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
Phase 3
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080220259
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety/Efficacy Primary Outcomes: To compare gefitinib with carboplatin/paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival. Secondary Outcomes: To compare Iressa v carboplatin/paclitaxel in terms of overall survival; To compare Iressa carboplatin/paclitaxel in terms of objective tumour response rate; To compare the safety and tolerability profile of Iressa v carboplatin/paclitaxel.
- Secondary Outcome Measures
Name Time Method