An Open-label, Randomized, Phase II Study of Erlotinib Monotherapy Versus Docetaxel and Cisplatin as Neoadjuvant Therapy in Patients of Stage IIIA Lung Adenocarcinoma With Epidermal Growth Factor Receptor Gene Mutation.
试验速览
- 阶段
- 2 期
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Number of Adverse Event
研究概览
简要总结
To compare clinical response (complete response and partial response) by RECIST) rates by RECIST between erlotinib monotherapy and docetaxel plus cisplatin chemotherapy
详细描述
an open-label, multi-centre, randomized, phase II study evaluating efficacy of erlotinib monotherapy vs. docetaxel plus cisplatin chemotherapy.
Patients with histological documented stage IIIA lung adenocarcinoma. The tumor specimens were examined for EGFR gene mutation (Exon 18-21).
Those with exon 19 deletion and L858R, G719X, L861Q mutation were randomized as erlotinib monotherapy or docetaxel plus cisplatin chemotherapy.
The randomization will be stratified by center
Study treatment Patients will receive treatment for 9 weeks unless disease progression, unacceptable toxicity or death.
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
- •• Age ≥ 18 years, male or female
- •Able to comply with the protocol
- •Histologically documented stage IIIA lung adenocarcinoma
- •ECOG performance status 0-2
- •If the patient has the use coumarin (coumarin) (also to be called coumadin or warfarin), the patient applies drugs previous 7 days at the experiment to stop the medicine, and changes to other for to use the medicine.
- •Life expectancy > 12 weeks
- •Tumor specimen with EGFR gene mutation of exon 19 deletion and L858R, G719X, L861Q mutation
- •Adequate hematological function: ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, Hb ≥ 9 g/dL
- •Data of INR and PTT should be available in patients taking anticoagulants concomitantly, with INR ≤ 1.5 and PTT ≤ 1.5 times the upper limit of normal (x ULN ) within 7 days prior to starting study treatment
- •Adequate liver function: serum bilirubin ≤ 1.5 x ULN; transaminases ≤ 2.5 x ULN
- •Adequate renal function: 24-hour urine creatinine clearance or creatinine clearance measured and calculated according to the formula of Cockroft and Gault ≥ 60ml/min
- •Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women
- •Written informed consent.
- •Patients are willing to complete FACT-L, ED-5Q, or pharmacoeconomic questionnaires
排除标准
- •• Prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor)
- •Mixed adenocarcinoma and other histological type of lung cancer
- •Unable to take oral medicine
- •Pregnant or lactating women
- •Fertile men or women of childbearing potential not using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
- •Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent
- •Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to starting study treatment
- •Known hypersensitivity to any of the study drugs
- •Concurrent cancer treatment
研究组 & 干预措施
erlotinib
Patients in erlotinib arm will take erlotinib 150mg/day for 9 weeks unless disease progression, unacceptable toxicity or death.
干预措施: erlotinib (Drug)
Chemotherapy
Patients in chemotherapy arm will then receive 3 cycles (9 weeks) of chemotherapy with docetaxel 35mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 8.
Treatment failure will include patients who fail to complete 3 cycles (9 weeks) of study treatments due to disease progression or unacceptable toxicity.
Patients with no disease progression after terminating study treatment will undergo surgical resection and be followed until disease progression is noted, or study end. Survival will be recorded and analyzed.
If progressive disease or unacceptable toxicity occurs during study treatments, patients will be treated at discretion of investigator according to local protocol.
干预措施: docetaxel (Drug)
结局指标
主要结局
Number of Adverse Event
时间窗: Within 28 days of last study dose
次要结局
未报告次要终点