A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 324
- 试验地点
- 82
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of well-differentiated neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET)
- •Measurable disease per RECIST 1.1
- •Somatostatin receptor positive (SSTR+) disease
- •Progressive disease based on RECIST 1.
- •criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)
排除标准
- •Known hypersensitivity to edotreotide or everolimus
- •Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative
- •Prior exposure to any peptide receptor radionuclide therapy (PRRT)
- •Prior therapy with mTor inhibitors
- •Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy
- •Therapy with an investigational compound and/or medical device within 30 days prior to randomisation
- •Indication for surgical lesion removal with curative potential
- •Planned alternative therapy (for the period of study participation)
- •Serious non-malignant disease
- •Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments
- •Pregnant or breast-feeding women
- •Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.).
研究组 & 干预措施
177Lu-edotreotide PRRT
177Lu-edotreotide (177Lu-DOTATOC)
A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each.
Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)
干预措施: Amino-Acid Solution (Other)
177Lu-edotreotide PRRT
177Lu-edotreotide (177Lu-DOTATOC)
A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each.
Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)
干预措施: 177Lu-edotreotide PRRT (Drug)
Everolimus
Everolimus (Afinitor ®)
Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)
干预措施: Everolimus (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From date of randomization until the date of first documented progression or death, assessed up to 30 months,
PFS determined as time elapsed between randomization, and the date of first objective report of tumor progression (evaluated by RECIST criteria v1.1) as evaluated by the Blinded Independent Central Review (BICR), or death.
progression-free survival (PFS)
时间窗: 12 weeks +/- 14 days, up to 30 months
PFS will be assessed individually per patient from date of randomization until the date of first documented progression or death, assessed up to 30 months, primary outcome will be measured by CT/MRI every 12 weeks +/- 14 days
次要结局
- Objective Response Rate (ORR)(Up to 30 months)
- Overall Survival (OS)(Overall Survival (OS) will be followed up for 5 years (60 months) after the End of Study (EOS))
- objective response rates (ORR)(12 weeks +/- 14 days, up to 30 months)
- overall survival (OS)(12 weeks +/- 14 days, up to 90 months)