EUCTR2008-004454-33-PL进行中（未招募）不适用
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) - NEXT
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 1,200
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
- •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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