A Phase 3 Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250mg in Addition to Chemotherapy Versus Chemotherapy Alone in Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Have Progressed on First Line IRESSA
Phase 3
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT1080221863
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Male or female patients aged 18 years or older (For Japan only- male or female patients aged 20 years or older)
- Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally
- Patients suitable to start chemotherapy.
Exclusion Criteria
- Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib).
- Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method