Evidence map›Paper›PMID 39992021›Full record

Trial reportJournal of cachexia, sarcopenia and muscle2025

Anamorelin Efficacy in Non-Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2.

Barry J A Laird, Richard Skipworth, Philip D Bonomi, Marie Fallon, Stein Kaasa, Ruben Giorgino, Donald C McMillan, David C Currow

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of cachexia, sarcopenia and muscle, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01387269 phase3completednot on this map

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

TypeinterventionalSponsorHelsinn Therapeutics (U.S.), IncRan2011 to 2015Enrolled484ConditionsCachexia, Non-Small Cell Lung CancerArmsAnamorelin HCl, Placebo
NCT01387282 phase3completednot on this map

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

TypeinterventionalSponsorHelsinn Therapeutics (U.S.), IncRan2011 to 2015Enrolled495ConditionsCachexia, Non-Small Cell Lung CancerArmsAnamorelin HCl, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Effect of anamorelin on body weight in patients with gastric cancer-associated cachexia: an observational study.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
    Observational
  9. Review
  10. Review
  11. Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Barry J A LairdInstitute of Genetics and Cancer, University of Edinburgh, Western General Hospital, Edinburgh, UK.ORCID 0000-0002-2807-6192
Richard SkipworthClinical Surgery, Royal Infirmary of Edinburgh, University of Edinburgh, Edinburgh, UK.
Philip D BonomiDepartment of Internal Medicine, Rush University Medical Center, Chicago, Illinois, USA.
Marie FallonInstitute of Genetics and Cancer, University of Edinburgh, Western General Hospital, Edinburgh, UK.
Stein KaasaDepartment of Oncology, Oslo University Hospital and University of Oslo, Oslo, Norway.
Ruben GiorginoFormerly of Research and Development Innovation and Strategy Department, Helsinn Healthcare SA, Lugano, Switzerland.
Donald C McMillanAcademic Unit of Surgery, School of Medicine, University of Glasgow, Glasgow, UK.
David C CurrowFaculty of Science, Medicine and Health, University of Wollongong, Wollongong, Australia.

Funding

Helsinn Therapeutics (US) Inc.
6 · The paper itself

Abstract

backgroundCancer cachexia presents a significant challenge, but the ghrelin agonist anamorelin shows promise as a potential treatment. This study examined whether the baseline systemic inflammatory response (SIR) (measured by the modified Glasgow Prognostic Score [mGPS]), low BMI or greater weight loss, was associated with a differential treatment effect of anamorelin in people with cachexia and non-small-cell lung cancer (NSCLC).

methodsROMANA 1 and ROMANA 2 were double-blind, placebo-controlled, randomised Phase 3 trials that enrolled people with inoperable stage III/IV NSCLC with cachexia (≥ 5% weight loss within 6 months or body mass index [BMI] < 20 kg/m

resultsSeven hundred ninety-five patients had available data. Anamorelin improved body weight (p < 0.001) and body composition parameters (LBM and FM, p < 0.01) in all mGPS groups. In patients with mGPS = 2, anamorelin increased weight > 5% and improved hand grip strength (HGS) and the Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT A/CS). In patients with BMI < 20 kg/m

conclusionAnamorelin improved body composition parameters in all patients, as well as physical function and symptom burden, particularly in patients with systemic inflammation, BMI < 20 kg/m

trial registrationNCT identifiers: ROMANA 1: NCT01387269; ROMANA 2: NCT01387282.

Indexed as

CachexiaCarcinoma, Non-Small-Cell LungHydrazinesLung NeoplasmsOligopeptidesAgedBody CompositionBody Mass IndexDouble-Blind MethodFemaleHumansMaleMiddle AgedReceptors, GhrelinTreatment OutcomeanamorelinHydrazinesOligopeptidesReceptors, Ghrelincachexiacancermodified Glasgow Prognostic ScoreROMANA 1ROMANA 2systemic inflammatory responsetrials

Identifiers

PMID39992021
PMCPMC11848863

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.