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A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - 1

14. september 2026 opdateret af: Helsinn Healthcare SA

Et fase 3 randomiseret, dobbeltblindt, placebokontrolleret, multicenter-studie for at evaluere effektiviteten og sikkerheden af ​​Anamorelin HCl til behandling af malignitetsassocieret vægttab og anoreksi hos voksne patienter med avanceret ikke-småcellet lungekræft (NSCLC)

The goal of this clinical trial was to compare the efficacy and safety of anamorelin HCl (the investigational drug) to that of placebo (tablet with no drug) in patients with advanced non-small cell lung cancer and cachexia (cancer-related weight loss). The main question it aimed to answer was as follows: Do patients who receive anamorelin HCl gain more body weight and show more improvement in anorexia symptoms than those who receive placebo.

Approximately 316 patients were to be enrolled in the study. Of these patients, an equal number were to be assigned to each treatment group (anamorelin HCl or placebo). Participants were to take their assigned study drug by mouth once daily for a total of 24 weeks. During this treatment period, the patients were to visit the clinical study site every 3 weeks for health and other study-related assessments. Two weeks after the last treatment, patients were to receive a follow-up phone call.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study was a multicenter, randomized, double-blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of anamorelin HCl. It was planned that approximately 316 patients with advanced NSCLC with cachexia were to be randomized 1:1 to anamorelin HCl 100 mg or placebo (158 patients per treatment group). The study treatment was to be taken orally once daily for a total of 24 weeks. Patients were instructed to take the study drug at least 1 hour before their first meal of the day.

Central randomization was stratified by line of systemic anti-cancer treatment (first line vs second line vs third line or higher), by type of anti-cancer therapy (immunotherapy vs non-immunotherapy), and by baseline score of the 5-item Anorexia Symptom Subscale (5-IASS) (≤10 vs >10).

Patients who had never received anti-cancer treatment prior to entering the study but who met all eligibility criteria were eligible to enter the study and were assigned to receive first line treatment in the Interactive Web Response System (IWRS).

Patients were to visit the site every 3 weeks for the study Treatment Period of 24 weeks. A follow-up telephone visit was to be scheduled at Week 26. Thus, patients were enrolled in the study for a maximum duration of 27 weeks (including a 1-week Screening Period, a 24-week Treatment Period, and a 2-week Follow-up Period). Each patient was scheduled to have a total of 10 planned visits plus 1 telephone contact for the Follow-up Visit.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

