EUCTR2006-006624-19-GB进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE IIIb TRIAL COMPARING BEVACIZUMAB THERAPY WITH OR WITHOUT ERLOTINIB AFTER COMPLETION OF CHEMOTHERAPY WITH BEVACIZUMAB FOR THE FIRST-LINE TREATMENT OF LOCALLY ADVANCED, RECURRENT, OR METASTATIC NON–SMALL CELL LUNG CANCER
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Subjects must have advanced NSCLC without prior systemic treatment for locally
- •advanced, recurrent, or metastatic disease. This includes subjects with Stage IIIB
- •with malignant pleural effusion or Stage IV or recurrent disease.
- •Signed Informed Consent Form
- •Histologically or cytologically confirmed NSCLC. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present. Cytologic or histologic elements may be established on metastatic tumor aspirates or biopsy
- •Advanced NSCLC (Stage IIIB with malignant pleural effusion or Stage IV) or recurrent disease Subjects with squamous cell carcinoma are eligible provided that their disease is extrathoracic or that their intrathoracic disease consists of peripheral lesions only. A peripheral lesion is defined as a lesion (or lesions), in which the epicenter of the tumor is = 2 cm from the costal or diaphragmatic pleura in a 3-dimensional orientation based on each lobe of the lung and is > 2 cm from the trachea, main, and lobar bronchi.
- •Subjects with a history of brain metastases are eligible for study participation as long as their brain metastases have been treated, and they do not have an ongoing requirement for treatment with dexamethasone at screening. Treatment must be with whole-brain radiotherapy (e.g., 3000 cGy over 2 weeks) and may include neurosurgery or stereotactic radiosurgery. Radiotherapy and stereotactic radiosurgery must be completed at least 4 weeks prior to Day 1 (chemotherapy phase).
- •Neurosurgery must be completed at least 24 weeks prior to Day 1 (chemotherapy phase), and brain biopsy must be completed at least 12 weeks prior to Day 1 (chemotherapy phase).
- •Note: All subjects require a brain imaging (MRI or CT with contrast) within 28 days of enrollment.
- •INR no greater than 1.3 and aPTT no greater than upper limits of normal (ULN) within 28 days prior to enrollment for subjects not on low molecular weight heparin or fondaparinux. Subjects on low molecular weight heparin or fondaparinux are not required to meet INR or aPTT limits. Chronic full-dose anticoagulation with warfarin is not permitted.
- •ECOG performance status of 0 or 1
- •18 years of age or older
- •For women of childbearing potential and sexually active men, use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to enrollment and for the duration of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior systemic chemotherapy in the metastatic setting. Prior adjuvant therapy and prior combined modality therapy is allowed provided that there is an interval of at least 6 months prior to recurrence.
- •Treatment with an investigational or marketed agent that acts by either EGFR inhibition or anti-angiogenesis mechanisms EGFR inhibitors include (but are not limited to) erlotinib, gefitinib, cetuximab, and CI-1033. Angiogenesis inhibitors include (but are not limited to) bevacizumab, thalidomide, CP-547632, sunitinib, and sorafinib.
- •Pregnancy or lactation
- •Any other medical condition, including mental illness or substance abuse, deemed by the clinician to be likely to interfere with a subject’s ability to provide informed consent, cooperate, and participate in the study, or to interfere with the interpretation of the results
- •Active infection or a fever > 38.5°C (>101.3°F) within 3 days of enrollment
- •Active malignancy other than lung cancer
- •Radiation therapy to sites other than whole brain within 14 days prior to enrollment
- •Those who have not recovered from adverse events because of radiation therapy remain ineligible until resolution of all radiation-related toxicities to Grade = 1.
- •History of gross hemoptysis (defined as bright-red blood of a half-teaspoon or
- •more) within 3 months prior to enrollment
- •Known hypersensitivity to any of the components of cytotoxic chemotherapy
- •combinations, bevacizumab, or tyrosine kinase inhibitors
- •Inadequately controlled hypertension (blood pressure systolic > 150 mmHg or
- •diastolic >100 mmHg)
- •(Refer to http://www.nhlbi.nih.gov/guidelines/hypertension/jncintro.htm for JNC 7guidelines regarding suggestions on measurement.)
- •Unstable angina or New York Heart Association Grade II or greater CHF
- •Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment
- •History of myocardial infarction within 6 months prior to enrollment
- •History of stroke within 6 months prior to enrollment
- •Symptomatic peripheral vascular disease within 6 months prior to enrollment
- •Evidence of bleeding diathesis or coagulopathy
- •Urine protein/creatinine ratio = 1.0 at screening
- •Microalbuminuria assay or urine dipstick assays are not permitted as a substitute for the urine protein assay.
- •Serious, non-healing wound, ulcer, or bone fracture
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment; anticipation of need for major surgical procedure during the course of the study
- •Exclusionary laboratories:
- •Neutrophils < 1500/mm3; platelet count < 100,000/mm3; hemoglobin < 9 g/dL
- •AST > 2.5 × ULN; ALT > 2.5 × ULN in the absence of liver metastasis or > 5 × ULN in case of liver metastasis
- •Alkaline phosphatase > 2.5 × ULN; if alkaline phosphatase is > 2.5 × ULN,
- •then AST and ALT must be < 1.5 × ULN
- •Total bilirubin > 1.5 × ULN
- •Creatinine > 1.5 × ULN
- •Current, recent (within 4 weeks of the first infu
研究者
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