A Phase IIa, Open-Label, Multi-Center, Multi-Cohort, Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Confirmed Complete Response (CR) Rate
研究概览
简要总结
Primary objective: To assess the efficacy of various sequences of either a small molecule or an IMT (IMT-A) followed by a IMT-B (MEDI4736) .
详细描述
This is a multi-arm, multi-cohort, Phase IIa, open-label study of selected small molecules (gefitinib, AZD9291, or selumetinib + docetaxel) or 1st IMT (hereafter referred to as IMT-A; tremelimumab) followed by sequential switch to a 2nd IMT (hereafter referred to as IMT-B; MEDI4736) in locally advanced or metastatic NSCLC (Stage IIIB-IV). Patients will be enrolled concurrently into multiple cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Provision of archived tumor tissue sample and mandatory tissue biopsy
- •Patients must have either histologically or cytologically documented NSCLC who present with locally advanced or metastatic stage IIIB-IV disease
- •Life expectancy ≥12 weeks
- •Patients must have measurable disease and at least 1 lesion not previously irradiated
- •World Health Organization (WHO) performance status of 0 or 1
排除标准
- •Mixed small cell and NSCLC histology
- •Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
研究组 & 干预措施
Gefitinib with a Seq. Switch to a MEDI4736
Gefitinib once daily followed by MEDI4736
干预措施: Gefitinib (Drug)
AZD9291 with a Seq. Switch to a MEDI4736
AZD9291 once daily followed by MEDI4736
干预措施: AZD9291 (Drug)
Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736
Selumetinib twice daily + docetaxel, followed by MEDI4736
干预措施: Selumetinib+Docetaxel (Drug)
Tremelimumab with a Seq. Switch to a MEDI4736
Tremelimumab every 4 weeks followed by MEDI4736
干预措施: Tremelimumab (Drug)
结局指标
主要结局
Confirmed Complete Response (CR) Rate
时间窗: Up to 2 years
To assess the efficacy of various sequences. CR (per RECIST 1.1 as assessed by the local/site Investigator) is defined as the disappearance of all target and non-target lesions. Confirmed complete response rate (CR rate) is defined as the number (%) of patients with a confirmed overall response of CR and was based on the evaluable analysis set.
次要结局
- Objective Response Rate (ORR)(Up to 2 years)
- Progression-free Survival(Up to 2 years)
- Duration of Response(Within 12 months)
- Overall Survival(Up to 2 years)