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 - Zelig

Conditions: Advanced (stage IIIB or IV) Non Small Cell Lung Cancer (NSCLC)
MedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIB

Registration Number: EUCTR2007-004521-22-IT

Lead Sponsor: ASTRAZENECA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Provision of informed consent
2.Female or male aged 70 years or above
3.Histologic or cytologic confirmation of advanced NSCLC (stage IIIB with supraclavicular lymph node metastases or pleural effusion or stage IV) on entry into study
4.No prior anti-cancer therapies except in the adjuvant setting
5.WHO Performance status 0 - 2
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.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) no
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.Patients have received prior anti-cancer therapy except in the adjuvant setting
3.Prior treatment with gemcitabine
4.Prior treatment with VEGFR TKIs (previous treatment with bevacizumab [Avastin] in the adjuvant setting is permitted)
5.Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable without steroid treatment for 10 days
6.The last radiation therapy within 4 weeks before the start of study therapy, not including local palliative radiation
7.The last dose of prior chemotherapy or other anti-cancer therapy is discontinued less than 3 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin, and suramin)
8.Major surgery within 4 weeks before entry, or incompletely healed surgical incision

Others are specificied in the protocol