A Phase III, Randomized, Double-blinded, Parallel Group, Multi-centre Study to Assess the Efficacy and Safety of ZD6474 ZACTIMA in Combination with Pemetrexed Alimta versus Pemetrexed alone in Patients with Locally-Advanced or Metastatic stage IIIB or IV Non-Small Cell Lung Cancer NSCLC after Failure of 1st Line Anti-cancer Therapy - ZACTIMA 36

• Conditions: ocally-Advanced or Metastatic stage IIIB or IV Non-Small Cell Lung Cancer NSCLC; MedDRA version: 6.1Level: PTClassification code 10061873

• Registration Number: EUCTR2006-003695-35-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-14
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 418

Inclusion Criteria

Provision of informed consent Female or male aged 18 years or above Histologic or cytologic confirmation of locally advanced or metastatic NSCLC stage IIIB or IV on entry into study 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 WHO Performance status 0 - 2 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 Life expectancy of 12 weeks or longer Negative pregnancy test for women of childbearing potential only
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. Patients have received 2nd-line or subsequent anti-cancer therapy 3. Prior treatment with pemetrexed 4. Prior treatment with VEGFR TKIs previous treatment with bevacizumab Avastin 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 9. Neutrophils 1.5 x 109/L or platelets 100 x 109/L 10. Serum bilirubin 1.5 x the upper limit of reference range ULRR

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified