JPRN-jRCT1080221763未知2 期
A Randomised Phase 2 Trial of Pemetrexed and Gefitinib Versus Gefitinib as First Line Treatment for Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations
试验速览
- 阶段
- 2 期
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
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Histologically or cytologically confirmed advanced (Stage IV) or recurrent non-squamous NSCLC.
- •-Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- •-The participant's primary NSCLC tumor has an activating Epidermal Growth Factor Receptor (EGFR) mutation, as determined by any validated method.
- •-The participant has measurable disease at the time of study entry.
- •-The participant has not had any prior systemic chemotherapy, immunotherapy, or biological therapy (for example, targeted therapy, such as erlotinib or gefitinib) for Stage IV or recurrent non-squamous NSCLC.
- •-The participant has adequate organ function(hematopoietic function, liver function, renal function).
- •-The participant is able to take folic acid, vitamin B12, and dexamethasone, according to the protocol's requirements.
- •-Prior radiation therapy is allowed to <25% of the bone marrow.
排除标准
- •-The participant is receiving concurrent treatment with any other anticancer therapy.
- •-The participant has untreated central nervous system (CNS) metastases.
- •-The participant has a serious illness or medical condition that would compromise their safety or impair their ability to comply with the protocol's requirements.
- •-Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose equal to or less than 1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed.
- •-Concomitant use of cytochrome P450 (CYP)3A4 inducers or CYP3A4 inhibitors.
- •-Any known significant ophthalmologic abnormalities of the surface of the eye. The use of contact lenses is not recommended during the study.
- •-The participant has previously received treatment with gefitinib, erlotinib or pemetrexed.
- •-Any evidence of clinically active interstitial lung disease.
- •-The participant is pregnant or breastfeeding.
研究者
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