Efficacy and Safety of Lanreotide Autogel/ Depot [amount hidden] vs. Placebo in Subjects With Lung Neuroendocrine Tumours

What Was Tested

In this phase 3 trial, researchers set out to test Lanreotide.

This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Phase.

The DB Phase includes: Screening, Baseline and Treatment period.

It had two arms (groups): Lanreotide (Autogel formulation) (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

At the time of the premature stop of the recruitment (as per Protocol Amendment #5), 77 patients were enrolled.

All patients still treated in the DB Phase were entered into the OL Phase (either for Follow up or for OL treatment periods).

The transition to the OL periods was done on a country-basis and per patient, at the following planned scheduled visit (i.e. approximately 28 days from the last injection).

Patients enrolled into the study not progressing at the time of study stop, and who agree to stay on LAN therapy (i.e.

Who Took Part

Enrollment: 77 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: Have metastatic and/or unresectable pathologically confirmed well-differentiated, typical or atypical neuroendocrine tumor of the bronchopulmonary. Histologic evidence of Well differentiated Neuroendocrine tumors (NETs) of the bronchopulmonary (typical and atypical according to the World Health Organisation (WHO criteria), evaluated locally). Has a mitotic index \<2 mitoses/2 mm2 for typical carcinoid (TC) and \<10 mitoses/2 mm2 and/or foci of necrosis for atypical carcinoid (AC). At least one measurable lesion of the disease on imaging (CT or MRI; RECIST 1.1). Positive Somatostatin receptors (SSTR) imaging.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: poorly differentiated or high grade carcinoma, or patients with neuroendocrine tumors not of bronchopulmonary origin; has been treated with peptide receptor radionuclide therapy (prrt) at any time prior to randomization; has been treated with more than two lines of cytotoxic chemotherapy or molecular targeted therapy or interferon for bronchopulmonary net.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Lanreotide and who got the comparison, which limits bias.

The Lanreotide group and the comparison group ran side by side rather than switching.

As a double-blind Lanreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2017-03-06 with completion listed for 2020-02-28.

It ran at 57 sites in United States (14), France (7), Canada (6), United Kingdom (6), Italy (5) and Poland (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Median Progression-Free Survival (PFS) Time in Subjects Randomised to Lanreotide in the Double-Blind Phase or Open-Label Treatment Phase, Assessed by Central Review (time frame: Up to a maximum of 33 months).

It also tracked 9 secondary outcomes, for example Median PFS Time in the Double-Blind Phase, Assessed by Central Review, Median PFS Time in the Double-Blind Phase, Assessed by Local Review, Objective Response Rate (ORR) in the Double-Blind Phase, Time to Treatment Failure (TTF) in the Double-Blind Phase, Mean Change From Baseline in the Biomarker Chromogranin A (CgA) in the Double-Blind Phase and Open-Label Treatment Phase and Percentage of Subjects Who Experienced QoL Deterioration.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lanreotide in 77 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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