318

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Bulgarien
      • Dobrich, Bulgarien, 9300
        • Department of Medical Oncology, Multiprofile Hospital for Active Treatment - Dobrich, Dobrich
      • Gabrovo, Bulgarien, 5300
        • Department of Medical Oncology, Multiprofile Hospital for Active Treatment
    • Bulgaria
      • Varna, Bulgaria, Bulgarien, 9010
        • Clinic on Medical Oncology University Multiprofile Hospital for Active Treatment "Sveta Marina", Varna
    • Burgas
      • Burgas, Burgas, Bulgarien, 8000
        • Department of Medical Oncology, Complex Oncology Center - Burgas, Burgas
    • Sofia
      • Sofia, Sofia, Bulgarien, 1407
        • Department of Medical Oncology, Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, Sofia
    • Varna
      • Varna, Varna, Bulgarien, 9010
        • Clinic of Medical Oncology, Hospital Sveta Marina
  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85745
        • Chen
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • CARTI Cancer Center
    • California
      • Riverside, California, Forenede Stater, 92506
        • The Oncology Insitute of Hope and Innovation
    • Connecticut
      • Plainville, Connecticut, Forenede Stater, 06062
        • Hartford HealthCare Cancer Institute at the Hospital of Central Connecticut
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32204
        • 21st Century Oncology
      • Orange City, Florida, Forenede Stater, 32763
        • Mid Florida Hematology and Oncology Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Joliet, Illinois, Forenede Stater, 60435
        • Joliet Oncology Hematology Associates, Ltd
    • Indiana
      • Goshen, Indiana, Forenede Stater, 46526
        • Goshen Center for Cancer Care
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic, PC
      • Waterloo, Iowa, Forenede Stater, 50702
        • MercyOne Waterloo Cancer Center
    • Minnesota
      • Jackson, Minnesota, Forenede Stater, 39216
        • Jackson Oncology Associates, PLC
    • New Jersey
      • Elizabeth, New Jersey, Forenede Stater, 07207
        • Trinitas Comprehensive Cancer Center/Trinitas Regional Medical Center
      • Englewood, New Jersey, Forenede Stater, 07631
        • Englewood Health
    • New York
      • Johnson City, New York, Forenede Stater, 13790
        • Broome Oncology LLC
      • Lake Success, New York, Forenede Stater, 11042
        • Northwell Health
      • Stony Brook, New York, Forenede Stater, 11794
        • Stony Brook Cancer Center
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University Wexner Medical Center The James Cancer Hospital and Solove Research Institute
    • Pennsylvania
      • Gettysburg, Pennsylvania, Forenede Stater, 17325
        • Gettysburg Cancer Center
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Tennessee Cancer Specialist
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
        • Community Cancer Trial of Utah
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298-0230
        • Virginia Commonwealth University, Massey Cancer Center
    • Washington
      • Kennewick, Washington, Forenede Stater, 99336
        • Kadlec Clinic Hematology and Oncology
      • Wenatchee, Washington, Forenede Stater, 98801
        • Wenatchee Valley Hospital & Clinics
  • Italien
    • Ferrara
      • Cona, Ferrara, Italien, 44124
        • University Hospital of Ferrara, Oncology Department
    • Forli
      • Meldola, Forli, Italien, 47014
        • Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST)
    • Italia
      • Legnago, Italia, Italien, 37045
        • Hospital Mater Salutis
      • Lido di Camaiore, Italia, Italien, 55049
        • Versilia Hospital
      • Piacenza, Italia, Italien, 29121
        • Hospital "Guglielmo da Saliceto"
    • Italy
      • Aviano, Italy, Italien, 33081
        • Oncology Reference Center
      • Monza, Italy, Italien, 20900
        • Local Healthcare Company of Monza (ASST Monza)
      • Naples, Italy, Italien, 80131
        • AOU University Luigi Vanvitelli Oncohematology Department
      • Rome, Italy, Italien, 00168
        • University Policlinic Fondation Agostino Gemelli
    • Roma
      • Roma, Roma, Italien, 00185
        • Umberto I Policlinico la Sapienza, Translational and Precision Medicine Department
  • Rumænien
    • Bihor County
      • Oradea, Bihor County, Rumænien, 410469
        • S.C. Pelican Impex S.R.L
    • Cluj
      • Cluj-Napoca, Cluj, Rumænien, 400641
        • Medisprof S.R.L
    • Dolj
      • Craiova, Dolj, Rumænien, 200094
        • S.C. Onco Clinic Consult SA
    • Mureș County
      • Târgu Mureş, Mureș County, Rumænien, 540 141
        • Mures County Clinical Hospital
    • Prahova
      • Ploieşti, Prahova, Rumænien, 100337
        • Ploiesti Municipal Hospital
    • Timiș County
      • Timișoara, Timiș County, Rumænien, 300166
        • Oncocenter - Oncologie Clinica SRL
  • Rusland
      • Chelyabinsk, Rusland, 454048
        • Evimed, LLC
      • Ivanovo, Rusland, 153040
        • lvanovo Regional Oncology Center
      • Izhevsk, Rusland, 426009
        • Primushko Republicun Clinical Oncology Center
      • Kaliningrad, Rusland, 236016
        • Immanuel Kant Baltic Federal University
      • Kursk, Rusland, 305524
        • Kursk Regional Clinical Oncology Center
      • Moscow, Rusland, 121 309
        • YitaMed, LLC
      • Moscow, Rusland, 121467
        • University Headache Clinic
      • Omsk, Rusland, 644013
        • Clinical Oncology Center
      • Omsk, Rusland, 644046
        • Clinical Oncology Center
      • Saint Petersburg, Rusland, 197022
        • First I.P. Pavlov State Medical University of St. Petersburg
      • Saint Petersburg, Rusland, 198207
        • City Outpatient Clinic #43
      • Tambov, Rusland, 392013
        • Tambov Regional Oncological Clinical Center
      • Tomsk, Rusland, 634028
        • Tomsk National Research Medical Center
    • Kaluga Oblast
      • Obninsk, Kaluga Oblast, Rusland, 249036
        • National Medical Research Radiological Centre (Tsyb Medical Radiology Research Center)
  • Serbien
      • Belgrade, Serbien, 11000
        • Clinical Center of Serbia, Clinic of Pulmonology
      • Belgrade, Serbien, 11000
        • Clinical Hospital Center l\emnijsJca kosa
      • Belgrade, Serbien, 11000
        • Medical Military Academy
      • Belgrade, Serbien, 11000
        • Oncomed-System, Specialized Hospital for Internal Diseases
      • Kragujevac, Serbien, 34000
        • Clinical Center Kragujevac
  • Ungarn
      • Budapest, Ungarn, H-1121
        • Koranyi National Institute of Pulmonology, 6th Department of Pulmonology
      • Debrecen, Ungarn, H-4032
        • University of Debrecen Clinical Center, Department of Pulmonology
      • Farkasgyepű, Ungarn, 1-1-8582
        • Veszprem County Pulmonology Institute
      • Pécs, Ungarn, H-7623
        • Clinical Center of the University of Pecs, Department of Pulmonology
      • Szolnok, Ungarn, H-5000
        • Jasz-Nagy Kun-Szolnok County Hetenyi Geza Hospital-Clinic, Department of Oncology
      • Székesfehérvár, Ungarn, H-8000
        • Fejer County St. Gyorgy University Teaching Hospital, Pulmonology Department I
      • Törökbálint, Ungarn, H - 2045
        • Pulmonology Institute Torokbalint

