Trial · NCT01395914

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

NCT01395914, Phase 3, Completed, Helsinn Therapeutics (U.S.), Inc; results first posted 2017-07-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3). Trials, record NCT01395914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01395914

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
NCT number: NCT01395914
Status: Completed
Phases: Phase 3
Enrollment: 513 participants, actual
Lead sponsor: Helsinn Therapeutics (U.S.), Inc
Conditions: Cachexia, Non-Small Cell Lung Cancer
Interventions: Anamorelin HCl, Placebo
First posted: 2011-07-18
Last updated: 2017-09-14
Results first posted: 2017-07-11

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Treatment-emergent Adverse Events	Over the 12-week treatment period	To Evaluate the Safety and Tolerability of Anamorelin HCl.
Secondary	Change in Body Weight	Change in body weight from baseline of the original trial through Week 12 of this extension trial.
Secondary	Change in Handgrip Strength of the Non-Dominant Hand	Change in HGS from baseline of the original trial through Week 12 of this extension trial.
Secondary	Change in A/CS Domain Score	Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial	Change in the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) 12-item Additional Concerns Subscale (A/CS) domain score is a 12-item scale. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best).

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Treatment-emergent Adverse Events	Over the 12-week treatment period	Safety Population, defined as patients who received any extension trial study drug.	percentage of participants	NUMBER
SECONDARY	Change in Body Weight	Change in body weight from baseline of the original trial through Week 12 of this extension trial.	Intent-to-Treat Population	kg	LEAST_SQUARES_MEAN
SECONDARY	Change in Handgrip Strength of the Non-Dominant Hand	Change in HGS from baseline of the original trial through Week 12 of this extension trial.	Intent-to-Treat Population	kg	LEAST_SQUARES_MEAN
SECONDARY	Change in A/CS Domain Score	Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial		scores on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With Treatment-emergent Adverse Events	Anamorelin HCl	52		percentage of participants
Percentage of Participants With Treatment-emergent Adverse Events	Placebo	56		percentage of participants
Change in Body Weight	Anamorelin HCl	3.06	Standard Error 0.631	kg
Change in Body Weight	Placebo	0.92	Standard Error 0.697	kg
Change in Handgrip Strength of the Non-Dominant Hand	Anamorelin HCl	-0.83	Standard Error 0.929	kg
Change in Handgrip Strength of the Non-Dominant Hand	Placebo	-0.55	Standard Error 1.036	kg
Change in A/CS Domain Score	Anamorelin HCl	4.46	Standard Error 0.92	scores on a scale
Change in A/CS Domain Score	Placebo	3.24	Standard Error 1.01	scores on a scale

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Anamorelin HCl	345
Overall Study	STARTED	Placebo	168
Overall Study	ITT Population	Anamorelin HCl	345
Overall Study	ITT Population	Placebo	168
Overall Study	Safety Population	Anamorelin HCl	343
Overall Study	Safety Population	Placebo	167
Overall Study	COMPLETED	Anamorelin HCl	273
Overall Study	COMPLETED	Placebo	131
Overall Study	NOT COMPLETED	Anamorelin HCl	72
Overall Study	NOT COMPLETED	Placebo	37

Source ClinicalTrials.gov

Adverse events72

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Anamorelin HCl	45	343	56
other	Anaemia	Blood and lymphatic system disorders	Placebo	25	167	37
other	Neutropenia	Blood and lymphatic system disorders	Anamorelin HCl	18	343	21
other	Neutropenia	Blood and lymphatic system disorders	Placebo	8	167	8
other	Asthenia	General disorders	Anamorelin HCl	19	343	20
other	Asthenia	General disorders	Placebo	14	167	14
other	Decreased appetite	Metabolism and nutrition disorders	Anamorelin HCl	12	343	13
other	Decreased appetite	Metabolism and nutrition disorders	Placebo	10	167	10
serious	Splenic rupture	Injury, poisoning and procedural complications	Anamorelin HCl	1	343	1
serious	Splenic rupture	Injury, poisoning and procedural complications	Placebo	0	167	0

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Anamorelin HCl
Total, all-cause mortality	Placebo
Total, other adverse events	Anamorelin HCl	94	343
Total, other adverse events	Placebo	57	167
Total, serious adverse events	Anamorelin HCl	44	343
Total, serious adverse events	Placebo	21	167

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28472437	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Anamorelin HCl vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01395914

GET https://conductscience.org/api/trials/v1/NCT01395914/events?page=2

API reference For AI assistants