JPRN-jRCT2080222742已完成2 期
A Phase 2, Non-comparative, Open Label, Multi-centre, International Study of MEDI4736, in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least 2 Prior Systemic Treatment Regimens Including 1 Platinum-based Chemotherapy Regimen (ATLANTIC)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Documented evidence of NSCLC (stage IIIB/IV disease)
- •- Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC
- •- World Health Organisation (WHO) Performance Status of 0 or 1
- •- Estimated life expectancy of more than 12 weeks
- •- Patient's tumour sample must be PD-L1 positive (25% or more of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with 90% or more of tumour cells with membrane staining (Cohort 3))
排除标准
- •- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
- •- Brain metastases or spinal cord compression or unless asymptomatic, treate d and stable (not requiring steroids ).
- •- Active or prior autoimmune disease or history of immunodeficiency.
- •- Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
- •- Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
- •- Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.
- •- Any prior Grade 3 or more 3 immune or more-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1.
- •- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
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