Randomised, Controlled Study Comparing Chemotherapy Plus Intercalated EGFR-Tyrosine Kinase Inhibitors Combination Therapy With EGFR-Tyrosine Kinase Inhibitors Alone Therapy as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 4 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Objective: To compare the efficacy and safety of chemotherapy plus intercalated EGFR-tyrosine kinase inhibitors (TKI) combination therapy with TKI alone therapy as first-line treatment for patients with non-small-cell lung cancer (NSCLC).
Methods: Patients with untreated, stage IIIB/IV, EGFR mutation-positive NSCLC will be randomly assigned to combination therapy group (receiving four cycles of docetaxel or pemetrexed (on day 1) plus platinum (on day 1) with intercalated TKI (gefitinib, erlotinib or Icotinib, on day 2-15) every 3 weeks) or TKI alone therapy (gefitinib, erlotinib or Icotinib, daily). All patients were continued to receive TKI until progression or unacceptable to toxicity or death. The primary endpoint was progression-free survivial (PFS).
Expected results: PFS of combination therapy group will be prolonged to nineteen months while PFS of TKI alone therapy group is ten months. Overall survival (OS) of combination therapy group will be prolonged to 36 months while OS of TKI alone therapy group is 26 months.
Hypothesis: Platinum-based chemotherapy plus intercalated TKI combination therapy as first-line treatment will prolong PFS and OS for patients with NSCLC.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >=18 years of age;
- •Advanced (stage IIIB/IV) non-small-cell lung cancer;
- •Although stageⅠ-ⅢA, have contraindications to surgery;
- •EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21);
- •Measurable disease;
- •ECOG Performance Status 0 or 1 or 2.
排除标准
- •Wild-type EGFR;
- •Prior exposure to agents directed at the HER axis;
- •Prior chemotherapy or systemic anti-tumor therapy after advanced disease;
- •Unstable systemic disease;
- •Any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
- •Brain metastasis or spinal cord compression.
研究组 & 干预措施
Combination therapy
Interventions:
Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana] plus Drug: Docetaxel for patients of lung squamous cell carcinoma; Pemetrexed for patients of lung adenocarcinoma plus Drug: Platinum (cisplatin or carboplatin)
干预措施: Erlotinib (Drug)
Combination therapy
Interventions:
Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana] plus Drug: Docetaxel for patients of lung squamous cell carcinoma; Pemetrexed for patients of lung adenocarcinoma plus Drug: Platinum (cisplatin or carboplatin)
干预措施: Gefitinib (Drug)
Combination therapy
Interventions:
Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana] plus Drug: Docetaxel for patients of lung squamous cell carcinoma; Pemetrexed for patients of lung adenocarcinoma plus Drug: Platinum (cisplatin or carboplatin)
干预措施: Icotinib (Drug)
Combination therapy
Interventions:
Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana] plus Drug: Docetaxel for patients of lung squamous cell carcinoma; Pemetrexed for patients of lung adenocarcinoma plus Drug: Platinum (cisplatin or carboplatin)
干预措施: Docetaxel (Drug)
Combination therapy
Interventions:
Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana] plus Drug: Docetaxel for patients of lung squamous cell carcinoma; Pemetrexed for patients of lung adenocarcinoma plus Drug: Platinum (cisplatin or carboplatin)
干预措施: Pemetrexed (Drug)
Combination therapy
Interventions:
Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana] plus Drug: Docetaxel for patients of lung squamous cell carcinoma; Pemetrexed for patients of lung adenocarcinoma plus Drug: Platinum (cisplatin or carboplatin)
干预措施: Platinum (cisplatin or carboplatin) (Drug)
TKI alone therapy
Interventions:
Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana]
干预措施: Erlotinib (Drug)
TKI alone therapy
Interventions:
Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana]
干预措施: Gefitinib (Drug)
TKI alone therapy
Interventions:
Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana]
干预措施: Icotinib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 8 weeks
Progression-free survival (PFS) is defined to be the time from randomization to progression of disease or death, whichever occurs first. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
次要结局
- Objective response rate(8 weeks)
- Overall survival (OS)(8 weeks)
- Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory data(4 weeks)
- Time to progression(8 weeks)
- Clinical benefit rate(8 weeks)
- Duration of response(8 weeks)
研究者
Qian Qi
assistant director
Qilu Hospital of Shandong University