A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs

What Was Tested

This registered phase 3 trial tested Octreotide.

It had two arms (groups): Lutetium[177Lu] Oxodotreotide Injection (experimental) and Octreotide LAR (active comparator).

The registry classes the interventions as drug.

More on the Plan

After the screening period, participants who signed the ICF and were eligible for the study in accordance with the entry criteria were randomly assigned to treatment either Lutetium\[177Lu\] Oxodotreotide Injection or Octreotide LAR.

Who Took Part

Enrollment: 196 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to understand and willingness to sign a written informed consent document. Aged 18 years or older. Presence of disease progression prior to randomization (time point of disease progression limited to 1 year prior to randomization and no other antitumor therapy received after progression). Presence of at least 1 measurable site of disease (based on RECIST 1.1). All target lesions (based on RECIST 1.1) at baseline must be confirmed as somatostatin receptor positive by 68Ga-Dotatate PET/CT .

The full record lists 9 inclusion and 26 exclusion criteria; among the exclusions: serum total bilirubin \> 3 × upper limit of normal (uln); alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2.5×uln; international normalized ratio (inr) \> 1.5 or partially activated prothrombin time (aptt) \> 1.5 x uln.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-08-31 with completion listed for 2024-06-26.

It ran at 23 sites in China (23).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression Free Survival (PFS) assessed by BIRC.

It also tracked 15 secondary outcomes, for example Progression Free Survival (PFS) assessed by investigator, Objective Response Rate (ORR) assessed by investigator, Objective Response Rate (ORR) assessed by BIRC, Duration of Response (DoR) assessed by investigator, Duration of Response (DoR) assessed by BIRC and Time to Tumour Progression (TTP) assessed by investigator.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 196 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.