NL-OMON55921已完成3 期
A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK-positive), stage IIIB or IV, non-squamous non-small cell lung cancer - ASCEND-4: LDK378 vs chemo in untreated patients with ALK+ lung cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 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 64（—）
入选标准
- •- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC
- •that is ALK positive
- •- Newly diagnosed stage IIIB or IV NSCLC or relapsed locally advanced or
- •metastatic NSCLC not previously treated with any systemic anti-cancer therapy
- •- At least one measurable lesion as defined by RECIST 1.1.
- •- 18 years of age or older
- •- Life expectancy >= 12 weeks
- •- WHO performance status 0-2.
排除标准
- •- Patient is currently receiving treatment with coumarin-derivative
- •anticoagulants.
- •- Patient with symptomatic CNS metastases.
- •- Patient has history of interstitial lung disease or interstitial pneumonitis
- •- Patient has received thoracic radiotherapy to lung fields <= 4 weeks prior to
- •starting the study treatment. For all other anatomic sites radiotherapy <= 2
- •weeks prior to starting the study treatment or has not recovered from
- •radiotherapy-related toxicities.
- •- Patient has had major surgery within 4 weeks prior (2 weeks for resection of
- •brain metastases) to starting study treatment or has not recovered from side
- •effects of such procedure.
- •- Patient with a concurrent malignancy or history of a malignant disease other
- •than NSCLC that has been diagnosed and/or required therapy within the past 3
- •- Patient has clinically significant, uncontrolled heart disease and/or recent
- •cardiac event (within 6 months)
- •- Patient is pregnant or nursing (lactating) woman
研究者
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