PER-064-14尚未招募未知
RANDOMIZED, MULTICENTER, PHASE III,OPEN-LABEL STUDY OF ALECTINIB VERSUSCRIZOTINIB IN TREATMENT-NAÏVE ANAPLASTICLYMPHOMA KINASE−POSITIVE ADVANCEDNON−SMALL CELL LUNG CANCER
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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 80（—）
入选标准
- •Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not
- •amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive
- •as assessed by the Ventana IHC test. Sufficient tumor tissue to perform ALK IHC and ALK
- •FISH is required. Both tests will be performed at designated central laboratories.
- •Age ≥ 18 years old.
- •Life expectancy of at least 12 weeks.
- •ECOG PS of 0-2.
- •Patients had no prior systemic treatment for advanced or recurrent (Stage IIIB not
- •amenable for multimodality treatment) or metastatic (Stage IV) NSCLC.
- •Adequate hematologic function:
- •Platelet count ≥ 100 × 109/L
- •ANC ≥ 1500 cells/μL
- •Hemoglobin ≥ 9.0 g/dL
- •Adequate renal function:
- •Calculated creatinine clearance at least 45 mL/min
- •Patients must have recovered from effects of any major surgery or significant traumatic
- •injury at least 28 days before the first dose of study treatment.
- •Measurable disease (by RECIST v1.1) prior to the administration of study treatment.
- •Prior brain or leptomeningeal metastases allowed if asymptomatic and diagnosed
- •incidentally at study baseline. If patients have neurological symptoms or signs due to CNS
- •metastasis, patients need to complete whole brain radiation or gamma knife irradiation
- •treatment at least 14 days before enrollment and be clinically stable.
- •For all females of childbearing potential, a negative pregnancy test must be obtained within
- •3 days before starting study treatment.
- •For women who are not postmenopausal ( ≥ 12 months of non-therapy-induced amenorrhea)
- •or surgically sterile (absence of ovaries and/or uterus).
排除标准
- •Patients with a previous malignancy within the past 3 years are excluded (other than
- •curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by
- •endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered
- •to have no impact in PFS and OS for the current NSCLC).
- •Any GI disorder that may affect absorption of oral medications, such as mal-absorption
- •syndrome or status post-major bowel resection.
- •Liver disease characterized by:
- •ALT or AST > 3 × ULN (≥ 5 × ULN for patients with concurrent liver metastasis)
- •confirmed on two consecutive measurements
- •Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other
- •conditions of decompensated liver disease such as coagulopathy, hepatic
- •encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices
- •Acute viral or active autoimmune, alcoholic, or other types of hepatitis
- •National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
- •Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding
- •alopecia), which have not shown improvement and are strictly considered to interfere with
- •current study medication.
- •History of organ transplant.
- •Co-administration of anti-cancer therapies other than those administered in this study.
- •Patients with baseline QTc > 470 ms or patients with symptomatic bradycardia < 45 beats
- •per minute.
- •Administration of strong/potent cytochrome P4503A inhibitors or inducers within 14 days
- •prior to the first dose of study treatment and while on treatment with alectinib or crizotinib
- •except for oral corticosteroids up to 20 mg of prednisolone equivalent per day
- •Administration of agents with potential QT interval prolonging effects within 14 days prior to
- •the first administration of study drug and while on treatment.
- •History of hypersensitivity to any of the additives in the alectinib drug formulation (lactose
- •monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose,
- •sodium lauryl sulfate [SLS], magnesium stearate).
- •History of hypersensitivity to any of the additives in the crizotinib drug formulation (silica,
- •colloidal anhydrous cellulose, microcrystalline calcium hydrogen phosphate, anhydrous
- •sodium starch glycolate, magnesium stearate).
- •Pregnant or lactating women.
- •Known HIV positivity or AIDS-related illness.
研究者
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