EUCTR2016-002621-10-CZ进行中（未招募）1 期
A Phase IIIb/IV Safety Trial of Flat Dose Nivolumab in Combination with Ipilimumab in Participants with Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,240
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
- •- Signed Written Informed Consent
- •- Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
- •- Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer) for cohort A, B and C
- •- No prior systemic anticancer therapy (including EGFR and ALK inhibitors) for cohort A, A1 and C
- •- Tissue or Programmed death-ligand 1 (PD-L1) results available
- •Cohort 1A Inclusion Criteria:
- •- Eastern Cooperative Oncology Group (ECOG) score 2 or
- •- Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol
- •Cohort C Inclusion Criteria:
- •- High Tumor Mutation Burden
- •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 1120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1120
排除标准
- •- Untreated brain metastases
- •- An active malignancy that requires concurrent intervention
- •- Active, known or suspected autoimmune disease
- •- Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer
研究者
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