NL-OMON38298已完成2 期
A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared with Docetaxel in 2nd Line Subjects with Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Nonsmall Cell Lung Cancer (MEK114653) - MEK114653
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
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
- 18 至 99（—）
入选标准
- •Males and females >=18 years of age.
- •Histologically/cytologically-confirmed adenocarcinoma Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC with a positive mutational status for the KRAS, NRAS, BRAF, or MEK1 gene.
- •Documented tumor progression after receiving at least one, but not more than one, prior approved platinum-containing chemotherapy regimen for advanced stage/metastatic NSCLC.
- •a. Erlotinib maintenance therapy following first-line treatment with any approved platinum-containing chemotherapy is allowed.
- •b. Pemetrexed maintenance therapy is only allowed following a first-line treatment with cisplatin or carboplatin and pemetrexed.
- •c. Patients who have received any treatment (e.g., erlotinib, chemotherapy, or Investigational Agents) in a second-line setting are not allowed.
- •Measurable disease.
- •ECOG performance status 0-1.
- •Safe contraception for male participants with a partner of childbearing potential or female participants of childbearing potential.
排除标准
- •Other malignancy. See protocol for exceptions.
- •CNS manifestations.
- •Treatment with a BRAF or MEK-inhibitor or docetaxel (monotherapy or combination therapy).
- •Anti-cancer treatment in the past 3 weeks.
- •Prior or current evidence/risk of retinal vein occlusion or central serous retinopathy. See protocol for details.
- •Prior or current increased CVS risk.
- •Known HIV, hepatitis B-C infection.
研究者
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