A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - 2

What Was Tested

In this phase 3 trial, researchers set out to test Anamorelin (non-peptide).

Approximately 316 patients were to be enrolled in the study.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks.

The registry classes the interventions as drug.

More on the Plan

The study treatment was to be taken orally once daily for a total of 24 weeks.

Patients were instructed to take the study drug at least 1 hour before their first meal of the day.

Central randomization was stratified by line of systemic anti-cancer treatment (first line vs second line vs third line or higher), by type of anti-cancer therapy (immunotherapy vs non-immunotherapy), and by baseline score of 5 IASS (≤10 vs \>10).

Patients who had never received anti-cancer treatment prior to entering the study but who met all eligibility criteria were eligible to enter the study and were assigned to receive first line treatment in the Interactive Web Response System (IWRS).

Who Took Part

318 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: Signed written informed consent. Female or male ≥18 years of age. Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) Stage III or IV NSCLC. Stage III patient must have unresectable disease. Patient on palliative care treatment. ECOG performance status 0,1 or 2 at screening.

The full record lists 16 inclusion and 34 exclusion criteria; among the exclusions: patient with other forms of lung cancer (e.g., small cell, neuroendocrine tumors); woman who is pregnant or breast-feeding; NCI CTCAE Grade 3 or 4 oral mucositis,.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Anamorelin (non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Anamorelin (non-peptide).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-05-06 with completion listed for 2022-12-27.

It ran at 65 sites in United States (19), Russia (10), Ukraine (8), Poland (7), Romania (7) and Australia (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Change From Baseline in Body Weight Over 12 Weeks (time frame: Mean change from baseline over 12 weeks). Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks (time frame: Mean change from baseline over 12 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Anamorelin (non-peptide) in 318 people.

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

More context: the Anamorelin (non-peptide) compound page, all human trials.