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Signed written informed consent

  2. Female or male ≥18 years of age

  3. Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) Stage III or IV NSCLC. Stage III patient must have unresectable disease

  4. Body mass index < 20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening

  5. Ongoing problems with appetite/eating associated with the underlying cancer, as determined by having score of ≤ 17 points on the 5-item Anorexia Symptom Scale and ≤ 37 points on the 12-item FAACT A/CS

  6. Patient receiving or not receiving systemic anti-cancer treatment at the time of screening are eligible to participate. Systemic anti-cancer treatment includes first, second, third treatment line with chemotherapy/radiation therapy, immunotherapy or targeted therapy.

    Patient not receiving systemic anti-cancer treatment is eligible if:

    1. Not planning to receive anti-cancer treatment and/or at least 14 days must be elapsed from the completion of prior treatment at the day of screening, in case underwent previous cycle OR
    2. Planning to receive anti-cancer treatment within 14 days from randomization and/or at least 14 days must be elapsed from the completion of prior treatment at the day of screening, in case underwent previous cycle OR
    3. Patient on palliative care treatment

  7. ECOG performance status 0,1 or 2 at screening

  8. AST (SGOT) and ALT (SGPT) ≤ 3 x ULN or if hepatic metastases are present ≤ 5 x ULN

  9. Adequate renal function, defined as creatinine ≤2 ULN, or calculated creatinine clearance >30 ml/minute

  10. Female patient shall be: a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test within 24 hours prior to first dose of investigational product.

    Notes:

    1. Female patient of non-childbearing potential are defined as being in post-menopausal state since at least 1 year; or having documented surgical sterilization or hysterectomy at least 3 months before study participation.
    2. Reliable contraceptive measures include implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized partner or complete (long term) sexual abstinence.

  11. The patient must be willing and able to comply with the protocol tests and procedures.

All inclusion criteria were to be checked at screening visit (Visit 1). Inclusion criterion #10 was to be re-checked and verified at Day 1 (Visit 2).

Exclusion Criteria:

  1. Patient with other forms of lung cancer (e.g., small cell, neuroendocrine tumors)

  2. Woman who is pregnant or breast-feeding

  3. Reversible causes of reduced food intake, as determined by the Investigator. These causes may include but are not limited to:

    1. NCI CTCAE Grade 3 or 4 oral mucositis,
    2. NCI CTCAE Grade 3 or 4 GI disorders [nausea, vomiting, diarrhea, and constipation],
    3. mechanical obstructions making patient unable to eat, or
    4. severe depression

  4. Patient undergoing major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patient must be well recovered from acute effects of surgery prior to screening. Patient should not have plans to undergo major surgical procedures during the treatment period.

