NCT00300586已完成3 期
A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer Not Progressing on First Line Cisplatin-gemcitabine Chemotherapy Maintenance Chemotherapy With Gemcitabine or Sequential Treatment With Erlotinib
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 842
- 试验地点
- 1
- 主要终点
- Progression free survival since randomization
研究概览
简要总结
The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival :
- Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity.
- Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented NSCLC (tumor tissue samples will be provided to look for assessment of EGFR status with CISH, immunochemistry and mutations) : adenocarcinoma, squamous cell carcinoma, large cell carcinoma. A cytological documentation of NSCLC is accepted.
- •Stage IV disease or metastatic relapse in not previously irradiated areas of a NSCLC previously treated with surgery or radiation therapy (with a histologically documented proof of relapse) or stage III B with documented pleural involvement.
- •Measurable disease according to the RECIST criteria.
- •Prior radiotherapy authorized except for irradiation concerning measurable disease.
- •Age >18 and < 70 years.
- •Normal hepatic function : serum bilirubin < 1.5 ULN, SGOT (ASAT) and SGPT (ALAT) < 2,5 ULN ; in presence of liver metastases, SGOT and SGPT must be < 5 x ULN.
- •Creatinine clearance > 60 mL/min.
- •Granulocyte count > 1,5 giga/L, platelet count > 100 giga/L.
- •Life expectancy > 12 weeks.
- •Written (signed) informed consent for use of tumors samples.
- •Written (signed) informed consent to participate in the sudy.
排除标准
- •Small cell lung cancer, bronchiolo-alveolar carcinoma, neuro-endocrine carcinoma.
- •Prior chemotherapy other than cisplatin-gemcitabine.
- •Prior therapy with EGFR inhibitor (e.g. monoclonal antibody).
- •No concomitant therapy with phenytoin, carbamazepine, rifampicine or phenobarbital.
- •Concomitant radiotherapy except for localized bone irradiation.
- •Symptomatic brain metastases.
- •Superior vena cava syndrome.
- •Any unstable systemic disease : significant cardiovascular disease including myocardial infarction within the previous year, active infection, significant hepatic or renal disease.
- •Pre-existing interstitial lung disease.
- •Any inflammatory changes of the surface of the eyes.
- •Psychiatric disease with inability to understand the study or to comply with follow-up procedures.
- •Grade > or = 2 peripheral neuropathy.
- •Any other malignancies within 5 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer).
- •Pregnant or lactating women ; patients with reproductive potential must use effective contraception.
- •Inability to comply with follow-up procedures.
研究组 & 干预措施
A (supervision)
Sham Comparator
medical supervision, second line chemotherapy if progression
干预措施: observation (Drug)
B (gemcitabicine)
Active Comparator
Maintenance treatment (gemcitabicine 1250 mg/m² J1, J8 (repeated cycles every 21 days), second line chemotherapy if progression
干预措施: gemcitabine (Drug)
C (Erlotinib)
Experimental
Treatment by erlotinib 150 mg/day (sequential treatment), second line chemotherapy if progression
干预措施: erlotinib (Drug)
结局指标
主要结局
Progression free survival since randomization
时间窗: time until progression
次要结局
- Overall survival,(no time limit)
- toxicity (NCIC-CTC 3.0),(time until progression)
- quality of life (as assessed by LCSS).(until progression)
研究者
研究点 (1)
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