Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)

What Was Tested

In this phase 3 trial, researchers set out to test 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: 484 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: Documented diagnosis of unresectable Stage III or Stage IV NSCLC. Patients may be receiving maintenance chemotherapy. Patients planning to initiate a new chemotherapy and/or radiation therapy regimen may do so only within ± 14 days of randomization. Body mass index ≤30 kg/m2. Life expectancy of \>4 months at time of screening.

The full record lists 13 inclusion and 15 exclusion criteria; among the exclusions: other forms of lung cancer (e.g., small cell, mesothelioma); women who are pregnant or breast-feeding; known hiv, hepatitis (b\&c), or active tuberculosis.

How the Study Was Run

The set-up was 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.

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 2014-01.

It ran at 60 sites in United States (12), Czechia (5), Ukraine (5), Belgium (4), Canada (4) and Germany (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Lean Body Mass (time frame: Change in Lean Body Mass from Baseline Over 12 Weeks). Change in Handgrip Strength (time frame: Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks).

It also tracked 3 secondary outcomes, for example Change in A/CS Domain Score, Change in FACIT-F Fatigue Domain Score and Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Anamorelin (non-peptide) in 484 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.