3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial

What Was Tested

The trial (phase 2) is built around Pasireotide.

This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma of the lung and thymus.

It had three arms (groups): Pasireotide LAR (experimental), Everolimus (experimental) and Pasireotide LAR and Everolimus Combination (experimental).

The registry classes the interventions as drug.

More on the Plan

This was a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a single-stage design in each arm.

It was expected that a total of 120 patients with 40 patients in each arm were to be enrolled into this study.

Patients were seen weekly for one month and monthly thereafter.

Radiological and biochemical response assessments were performed every 3 months.

Who Took Part

124 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: Histological confirmed advanced well differentiated typical and atypical carcinoid tumors of the lung or thymus. Patients of all treatment lines including naive patients could have been enrolled. At least one measurable lesion of disease on CT scan or MRI. Radiological documentation of disease progression within 12 months prior to randomization. Adequate liver, renal and bone marrow function.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: poorly differentiated neuroendocrine carcinoma; non-neuroendocrine thymoma; patients with severe functional disease who required symptomatic treatment with somatostatin analogs.

How the Study Was Run

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

Because people in this Pasireotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-08-16 with completion listed for 2020-02-10.

It ran at 36 sites in Italy (10), France (7), Spain (6), United Kingdom (4), Germany (3) and Denmark (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) (time frame: Baseline up to 9 months).

It also tracked 11 secondary outcomes, for example Summary of Progression-free Survival (PFS) Based on RECIST v1.1, Kaplan-Meier Estimates of Progression-free Survival (PFS), Summary of Time to Response (Months), Summary of Duration of Response (Months), 12-month Disease Control Rate (DCR) and Objective Response Rate (ORR) and Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pasireotide in 124 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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