  5. Patient currently taking androgenic compounds including but not limited to testosterone, testosterone-like agents, oxandrolone; megestrol acetate; corticosteroids; olanzapine, mirtazapine (however, long-term use of mirtazapine for depression for at least four weeks prior to screening is allowed); dronabinol; marijuana (cannabis); or any other prescription medication or off-label products intended to increase appetite or treat unintentional weight loss

  6. Patient with pleural effusion requiring thoracentesis, pericardial effusion requiring drainage, edema or evidence of ascites

  7. Patient with uncontrolled or significant cardiovascular disease, including:

    1. History of myocardial infarction within the past 3 months
    2. A-V block of second or third degree (may be eligible if currently have a pacemaker)
    3. Unstable angina
    4. Congestive heart failure within the past 3 months, if defined as NYHA class III-IV
    5. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes)
    6. Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic)
    7. Heart rate < 50 beats per minute on pre-entry electrocardiogram and patient is symptomatic

  8. Patient on drugs that may prolong the PR or QRS interval durations, such as any of the antiarrhythmic medications Class I (Fast sodium (Na) channel blockers)

  9. Patient unable to readily swallow oral tablets

  10. Patient with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption)

  11. Patient with history of gastrectomy

  12. Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus

  13. Patient with cachexia caused by other reasons, as determined by the investigator such as:

    1. Severe COPD requiring use of home O2,
    2. New York Heart Association (NYHA) class III-IV heart failure
    3. AIDS
    4. Uncontrolled thyroid disease

  14. Patient receiving strong CYP3A4 inhibitors within 14 days of randomization

  15. Patient currently receiving tube feedings or parenteral nutrition (either total or partial).

  16. Current excessive alcohol or illicit drug use

  17. Any condition, including the presence of laboratory abnormalities, which in the Investigator's opinion, places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

  18. Enrollment in a previous study with anamorelin HCl

  19. Patient actively receiving a concurrent investigational agent, or having received an investigational agent within 28 days of Day 1

All exclusion criteria were to be checked at screening visit (Visit 1). Exclusion Criteria #3, 5, 6, 7g, and 9 were to be re-checked and verified before study drug administration (Visit 2).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 100 mg anamorelin HCl

100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Medicin: Anamorelin Hydrochloride

100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)
Placebo komparator: placebo

Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Medicin: Placebo Oral Tablet

Placebo (administered as matching placebo tablets in the fasted condition)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline in Body Weight Over 12 Weeks
Tidsramme: Mean change from baseline over 12 weeks.

This co-primary efficacy endpoint was mean change from baseline in body weight (kg) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.
Mean change from baseline over 12 weeks.
Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks
Tidsramme: Mean change from baseline over 12 weeks.

This co-primary efficacy endpoint was mean change from baseline in 5-IASS (points) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.

FAACT-A/CS (Functional Assessment Anorexia Cachexia Therapy) is a 12-item measure of patients' perceptions of anorexia/cachexia symptoms and concerns. From this questionnaire, the 5-item section referring to anorexia symptoms (i.e., "good appetite," "interest in food drops," "food tastes unpleasant," "get full quickly," and "difficulty eating rich/heavy foods") was used to assess 5-IASS. The range of possible scores is 0-20. Higher scores indicate lower levels of symptom burden.
Mean change from baseline over 12 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg)
Tidsramme: Duration of treatment benefit from baseline over 12 weeks.

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥0 kg.
Duration of treatment benefit from baseline over 12 weeks.
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg)
Tidsramme: Duration of treatment benefit from baseline over 12 weeks.

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥1.5 kg.
Duration of treatment benefit from baseline over 12 weeks.
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points)
Tidsramme: Duration of treatment benefit from baseline over 12 weeks.

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5-IASS of ≥0 points.
Duration of treatment benefit from baseline over 12 weeks.
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points)
Tidsramme: Duration of treatment benefit from baseline over 12 weeks.

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5-IASS of ≥3 points.
Duration of treatment benefit from baseline over 12 weeks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Helsinn Healthcare SA

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. marts 2019

Primær færdiggørelse (Faktiske)

11. februar 2023

Studieafslutning (Faktiske)

11. februar 2023

Datoer for studieregistrering

Først indsendt

14. november 2018

Først indsendt, der opfyldte QC-kriterier

14. november 2018

Først opslået (Faktiske)

15. november 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. juni 2024

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ANAM-17-20
  • 2018 (U.S. NIH-bevilling/kontrakt)
  • 2018-002926-22 (EudraCT nummer)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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