BCD Q3W -\> Bevacizumab Q3W until progression
3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -\> Staging -\> further 3 cycles BCD Q3W
3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -\> Staging -\> further 3 cycles BCD Q3W
Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III
Salzburg, State of Salzburg, Austria
Univ.-Klinik für Innere Medizin V Innsbruck, Abteilung für Hämatologie und Onkologie
Innsbruck, Tyrol, Austria
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, Austria
Response Rate
The primary objective of this proof-of-concept study is to determine the objective response rate in patients with unresectable, stage IIIB and IV non-small cell lung carcinoma treated with the combination cisplatin, docetaxel and bevacizumab. This response rate will be compared to historical data from the ECOG4599 and AVAiL trials.
Time frame: 4 years
Progression free survival
Progression free survival, defined as the duration of time from first study treatment until progression or death from any cause as documented by the investigator.
Time frame: 5 years
Overall survival
Overall survival, defined as the duration of time from first study treatment until death from any cause.
Time frame: 5 years
Duration of response
Duration of response defined as timeframe from first response (CR or PR) until progression from best response.
Time frame: 5 years
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