A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of continuing IRESSATM 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 IRESSATM. - IMPRESS

AstraZeneca AB0 个研究点目标入组 250 人2011年12月23日

概览

暂无简介。

注册库

who.int

开始日期

2011年12月23日

结束日期

待定

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

发起方

•1\)\-Male or female patients aged 18 years or older (For Japan only\- male or female patients aged 20 years or older)
•2\)\-Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally
•3\)\-Patients with documented 'acquired resistance? on first line gefitinib
•4\)\-Patients suitable to start cisplatin based pemetrexed combination chemotherapy.
•5\)\-Provision of informed consent prior to any study specific procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 125
•F.1\.3 Elderly (\>\=65 years) yes

•1\)\-Prior chemotherapy or other systemic anti\-cancer treatment (excluding gefitinib).
•2\)\-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
•3\)\-Other co\-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intramucosal gastric cancer
•4\)\-Any evidence of severe of uncontrolled systemic disease
•5\)\-Treatment with an investigational drug within 4 weeks before randomization