A Multicenter, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva®) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 217
- 主要终点
- Investigator-assessed Duration of Progression-free Survival
研究概览
简要总结
This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m^2 iv on Day 1.
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
- 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.
- •Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
- •Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
- •Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
- •European Cooperative Oncology Group (ECOG) performance status ≤ 2.
排除标准
- •Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).
- •Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.
- •Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.
- •Any inflammatory changes of the surface of the eye.
- •≥ Grade 2 peripheral neuropathy.
- •History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
- •Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.
- •Human immunodeficiency virus (HIV) infection.
- •Pregnant, nursing, or lactating women.
研究组 & 干预措施
Erlotinib
Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
干预措施: Erlotinib (Drug)
Chemotherapy
Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Investigator-assessed Duration of Progression-free Survival
时间窗: Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)
The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first. PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (2) An unequivocal progression of existing non-target lesions. When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy. When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease. (3) The appearance of new malignant lesions.
次要结局
- Percentage of Participants With Disease Control(Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months))
- Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire(approximately 21 months)
- Duration of Response(Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months))
- Safety: Incidence of Adverse Events(36 months)
- Percentage of Responders as Assessed by the Investigator(Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months))
- Overall Survival(Baseline to the end of the study (3 years, 1 month))