A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 14
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to assess if the combination of erlotinib and chemotherapy (docetaxel in case of squamous cell NSCLC or pemetrexed in case of other histological types) is superior to erlotinib alone and has acceptable tolerability and safety in the 2nd line treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC).
详细描述
Open randomized multicenter phase II study in patients in need of 2nd line treatment for advanced/metastatic NSCLC. Efficacy and safety of monotherapy with erlotinib will be compared with combination therapy of erlotinib and chemotherapy. In recent studies it was established that pemetrexed activity is more pronounced in non-squamous NSCLC in comparison to squamous cell carcinoma. Therefore in patients with non-squamous carcinoma pemetrexed will be used. As in second line treatment of NSCLC docetaxel is registered also for usage in patients with squamous cell carcinoma, docetaxel will be used in patients with squamous histology.
Chemotherapy will be limited to 4 courses. Erlotinib will be continued until disease progression or unacceptable toxicity.
Erlotinib as monotherapy will be administered continuously. In combination with chemotherapy, erlotinib will be given from day 2-16 of every course of 3 weeks.
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
- •Histologically or cytologically confirmed NSCLC, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one or two cytotoxic treatment regimens which should have included a platinum agent.
- •Complete recovery from prior chemotherapy side effects to < Grade
- •At least one unidimensional measurable lesion meeting RECIST criteria.
- •Age > 18 years.
- •Adequate organ function, including:
- •Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
- •Hepatic: bilirubin <1.5 x ULN, AP, ALT, AST < 1.5 x ULN AP, ALT, and AST <5 x ULN is acceptable if the liver has tumor involvement
- •Renal: calculated creatinin clearance > 40 ml/min based on the Cockcroft-Gault formula.
- •Estimated life expectancy >12 weeks.
- •Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
- •Signed informed consent.
- •Patient compliance and geographical proximity that allow adequate follow up.
排除标准
- •Pregnant or lactating women.
- •Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
- •Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment.
- •Previous treatment with an EGFR-TKI, or in non-squamous histology earlier treatment with pemetrexed and in squamous earlier treatment with docetaxel.
- •Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (5 day period for long-acting agents such as piroxicam).
- •Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
- •Concomitant treatment with any other experimental drug under investigation.
研究组 & 干预措施
1
Erlotinib plus docetaxel (squamous cell NSCLC) or pemetrexed (non-squamous cell NSCLC)
干预措施: erlotinib plus docetaxel or pemetrexed (Drug)
2
Erlotinib
干预措施: erlotinib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From randomisation to date of first progression or date of death, assessed up to 36 months
to compare the PFS in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent Progression free survival
次要结局
- Number of Adverse Events(From randomisation to 30 days after EoT all AEs are collected)