CTRI/2015/08/006113进行中（未招募）4 期
A randomized trial to evaluate the efficacy & safety of Pemetrexed and Platinum Vs Gefitinib in Non-Small Cell Lung Cancer patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 290
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Provision of informed consent
- •Male or female aged >= 18 Years
- •Histologically or cytologically confirmed non-small cell lung carcinoma with adenocarcinoma histology (including bronchoalveolar).
- •Note: adeno-sqaumous histology is not allowed.
- •Sputum cytology alone is not allowed. Cytological
- •specimens obtained by brushing, washing, or needle
- •aspiration of a defined lesion are acceptable.
- •Locally advanced stage IIIB not amenable to local therapy or stage IV (metastatic) disease.
- •Never smokers or light ex-smokers (defined as having ceased smoking at least 1 years before Day 1 of study treatment and having smoked 10 pack-years or fewer)
- •No prior chemotherapy, biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VGEF) inhibitors) or immunological therapy. Previous adjuvant chemotherapy is permitted if treatment was not platinum-based and was completed more than 6 months before day 1. Palliative radiotherapy to a metastatic site is permitted, but palliative wide field radiotherapy to the lung must be completed at least 4 weeks before day 1 with no persistence of any radiotherapy-related toxicity.
- •Measurable disease according to RECIST criteria with at least one measurable lesion not previously irradiated
- •WHO performance status (PS) of 0 to 2
- •Patients must be willing to complete the EORTC QOL .
排除标准
- •1. Known Severe hypersensitivity to Gefitinib
- •2. Known Severe hypersensitivity to platinum & pemetrexed
- •3. Newly Diagnosed CNS mets
- •4. History of presence of any other malignancy with the exception of basal cell carcinoma
研究者
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