A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status
Phase 2/Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
NSCLC
Both
NSCLC
Trial Information
A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status
Inclusion Criteria:
- Histologically or cytologically confirmed NSCLC
- NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable
to curative surgery or radiotherapy
- Not suitable for chemotherapy
- WHO Performance status 2 or 3
Exclusion Criteria:
- Newly diagnosed CNS mets
- Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy
related toxicity
- Other co-existing malignancies
- ALT/AST greater than 5 x upper limit of normal
- ANC less than 1.0 x 109/L or platelets less than 100 x 109/L
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
To compare Iressa v best supportive care in terms of progression free survival
Principal Investigator
AstraZeneca Iressa Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Canada: Health Canada
Study ID:
1839IL/0711
NCT ID:
NCT00259064
Start Date:
September 2004
Completion Date:
June 2013
Related Keywords:
- NSCLC
- Carcinoma, Non-Small-Cell Lung
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