CachexiaPhase 3NCT01387282

Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)

A Phase 3 study testing Anamorelin HCl in people with Cachexia and Non-Small Cell Lung Cancer, run by Helsinn Therapeutics (U.S.), Inc at 46 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cachexia, Non-Small Cell Lung Cancer
What is being tested?: Anamorelin HCl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 495 participants
Where: 46 sitesin 7 countries
Study dates: Jul 2011to Feb 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to 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
Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization; at least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization
Involuntary weight loss of ≥5% body weight within 6 months prior to screening or a screening body mass index (BMI) <20 kg/m2
Body mass index ≤30 kg/m2

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Life expectancy of >4 months at time of screening
ECOG performance status ≤2
Adequate hepatic function, defined as AST and ALT levels ≤5 x upper limit of normal
Adequate renal function, defined as creatinine ≤2 x upper limit of normal, or calculated creatinine clearance >30 ml/minute
Ability to understand and comply with the procedures for the HGS evaluation
If a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method)
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

Who cannot join

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
Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period
Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol
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

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Has an active, uncontrolled infection
Has uncontrolled diabetes mellitus
Has untreated clinically relevant hypothyroidism
Has known or symptomatic brain metastases
Receiving strong CYP3A4 inhibitors within 14 days of randomization
Receiving tube feedings or parenteral nutrition (either total or partial); patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration
Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation
Has had previous exposure to Anamorelin HCl
Patients actively receiving a concurrent investigational agent

Trial locations and contacts

46 sites in 7 countries.

Country

City, postcode or hospital

46 sites in 7 countries

United States14 sites

Study site
Baltimore, Maryland
Study site
Charleston, South Carolina
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Corona, California
Study site
Detroit, Michigan
Study site
Durham, North Carolina
Study site
Falls Church, Virginia
Study site
Fountain Valley, California
Study site
Glendale, California
Study site
Lake Success, New York
Study site
Sylvania, Ohio
Study site
Washington D.C., District of Columbia
Study site
West Reading, Pennsylvania

Other trials in United States

Israel8 sites

Study site
Beersheba
Study site
Haifa
Study site
Jerusalem
Study site
Kfar Saba
Study site
Petach Tikvah
Study site
Tel Aviv
Study site
Tel HaShomer
Study site
Tsrifin

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Poland8 sites

Study site
Bydgoszcz
Study site
Grudziądz
Study site
Katowice
Study site
Krakow
Study site
Lodz
Study site
Lublin
Study site
Szczecin
Study site
Warsaw

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Hungary5 sites

Study site
Budapest
Study site
Nyíregyháza
Study site
Székesfehérvár
Study site
Szikszó
Study site
Törökbálint

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Russia5 sites

Study site
Krasnodar
Study site
Moscow
Study site
Novosibirsk
Study site
Saint Petersburg
Study site
Yekaterinburg

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Australia4 sites

Study site
Adelaide
Study site
East Bentleigh, Victoria
Study site
Parkville, Victoria
Study site
Prairiewood, New South Wales

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United Kingdom2 sites

Study site
Leicester
Study site
Middlesex

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About this study

Official title: 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

The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function.

Conditions: Cachexia, Non-Small Cell Lung Cancer
Being tested: Anamorelin HCl, Placebo
Medical subject headings: Cachexia, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anamorelin HClDrug
Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal
PlaceboDrug
Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.

Study groups in NCT01387282
Study group	Role	What they receive
100 mg QD	Active comparator	Investigational: Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day. Receives: Drug: Anamorelin HCl
Placebo	Placebo comparator	Placebo tablets identical in appearance to active tablets; oral administration once daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Lean Body Mass
Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
Measured: Change in Lean Body Mass from Baseline Over 12 Weeks
Change in Handgrip Strength
Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
Measured: Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks

Secondary outcomes (3)

Change in A/CS Domain Score
The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. 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).
Measured: Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks
Change in FACIT-F Fatigue Domain Score
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
The 13-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 FACIT-F fatigue domain ranges from 0 (worst) to 52 (best).
Measured: Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks
Change in Body Weight
Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.
Measured: Change in Body Weight from Baseline Over 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Feb 2015

