A Phase III Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250 mg 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
A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to
Assess the Efficacy and Safety of continuing IRESSA 250 mg 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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression Free Survival (PFS) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to patients with Pemetrexed & Cisplatin alone.
An expected average of 48 weeks after last subject enrolled into our study
No
Haiyi Jiang, M.D. MSc
Study Director
Zhangjiang Hi-tech Park, 3F, Room 3102, 199 Liangjing Road, Pudong Shanghai, postal code:201203
China: Food and Drug Administration
D791LC00001
NCT01544179
March 2012
January 2016
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