An Open-Label Multicenter Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond RECIST Progression in NSCLC Patients Who Harbour EGFR Mutations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 22
- 主要终点
- Progression-free Survival Per RECIST, v. 1.1 (PFS1)
研究概览
简要总结
This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult participants, >/= 18 years of age
- •Stage IV or recurrent non-small cell lung cancer (NSCLC)
- •Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)
- •Measurable disease (at least one lesion >= 10 mm in longest diameter)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate hematological, renal and liver function
排除标准
- •Patients with T790M single mutation only
- •Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab
- •Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease
- •Symptomatic or uncontrolled central nervous system (CNS) metastases
- •Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast
- •Any significant ophthalmologic abnormality
- •Pre-existing parenchymal lung disease such as pulmonary fibrosis
- •Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)
研究组 & 干预措施
Erlotinib
Erlotinib 150 mg daily
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression-free Survival Per RECIST, v. 1.1 (PFS1)
时间窗: Approximately 68 months
PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
次要结局
- Progression-free Survival Per Investigator (PFS2)(Approximately 68 months)
- Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R(Approximately 68 months)
- Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R(Approximately 68 months)
- Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)(Approximately 68 months)
- Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R(Approximately 68 months)
- Number of Participants With Adverse Events(Approximately 68 months)
- Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS)(Approximately 68 months)