Phase II, Randomised, Double-blind, Two-arm, Parallel Study of Vandetanib (ZACTIMA™ , ZD6474) Plus Gemcitabine (Gemzar® ) or Gemcitabine Plus Placebo as First Line Treatment of Advanced (Stage IIIB or IV) Non Small Cell Lung Cancer (NSCLC) Elderly Patients.
- Histologic or cytologic confirmation of advanced NSCLC (stage IIIB with
supraclavicular lymph node metastases or pleural effusion or stage IV) on entry into
- One or more measurable lesions at least 10 mm in the longest diameter (LD) by spiral
CT scan or 20 mm with conventional techniques according to RECIST criteria
- Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3
months before the trial entry is accepted).
- Female or male aged 70 years or above
- Patients must not have received prior anti-cancer therapy except in the adjuvant
- Inadequate end-organ function or Evidence of severe or uncontrolled systemic disease
or any concurrent condition which in the Investigator's opinion makes it undesirable
for the patient to participate in the trial
- Significant cardiovascular event (e.g. myocardial infarction, superior vena cava
[SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ³2)
within 3 months before entry, or presence of cardiac disease that in the opinion of
- History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on