A Multi-centre, Open-label, Phase IV, Interventional Study to Evaluate the Efficacy of Erlotinib (Tarceva®) Following 4 Cycles of Platinum-based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Percentage of Participants With Progression-free Survival at Week 52
研究概览
简要总结
This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 patients ≥ 18 years of age.
- •Histologically documented non-small cell lung cancer (NSCLC).
- •Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
- •Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients of reproductive potential must agree to use effective contraception.
排除标准
- •Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
- •Prior treatment with any monoclonal antibody therapy.
- •Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
- •Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
- •Pre-existing interstitial lung disease.
- •Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- •Pregnant or lactating women.
研究组 & 干预措施
Erlotinib
Participants received erlotinib 150 mg orally once a day for 48 weeks.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Percentage of Participants With Progression-free Survival at Week 52
时间窗: From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).
A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
次要结局
- Progression-free Survival (PFS)(From the date of enrolment until the end of the study (up to 2 years, 6 months).)
- Overall Survival(From the date of enrolment until the end of the study (up to 2 years, 6 months).)
- Percentage of Participants With Disease Control(From the date of enrolment until the end of the study (up to 2 years, 6 months).)
- Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)(From the date of enrolment until the end of the study (up to 2 years, 6 months).)