JPRN-UMIN000017906Enrolling By Invitation2 期
A phase II, multicenter, single-arm study of Induction therapy with LDK378 followed by surgery in patients with ALK fusion-positive Stage II/III non-small cell lung cancer.
ational Cancer Center HospitalEast0 个研究点目标入组 19 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 19
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Histologically or cytologically confirmed diagnosis of NSCLC.
- •2)ALK fusion gene is determined to be positive by at least 2 of the following methods: FISH, immunohistochemical (IHC) examination, and RT-PCR .
- •3)Clinical stage is II or III
- •4)It is considered that complete tumor removal can be achieved by pneumonectomy (lobectomy or more extensive surgical resection) and by lymph node dissection.
- •5)Predicted residual FEV1 after resection is >= 800 ml.
- •6)No previous treatment.
- •7) Male or female aged 20 years and over.
- •8)Performance status (ECOG) is 0 or 1.
- •9) At least one measurable lesion as defined by RECIST (Response Evaluation Criteria in Solid Tumor) ver1.1.
- •10)The following laboratory values indicative of adequate organ functions are available within 7 days before registration:
- •a. Neutrophil count >= 1,500/mm3
- •b. Platelet count >= 100,000/mm3
- •c. Hemoglobin (Hgb) >= 10.0 g/dL
- •d. Serum albumin >= 3.0 g/dL
- •e. Creatinine clearance >= 30 mL/min
- •f. Total bilirubin <= 1.5 mg/dL (total bilirubin <= 3.0 mg/dL in patients with Gilbert's syndrome)
- •g. AST (SGOT) <= 100 IU/L
- •h. ALT (SGPT) <= 100 IU/L
- •i. ALP <= 1800 IU/L
- •j. Amylase <= 300 U/L
- •k. Lipase <= 57U/L
- •l. Fasting plasma glucose <= 175 mg/dL ( <= 9.8 nmol/L)
- •m. Potassium <= 5.0 mEq/L
- •n. Magnesium <= 10.0 mg/dL
- •o. Phosphorus <= 4.5 mg/dL
- •p. Calcium <= 10.0 mg/dL
- •q. SpO2 >= 93%
- •11)Women of child-bearing-potential show a negative result of pregnancy test conducted within 7 days before registration. Both male and female patients agree to use an appropriate method of contraception during the study and for 3 months after discontinuation of the study drug.
- •12)Patients expected to survive for at least 3 months after the first day of preoperative chemotherapy.
- •13)Patients intended and able to comply with scheduled study visit, treatment plan, laboratory tests, and other study-related procedures.
排除标准
- •1) Patient with lymph node metastasis in the neck/ lymph node metastasis in the supraclavicular/ contralateral hilus and contralateral mediastinum.
- •2) Patient having previously experienced hypersensitivity to any additive of LDK378.
- •3) Patient with a history of or currently having malignant tumors other than NSCLC.
- •4) Patient with a history of interstitial lung disease or interstitial pneumonia.
- •5) Patient with any of the following clinically significant and poorly controlled heart diseases:
- •-Unstable angina pectoris and Myocardial infarction within 6 months before registration
- •-A history of congestive heart failure
- •-Poorly controlled hypertension defined as systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg
- •-Arrhythmia not controlled with drugs
- •-QT interval > 470 msec on ECG
- •6) Patient with poorly controlled diabetes mellitus.
- •7) Patient receiving any of the following drugs and in whom it is impossible to discontinue them for at least 1 week before the start of treatment with LDK378:
- •-Potent CYP3A4/5 inhibitor or inducer
- •-Drugs with a small therapeutic index that are mainly metabolized by CYP3A4/5, CYP2C8 or CYP2C9
- •-Drugs known to prolong QT interval or induce Torsades de pointes
- •8) Patient receiving warfarin sodium or other coumarin anticoagulants.
- •9) Patient treated with corticosteroids at unstable doses.
- •10) Patient receiving enzyme-inducing anticonvulsants and in whom it is impossible to discontinue them for at least 1 week before the first administration of LDK378.
- •11) Pregnant women or breast-feeding women.
- •12) Patients with any major acute or chronic medical or mental condition or laboratory abnormality that is considered to increase the risk associated with participation in the study by the investigator.
- •14) Functional gastrointestinal tract disorder/ gastrointestinal disease that significantly prevents absorption of LDK378.
- •15) Patient has a history of pancreatitis/ increased amylase or lipase that was due to pancreatic disease.
研究者
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