A Biomarker-directed Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Whose Disease Has Progressed on First-Line Osimertinib Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.
详细描述
This is an open-label, multicentre, multi-drug, biomarker-directed Phase 2 platform study in patients with advanced non-small cell lung cancer (NSCLC) harbouring an epidermal growth factor receptor (EGFR)-sensitizing mutation whose disease has progressed on first-line monotherapy with osimertinib.Treatment options for these patients are limited. Novel treatments for these patients are urgently required.
This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Module 1: Osimertinib + Savolitinib
The patients in this group will receive osimertinib taken in combination with savolitinib
干预措施: Osimertinib (Drug)
Module 1: Osimertinib + Savolitinib
The patients in this group will receive osimertinib taken in combination with savolitinib
干预措施: Savolitinib (Drug)
Module 2: Osimertinib + Gefitinib
The patients in this group will receive osimertinib taken in combination with gefitinib
干预措施: Osimertinib (Drug)
Module 2: Osimertinib + Gefitinib
The patients in this group will receive osimertinib taken in combination with gefitinib
干预措施: Gefitinib (Drug)
Module 3: Osimertinib + Necitumumab
The patients in this group will receive osimertinib taken in combination with necitumumab
干预措施: Osimertinib (Drug)
Module 3: Osimertinib + Necitumumab
The patients in this group will receive osimertinib taken in combination with necitumumab
干预措施: Necitumumab (Drug)
Module 4: Carboplatin + Pemetrexed + Durvalumab)
The patients in this group will receive platinum-containing doublet (carboplatin + pemetrexed) taken in combination with durvalumab.
干预措施: Durvalumab (Drug)
Module 4: Carboplatin + Pemetrexed + Durvalumab)
The patients in this group will receive platinum-containing doublet (carboplatin + pemetrexed) taken in combination with durvalumab.
干预措施: Carboplatin (Drug)
Module 4: Carboplatin + Pemetrexed + Durvalumab)
The patients in this group will receive platinum-containing doublet (carboplatin + pemetrexed) taken in combination with durvalumab.
干预措施: Pemetrexed (Drug)
Module 5: Osimertinib + Alectinib
The patients in this group will receive osimertinib taken in combination with alectinib
干预措施: Osimertinib (Drug)
Module 5: Osimertinib + Alectinib
The patients in this group will receive osimertinib taken in combination with alectinib
干预措施: Alectinib (Drug)
Module 6: Osimertinib + Selpercatinib
The patients in this group will receive osimertinib taken in combination with selpercatinib
干预措施: Osimertinib (Drug)
Module 6: Osimertinib + Selpercatinib
The patients in this group will receive osimertinib taken in combination with selpercatinib
干预措施: Selpercatinib (Drug)
Module 7: Etoposide + Durvalumab + Carboplatin or Cisplatin
The patients in this group will receive platinum-containing doublet (etoposide + carboplatin or cisplatin) taken in combination with durvalumab.
干预措施: Durvalumab (Drug)
Module 7: Etoposide + Durvalumab + Carboplatin or Cisplatin
The patients in this group will receive platinum-containing doublet (etoposide + carboplatin or cisplatin) taken in combination with durvalumab.
干预措施: Carboplatin (Drug)
Module 7: Etoposide + Durvalumab + Carboplatin or Cisplatin
The patients in this group will receive platinum-containing doublet (etoposide + carboplatin or cisplatin) taken in combination with durvalumab.
干预措施: Etoposide (Drug)
Module 7: Etoposide + Durvalumab + Carboplatin or Cisplatin
The patients in this group will receive platinum-containing doublet (etoposide + carboplatin or cisplatin) taken in combination with durvalumab.
干预措施: Cisplatin (Drug)
Module 8: Osimertinib + Pemetrexed + Carboplatin or Cisplatin.
The patients in this group will receive Osimertinib plus platinum-containing doublet (pemetrexed + carboplatin or cisplatin).
干预措施: Osimertinib (Drug)
Module 8: Osimertinib + Pemetrexed + Carboplatin or Cisplatin.
The patients in this group will receive Osimertinib plus platinum-containing doublet (pemetrexed + carboplatin or cisplatin).
干预措施: Carboplatin (Drug)
Module 8: Osimertinib + Pemetrexed + Carboplatin or Cisplatin.
The patients in this group will receive Osimertinib plus platinum-containing doublet (pemetrexed + carboplatin or cisplatin).
干预措施: Pemetrexed (Drug)
Module 8: Osimertinib + Pemetrexed + Carboplatin or Cisplatin.
The patients in this group will receive Osimertinib plus platinum-containing doublet (pemetrexed + carboplatin or cisplatin).
干预措施: Cisplatin (Drug)
Module 9: Osimertinib + Selumetinib
The patients in this group will receive osimertinib taken in combination with selumetinib
干预措施: Osimertinib (Drug)
Module 9: Osimertinib + Selumetinib
The patients in this group will receive osimertinib taken in combination with selumetinib
干预措施: Selumetinib (Drug)
Module 10: Osimertinib + datopotamab deruxtecan
The patients in this group will receive osimertinib taken in combination with datopotamab deruxtecan.
干预措施: Osimertinib (Drug)
Module 10: Osimertinib + datopotamab deruxtecan
The patients in this group will receive osimertinib taken in combination with datopotamab deruxtecan.
干预措施: Datopotamab deruxtecan (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Measured from first dose until confirmed response or progression. For each patient this is expected to be 3 months on average
The percentage of patients with a confirmed investigator-assessed complete or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1. Patients will be followed up every 6 weeks (±1 week) for the first 24 weeks and every 9 weeks thereafter until RECIST 1.1 defined disease progression or cessation of study treatment (if treating beyond progression).
次要结局
- Progression-free survival (PFS)(Measured from first dose until progression. For each patient this is expected to be 6 months on average)
- Duration of response (DoR)(Measured from response until progression. For each patient this is expected to be 6 months on average)
- Overall survival (OS)(Measured from first dose until death or final cohort data cut-off. For each patient this is expected to be 20 months on average)
- Plasma/serum concentrations of therapeutic agents(Pre-dose and serial post-dose blood samples (1 hour, 2 hours, 4 hours, 6 hours, 8 hours) on Day 15 of Cycle 1 for alectinib and selpercatinib only.)
- Incidence of Treatment-emergent adverse events (AEs) and serious adverse events (SAEs) as characterized and graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event [CTCAE] v5(Continuously from first dose to end of safety follow up after study treatment discontinuation (approximately up to 21 Months))