A phase III, Randomized, Double-Blind, Multi-Centre Parallel-Group Study to Assess the Efficacy of ZD6474 (ZACTIMA) Versus Erlotinib (TARCEVA ) in Patients with Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) after failure of at least One Prior Cytotoxic Chemoterapy
- Conditions
- ocally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2006-000259-16-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 1150
1.Provision of informed consent
2.Female or male aged 18 years and ove
3.Histologic or cytologic confirmation of locally advanced or metastatic NSCLC(IIIB-IV). Sputum cytology alone is not acceptable. Cytology specimens obtained by brushing, washing, or needle aspiration are acceptable.
4.Failure of at least one, but no more than two, prior cytotoxic chemotherapy regimens (either radiological documentation of disease progression or due to toxicity).
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.Negative pregnancy test for women of childbearing potential
8.Life expectancy of 12 weeks or longer.
9.Able to read and write
For inclusion in the genetic research part of the study, patients must fulfil the following criterion:
10. Provision of informed consent for genetic research and tissue sampling
If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
1.Mixed small cell and non small-cell lung cancer histology
2.Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab[Erbitux] or bevacizumab [Avastin] is permitted)
3.Chemotherapy or other systemic anti-cancer therapy within 4 weeks before the startof study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
4.Radiation therapy within 4 weeks before the start of study therapy, not includinglocal palliative radiation. Lesions that have received radiation in the advancedsetting cannot be included as target lesions unless clear tumour progression hasbeen documented in the lesions since the end of radiation therapy
5.Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy
6.Any unresolved toxicity > CTCAE grade 2 from previous anti-cancer therapy
7.Serum bilirubin greater than 1.5x upper limit of reference range (ULRR)
8.Serum creatinine greater than 1.5 x ULRR or creatinine clearance ≤50 ml/min (calculated by Cockcroft-Gault formula)
9.ALT or AST > 2.5 x ULRR if no demonstrable liver metastases, or > 5 x ULRR if judged by the Investigator to be related to liver metastases
10.Alkaline phosphatase (ALP) > 2.5 x ULRR if no demonstrable liver metastases, or 5 x ULRR if judged by the Investigator to be related to liver metastases
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method