A Phase III, Randomized, Double-Blinded, Multi-Center Study to Assess the Efficacy of Docetaxel TAXOTERE in Combination with ZD6474 ZACTIMA versus Docetaxel TAXOTERE in combination with Placebo in Patients With Locally Advanced or Metastatic Stage IIIb IV Non-small Cell Lung Cancer NSCLC after Failure of 1st Line Anti-Cancer Therapy - ND

Conditions: on small cell lung cancer NSCLC
MedDRA version: 6.1Level: PTClassification code 10061873

Registration Number: EUCTR2005-004749-32-IT

Lead Sponsor: ASTRAZENECA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1240

Inclusion Criteria

1. Provision of informed consent 2. Female or male aged 18 years and over 3. Histologic or cytologic confirmation of locally advanced or metastatic NSCLC IIIb-IV on entry into study 4. Failure of 1st line anti-cancer therapy either radiological documentation of disease progression or due to toxicity or subsequent relapse of disease following 1st line therapy 5. WHO PS 0 1 6. 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 7. Negative pregnancy test for women of childbearing potential 8. Life expectancy of 12 weeks or longer
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Mixed small cell and non-small cell lung cancer histology 2.Subjects who have received 2nd-line anti-cancer therapy 3.Prior treatment with docetaxel prior treatment with paclitaxel is acceptable 4.Prior treatment with VEGFR TKIs previous treatment with bevacizumab Avastin is permitted 5.The last dose of prior chemotherapy or other anti-cancer therapy is discontinued less than 4 weeks before the start of study therapy 6 weeks for nitrosoureas, mitomycin, and suramin 6.The last radiation therapy within 4 weeks before the start of study therapy, not including local palliative radiation 7.Any unresolved toxicity CTCAE grade 2 from previous anti-cancer therapy 8.History of arrhythmia multifocal premature ventricular contractions PVCs , bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation which is symptomatic or requires treatment CTCAE grade 3 or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded. 9.Presence of left bundle branch block LBBB 10.QTc with Bazett s correction unmeasurable or 8805;480 msec on screening ECG Note If a subject has QTc interval 8805;480 msec on screening ECG, the screen ECG may be repeated twice at least 24 hours apart . The average QTc from the three screening ECGs must be 480 msec in order for the subject to be eligible for the study. 11.Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable without steroid treatment for 10 days