First posted4 Jul 2011 (estimated)
Study startJul 2011
Primary completionNov 2013
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for CachexiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 495 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01387282
Sponsor's protocol ID: HT-ANAM-302
Status last verified: Sep 2017
First submitted: 30 Jun 2011
Last updated: 27 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Laird BJA, Skipworth R, Bonomi PD, Fallon M, Kaasa S, Giorgino R, McMillan DC, Currow DC. Anamorelin Efficacy in Non-Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13732. doi: 10.1002/jcsm.13732.
PubMed 39992021
Currow D, Temel JS, Abernethy A, Milanowski J, Friend J, Fearon KC. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. 2017 Aug 1;28(8):1949-1956. doi: 10.1093/annonc/mdx192.
PubMed 28472437
Temel JS, Abernethy AP, Currow DC, Friend J, Duus EM, Yan Y, Fearon KC. Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials. Lancet Oncol. 2016 Apr;17(4):519-531. doi: 10.1016/S1470-2045(15)00558-6. Epub 2016 Feb 20.
PubMed 26906526
Salsman JM, Beaumont JL, Wortman K, Yan Y, Friend J, Cella D. Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia. Support Care Cancer. 2015 May;23(5):1355-64. doi: 10.1007/s00520-014-2484-9. Epub 2014 Oct 29.
PubMed 25351456

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01387282
Acronym / sponsor ID: HT-ANAM-302
Conditions: Cachexia, Non-Small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 495 participants (actual)
Lead sponsor: Helsinn Therapeutics (U.S.), IncIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Nov 2013 (actual)
Study completion: Feb 2015 (actual)
First posted: 4 Jul 2011 (estimated)
Results: Posted 11 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
100 mg QD	Active comparator	Drug: Anamorelin HClInvestigational: Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablets identical in appearance to active tablets; oral administration once daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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
Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization; at least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization
Involuntary weight loss of ≥5% body weight within 6 months prior to screening or a screening body mass index (BMI) <20 kg/m2

Key exclusion criteria (15 listed)

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
Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period
Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anamorelin HClAnamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal	Drug	100 mg QD
PlaceboPlacebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.	Drug	Placebo

Primary outcome

Change in Lean Body Mass
Time frame: Change in Lean Body Mass from Baseline Over 12 Weeks
Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
Change in Handgrip Strength
Time frame: Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks
Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.

3 secondary outcomes

Change in A/CS Domain Score
Time frame: Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks
Change in FACIT-F Fatigue Domain Score
Time frame: Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks
Change in Body Weight
Time frame: Change in Body Weight from Baseline Over 12 Weeks

Results and safety

Results posted to the registry on 11 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anamorelin HCl	330	233
Placebo	165	118

Primary outcome: Change in Lean Body Mass

Time frame: Change in Lean Body Mass from Baseline Over 12 Weeks. Median (95% Confidence Interval). Unit: kg

Measure	Anamorelin HCl n = 321	Placebo n = 157
Value	0.65 (0.38 to 0.91)	-0.98 (-1.49 to -0.41)

Anamorelin HCl vs Placebo: p < 0.0001, Wilcoxon rank sum test

Population analysed: Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.

Primary outcome: Change in Handgrip Strength

Time frame: Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks. Median (95% Confidence Interval). Unit: kg

Measure	Anamorelin HCl n = 321	Placebo n = 157
Value	-1.49 (-2.06 to -0.58)	-0.95 (-1.56 to 0.04)

Anamorelin HCl vs Placebo: p = 0.6480, Wilcoxon rank sum test

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events that occurred during the clinical trial, commenced with the first dose of study drug through the 28 day post-treatment follow-up visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anamorelin HCl	73 of 330 (22.1%)	156 of 330 (47.3%)	Not reported
Placebo	27 of 161 (16.8%)	72 of 161 (44.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39992021Laird BJA, Skipworth R, Bonomi PD, Fallon M, Kaasa S, Giorgino R, McMillan DC, Currow DC. Anamorelin Efficacy in Non-Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13732. doi: 10.1002/jcsm.13732.
Derived from this study: PubMed 28472437Currow D, Temel JS, Abernethy A, Milanowski J, Friend J, Fearon KC. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. 2017 Aug 1;28(8):1949-1956. doi: 10.1093/annonc/mdx192.
Derived from this study: PubMed 26906526Temel JS, Abernethy AP, Currow DC, Friend J, Duus EM, Yan Y, Fearon KC. Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials. Lancet Oncol. 2016 Apr;17(4):519-531. doi: 10.1016/S1470-2045(15)00558-6. Epub 2016 Feb 20.
Derived from this study: PubMed 25351456Salsman JM, Beaumont JL, Wortman K, Yan Y, Friend J, Cella D. Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia. Support Care Cancer. 2015 May;23(5):1355-64. doi: 10.1007/s00520-014-2484-9. Epub 2014 Oct 29.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

46 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anamorelin HCl in people with Cachexia and Non-Small Cell Lung Cancer, run by Helsinn Therapeutics (U.S.), Inc at 46 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Israel, Poland, Hungary, Russia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lean Body Mass (time frame: Change in Lean Body Mass from Baseline Over 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01387282, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.