Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)

What Was Tested

This registered phase 3 trial tested Anamorelin (non-peptide).

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

Placebo tablets identical in appearance to active tablets; oral administration once daily.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 513 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: ECOG performance status ≤2. Life expectancy of \>4 months at time of screening. Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: women who are pregnant or breast-feeding; inability to readily swallow oral tablets; patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded; has an active, uncontrolled infection.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Anamorelin (non-peptide) and who got the comparison, which limits bias.

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

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 2011-07 with completion listed for 2014-06.

It ran at 72 sites in United States (19), Poland (8), Belgium (5), Czechia (5), Australia (4) and Canada (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With Treatment-emergent Adverse Events (time frame: Over the 12-week treatment period).

It also tracked 3 secondary outcomes, for example Change in Body Weight, Change in Handgrip Strength of the Non-Dominant Hand and Change in A/CS Domain Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Anamorelin (non-peptide) in 513 people.

With 513 participants it is a large trial for this field.

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.