Assess the Incidence of Mutations in the Tyrosine Kinase Domain of the Endothelial Growth Factor Receptor in UK Patients With Newly Diagnosed Metastatic or Recurrent Non-small Cell Lung Cancer and to Investigate the Quality of Life of These Patients Undergoing First-line Therapy With Erlotinib.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 688
- 主要终点
- Percentage of Participants With EGFR Mutations by Subgroup
研究概览
简要总结
This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line Tarceva (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. Patients with negative EGFR mutation results will be offered treatment as per the centre's standard of care.
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 patients, >/= 18 years of age
- •Locally advanced or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC)
- •ECOG performance status 0-3
- •Treatment phase: histologically confirmed EGFR exon 19 deletion or exon 21 mutation in the diagnostic phase of the study
- •Adequate haematological, liver and renal function
- •Female patients must be postmenopausal, surgically sterile, or agree to use a barrier method of contraception
- •Male patients must be surgically sterile or agree to use a barrier method of contraception
排除标准
- •Previous treatment for NSCLC with chemotherapy or therapy against EGFR, either with antibody or small molecule (tyrosine kinase inhibitor)
- •Symptomatic cerebral metastases
- •Pregnant or lactating women
- •Any other concomitant anti-cancer therapy (until disease progression and discontinuation of Tarceva therapy)
研究组 & 干预措施
Single Arm
干预措施: erlotinib [Tarceva] (Drug)
结局指标
主要结局
Percentage of Participants With EGFR Mutations by Subgroup
时间窗: 14 Days
Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history.
Percentage of Participants Who Tested Positive for EGFR Mutations
时间窗: 14 days
All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations.
次要结局
- Probability of Being Alive and Free of Progression by Timepoint(Months 0, 3, 6, 9, 12, 15, and 18)
- Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D(Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months)
- Percentage of Participants With a Response by Best Objective Tumor Response(Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months)
- Survival Time in Months(Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months)
- Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument(Screening, Baseline and Final or Withdrawal Visit up to 34 months)
- Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D(Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months)
- Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D(Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months)
- Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D(Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months)
- Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D(Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months)