A Phase II,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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 446
- 试验地点
- 139
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability
详细描述
This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736 (Durvalumab), in patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer. MEDI4736 will be investigated in patients who have received at least two prior treatment regimens including one platinum-based chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 18 years.
- •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%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% 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, treated 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 immune-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)
研究组 & 干预措施
MEDI4736
see below
干预措施: MEDI4736 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Patients commenced treatment with durvalumab on Day 1 and continued on a Q2W schedule for a maximum of 12 months. Tumor assessments using computed tomography / magnetic resonance imaging were performed every 8 weeks. Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) measurements as given by the Independent Central Review (ICR) were used to derive the primary variable of ORR .
次要结局
- Time to Response (TTR)(Responses recorded during initial 12 month treatment period (up to primary analysis DCO))
- Duration of Response (DoR)(Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO))
- Overall Survival (OS)(From date of first treatment until final DCO (up to approximately 3 years 8 months))