Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia
18 Years
N/A
Both
Non-Small Cell Lung Cancer
Trial Information
Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia
Inclusion Criteria:
- Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic)
NSCLC with adenocarcinoma histology.
- Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of
study treatment and 10 pack-years or fewer)
Exclusion Criteria:
- Had prior chemotherapy, biological (including targeted therapies such as EGFR and
vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy.
- Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Median Progression Free Survival (PFS) in Months
Outcome Description:
PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here.
Outcome Time Frame:
Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).
Safety Issue:
No
Principal Investigator
Alison Armour, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Hong Kong: Department of Health
Study ID:
D791AC00007
NCT ID:
NCT00322452
Start Date:
March 2006
Completion Date:
June 2010
Related Keywords:
- Non-Small Cell Lung Cancer
- NSCLC
- Gefitinib
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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