NCT00130728已完成3 期
A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 636
- 试验地点
- 4
- 主要终点
- Overall Survival (OS) Among All Randomized Patients
研究概览
简要总结
This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Cytologically or histologically confirmed NSCLC
- •Clinical or radiographic progression during or after first-line chemotherapy or chemoradiotherapy for NSCLC
- •Consent to provide archival tissue for analysis is required for participation in this study
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Age ≥ 18 years
- •Use of an acceptable means of contraception for men and women of childbearing potential
- •International normalized ratio (INR) no greater than 1.3 and an aPTT no greater than the upper limits of normal within 28 days prior to enrollment for patients not on low-molecular-weight heparin or fondaparinux
排除标准
- •Squamous cell carcinoma
- •Prior treatment with an investigational or marketed inhibitor of the Epidermal Growth Factor Receptor (EGFR) pathway or anti-angiogenesis agent
- •Systemic chemotherapy, radiotherapy, or investigational treatment within 28 days prior to randomization
- •Local palliative radiotherapy within 14 days prior to randomization or persistent adverse effects from radiotherapy that have not resolved to Grade 2 or less following completion of treatment
- •Whole brain radiotherapy or stereotactic radiosurgery for brain metastases within 4 weeks of Day 0
- •Neurosurgery for brain metastases within 24 weeks of Day 0
- •Brain biopsy within 12 weeks of Day 0
- •Current use of dexamethasone for treatment associated with brain metastases
- •History of gross hemoptysis within 3 months prior to randomization unless definitively treated with surgery or radiation
- •History of any of the following within 6 months prior to Day 0: serious systemic disease, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) Grade 2 or greater Congestive Heart Failure (CHF), unstable symptomatic arrhythmia requiring medication, clinically significant peripheral vascular disease, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
- •Evidence of bleeding diathesis or coagulopathy or other serious or acute internal bleeding within 6 months prior to randomization
- •Central Nervous System (CNS) bleeding; history or clinical evidence of CNS stroke (hemorrhagic or thrombotic) within the last 6 months
- •Progressive neurologic symptoms in patients with a history of brain metastases
- •Full-dose anticoagulation with warfarin
- •Chronic daily use of aspirin or other full-dose nonsteroidal anti-inflammatory drugs (NSAIDs) with anti-platelet activity
- •In-patient surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
- •Minor surgical procedure, fine needle aspirations or core biopsy within 7 days prior to randomization
- •Anticipation of need for a major surgical procedure during the course of the study
- •Serious, non-healing wound, ulcer, or bone fracture
- •Inability to take oral medication or requirement for intravenous (IV) alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption
- •Pregnancy or breast-feeding
- •Presence of another invasive cancer within 5 years prior to randomization
- •Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
研究组 & 干预措施
erlotinib HCl + bevacizumab
Experimental
oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
干预措施: bevacizumab (Drug)
erlotinib HCl + placebo
Placebo Comparator
oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
干预措施: erlotinib HCl (Drug)
erlotinib HCl + placebo
Placebo Comparator
oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
干预措施: placebo (Drug)
结局指标
主要结局
Overall Survival (OS) Among All Randomized Patients
时间窗: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)
Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.
次要结局
- Percentage of Participants With Objective Response(The median duration of Objective response was up to 9.7 months)
- Progression-free Survival (PFS)(From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years))
- Duration of Objective Response(Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months))
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Toripalimab or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLCTreatment-naive Advanced Non-small Cell Lung CancerNCT03856411Shanghai Junshi Bioscience Co., Ltd.465
已完成
3 期
A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background MethotrexateRheumatoid ArthritisNCT00266227Genentech, Inc.559
进行中（未招募）
3 期
Phase III Study of KX-826 With Adult Male Patients With AGAAndrogenetic AlopeciaNCT06126965Suzhou Kintor Pharmaceutical Inc,740
已完成
3 期
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-DopaParkinson DiseaseNCT01154166GlaxoSmithKline347
已完成
3 期
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive DisorderMajor Depressive DisorderNCT03672175Biogen581