EUCTR2008-004454-33-ES进行中（未招募）1 期
Open, randomized, multinational phase IIIb trial evaluating the activity and safety of cetuximab as 250 mg/m² weekly and 500 mg/m² every two weeks maintenance therapy after platinum-based chemotherapy in combination with cetuximab as first-line treatment for subjects with advanced non-small cell lung cancer (NSCLC).Estudio abierto, aleatorizado, multinacional en fase IIIb para evaluar la actividad y seguridad de cetuximab como tratamiento de mantenimiento a 250 mg/m2 una vez por semana y 500 mg/m2 cada dos semanas después de la quimioterapia a base de platino en combinación con cetuximab como tratamiento de elección en pacientes con cáncer de pulmón no microcítico (CPNM). - NEXT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Main inclusion criteria (for details see section 5.3.1):
- •? Subject has given written informed consents before any trial-related activities are carried out
- •? Male or female, ?18 years of age at the time of informed consent, inpatient or outpatient
- •? Adequate renal, hepatic and bone marrow function
- •? Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIB NSCLC with pleural effusion or stage IV
- •? Presence of at least 1 uni-dimensionally measurable index lesion, whereby index lesions must not lie in a previously irradiated area
- •? ECOG performance status of 0 or 1 at inclusion in the trial
- •? Effective contraception for male and female subjects, if risk of conception exists
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main exclusion criteria (for details see section 5.3.2):
- •? Previous exposure to EGFR-targeting therapy (not monoclonal antibodies in general or signal transduction inhibitors, which would be allowed)
- •? Previous chemotherapy for NSCLC; neo-adjuvant or adjuvant (radio-)chemotherapy is allowed if it was finished 6 months prior to start of trial treatment and no more than 300 mg/m² cisplatin was administered
- •? Major surgery within 30 days prior to inclusion in the trial
- •? Prior chest irradiation within 90 days prior to inclusion in the trial (palliative radiation of bone lesions is allowed)
- •? Participation in another clinical trial or treatment with any investigational agent(s) within 30 days prior to inclusion in the trial
- •? Documented or symptomatic brain metastasis
- •? Previous malignancy in the last 5 years except basal cell carcinoma of
- •the skin or pre-invasive carcinoma of the cervix
- •? Cardiovascular or neurological impairment or infection that prevent the
- •use of trial treatment
研究者
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