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Studien: AGMT_NSCLC 1 | 



Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 40
Start: Q1 2010 | Ende: Q4 2011
Status: completed

Phase II Study to Investigate the Treatment of Patients with NSCLC Stage IIIB and IV without the Option of Surgery with a Combination of Cisplatin, Docetaxel and Bevacizumab


This is a non-randomized, multicenter, open-label, single-arm Phase II study in patients with previously untreated inoperable NSCLC stages IIIB and IV.


Primary endpoint
The primary objective of this proof-of-concept study is to determine the objective response rate of patients treated within the study protocoll. This response rate will be compared to historical data from the ECOG4599 and AVAiL trials.
Secondary endpoints
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.
Overall survival; Duration of response; Overall toxicity according to NCI-CTC criteria.

Einschlusskriterien (Auszug)

Histologically or cytologically documented inoperable, locally advanced (Stage IIIB with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (Stage IV) or recurrent NSCLC other than squamous cell (i.e. adenocarcinoma or large-cell carcinoma, tumours of mixed histology should be categorized by the predominant cell type)
At least 1 measurable lesion according to RECIST criteria
No previous neoadjuvant/adjuvant chemotherapy or previous radiotherapy