This is a multicenter, single-arm, two-part study designed to evaluate the safety and efficacy of Lutetium \[177Lu\] Oxyoctreotide Injection in patients with inoperable, locally advanced or metastatic, progressive, advanced somatostatin receptor (SSTR) positive neuroendocrine neoplasms (NEN) other than grade G1/G2 gastroenteropancreatic neuroendocrine tumors (GEP-NET).
This study consists of two parts, the exploratory study (Part 1) and the pivotal study (Part 2). In both parts, participants who signs Informed consent form (ICF) and is eligible for the study will be enrolled. Participants will receive 7.4GBq (200mCi) Lutetium \[177Lu\] Oxyoctreotide every 8 weeks. The objective tumor response will be assessed every 12 weeks from the time of the first dose according to RECIST 1.1 until disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Participants will receive 7.4GBq (200mCi) Lutetium\[177Lu\] Oxodotreotide Injection every 8 weeks.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Incidence and severity of adverse events (AE) (Part1)
Time frame: Until 6 months after the last dose
Overall Response Rate (ORR) assessed by Independent Review Committee (IRC) (Part 2)
Time frame: Until disease progression or death, up to 5 years
Overall Response Rate (ORR) (Part 1)
Time frame: Until disease progression or death, up to 5 years
Progression-free survival (PFS) (Part 1)
Time frame: Until disease progression or death, up to 5 years
Disease Control Rate (DCR) (Part 1)
Time frame: Until disease progression or death, up to 5 years
Duration of Overall Response (DoR) (Part 1)
Time frame: Until disease progression or death, up to 5 years
Time to Progression (TTP) (Part 1)
Time frame: Until disease progression or death, up to 5 years
PFS rate at 12 months (Part 1)
Time frame: At 12 months after the first dose
Overall Survival (OS) (Part 1)
Time frame: Until death of any cause, up to 5 years
Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 1)
Time frame: Until disease progression or death, up to 5 years
Change From Baseline in the EORTC Quality of Life Questionnaire (Part 1)
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Time frame: Until disease progression or death, up to 5 years
Progression-free survival (PFS) (Part 2)
Time frame: Until disease progression or death, up to 5 years
Disease Control Rate (DCR) (Part 2)
Time frame: Until disease progression or death, up to 5 years
Duration of Overall Response (DoR) (Part 2)
Time frame: Until disease progression or death, up to 5 years
Time to Progression (TTP) (Part 2)
Time frame: Until disease progression or death, up to 5 years
PFS rate at 12 months (Part 2)
Time frame: At 12 months after the first dose
Overall Survival (OS) (Part 2)
Time frame: Until death of any cause, up to 5 years
Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 2)
Time frame: Until disease progression or death, up to 5 years
Change From Baseline in the EORTC Quality of Life Questionnaire (Part 2)
Time frame: Until disease progression or death, up to 5 years
Incidence and severity of AE (Part2)
Time frame: Until 6 months after the last dose