EUCTR2011-004942-16-HU
进行中（未招募）
1 期
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
适应症on Small Cell Lung CancerMedDRA version: 14.1Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
相关药物IRESSA
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- on Small Cell Lung Cancer
- 发起方
- AstraZeneca AB
- 入组人数
- 265
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
未指定
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