EUCTR2011-003719-42-GB进行中（未招募）1 期
A RANDOMIZED, PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF MetMAb IN COMBINATION WITH EITHER BEVACIZUMAB + PLATINUM + PACLITAXEL OR PEMETREXED + PLATINUM AS FIRST-LINE TREATMENT IN PATIENTS WITH STAGE IIIB or IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 259
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
- •Written informed consent
- •Male or female, 18 years of age or older
- •ECOG performance status of 0 or 1
- •Stage IIIB or Stage IV NSCLC tumors of non-squamous histology (Stage IIIB eligible only if stage T4 disease not amenable to definitive surgery or radiation therapy)
- •For patients who received prior adjuvant chemotherapy:
- •a treatment free interval of at least 12 months since the last chemotherapy cycle
- •Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
- •Adequate hematologic, hepatic, and renal function
- •Adequate contraception, during the treatment period and for at least 90 days after the last dose of study drug/placebo or 6 months after the last dose of paclitaxel
- •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 169
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 91
排除标准
- •Prior systemic treatment for Stage IIIB or IV non-squamous NSCLC
- •Mixed NSCLC histology with squamous cell predominance
- •Prior exposure to experimental treatment targeting either the HGF or Met pathway
- •Tumors confirmed to have EGFR activating mutations suitable for anti-EGFR therapy
- •Known central nervous system (CNS) disease, other than stable, treated brain metastasis
- •History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years (except for in situ cancer or basal or squamous cell skin cancer)
- •Serum calcium > ULN (corrected for low serum albumin concentrations)
- •Uncontrolled diabetes (fasting serum glucose level > 200 mg/dL)
- •Pregnancy or lactation
- •Significant history of cardiovascular disease
- •Serious active infection or other serious underlying medical conditions
- •Known HIV positivity
- •Any major surgery, major surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1, or an anticipated need for major surgery during the study
- •Known sensitivity to any component of cisplatin or carboplatin
- •(Patients with contraindications to bevacizumab or pemetrexed may not be included in those treatment cohorts)
研究者
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