Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer

What Was Tested

The trial (phase 2, phase 3) is built around Anamorelin (non-peptide).

It had two arms (groups): Arm I (anamorelin hydrochloride) (experimental) and Arm II (placebo) (placebo comparator).

Patients receive anamorelin hydrochloride PO daily for 9 weeks in the absence of disease progression or unaccepted toxicity.

Patients receive placebo PO daily for 9 weeks in the absence of disease progression or unaccepted toxicity.

The registry classes the interventions as drug and other.

More on the Plan

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive anamorelin hydrochloride orally (PO) daily for 9 weeks in the absence of disease progression or unaccepted toxicity.

ARM II: Patients receive placebo PO daily for 9 weeks in the absence of disease progression or unaccepted toxicity.

Who Took Part

The registry lists 25 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: Presence of anorexia, defined as =\< 37 points on FAACT A/CS domain (on a 0 to 48-point scale in which 0 = worst possible anorexia/cachexia). Patients must be willing to keep a daily medication diary and engage in telephone follow up with research staff. Patients must have telephone access to allow contact by the research staff. Adequate hepatic function, defined as aspartate transaminase (AST) and alanine transaminase (ALT) levels =\< 5 x upper limit of normal (ULN). Life expectancy of \>= 6 months.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: major contraindication to anamorelin i.e. hypersensitivity; BMI \>= 28 kg/m\^2; inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.

How the Study Was Run

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

The participants were allocated by chance, so the Anamorelin (non-peptide) group and the comparison group should start out alike.

The Anamorelin (non-peptide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Anamorelin (non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2018-11-27 with completion listed for 2026-12-31.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

It also tracked 9 secondary outcomes, for example Explore any associations between changes in anorexia assessed by Patient Global Impression of Severity (PGIS) Scale and Explore any associations between changes in anorexia assessed by Patient Global Impression of Change (PGIC).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Anamorelin (non-peptide) in 25 people.

Its size is small, so on its own it can only give an early look.

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

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