CTRI/2016/08/007149尚未招募未知
A randomized study to compare gefitinib vs chemotherapy with gefitinib in EGFR mutation positive Non-Small cell lung cancer in palliative setting.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 350
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
- •Histologically or cytologically confirmed non-small cell lung carcinoma with EGFR mutation positive for exon 19, 21 or 18
- •Locally advanced stage IIIB not amenable to local therapy (eg. Pleural effusion) or stage IV (metastatic) disease.
- •No prior palliative chemotherapy, or palliative 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 EORTC QOL.
排除标准
- •Known severe hypersensitivity to gefitinib or any of the excipients of this product
- •Known severe hypersensitivity to Platinum, Pemetrexed or any of the excipients of these products
- •Known severe hypersensitivity to pre-medications required for treatment with Platinum / Pemetrexed doublet chemotherapy
- •History or presence of any other malignancy with the exception of basal cell carcinoma or cervical cancer in situ
- •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.
- •Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline
- •Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease ( e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.
- •Adequate organ function, including the following:
- •i)Adequate bone marrow reserve: absolute neutrophil (segmented and bands) counts (ANC) >= 1.5X109/L, Platelets >=100X109/L
- •ii)Hepatic: bilirubin <= 1.5 times the upper limit of normal(xULN), Alanine aminotransferase (ALT) & aspartate aminotransferase (AST) <= 3.0 times the ULN if no demonstrable liver metastases (AST,ALT <= 5 XULN is acceptable if liver has tumor involvement).Serum Creatinine <= 1.5 times the ULN or Creatitne Clearance >= 60 ml/min.
- •Pregnancy or breast feeding
- •Unable to tolerate Platinum / Pemetrexed doublet chemotherapy, as judged by the investigator.
- •Life expectancy of <= 12 weeks
- •Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates
- •Treatment with a non-approved or investigational drug within 30 days before Day of study treatment
- •Involvement in the planning and conduct of the study
- •Previous enrollment or randomization of treatment in the present study
研究者
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