Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)

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

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.

Inclusion Criteria:

• Histologically or cytologically documented inoperable, locally advanced, metastatic or recurrent NSCLC other than squamous cell
• At least 1 measurable lesion according to RECIST criteria
• ECOG performance score 0 or 1
• Age between 18 and 70 years

Exclusion Criteria:

• Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.
• History of haemoptysis
• Evidence of tumour invading major blood vessels on imaging.
• Previous neoadjuvant/adjuvant chemotherapy.
• Previous radiotherapy.
• Serious uncontrolled coagulation disorder or thrombo-embolic complications within 6 months prior to study start or history of serious bleeding complications.
• Major surgical procedures within 4 weeks prior to study entry.
• Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
• Non-healing wound, active peptic ulcer or bone fracture.
• History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.