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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 września 2026 zaktualizowane przez: Helsinn Healthcare SA

Randomizowane, podwójnie ślepe, kontrolowane placebo, wieloośrodkowe badanie fazy 3 oceniające skuteczność i bezpieczeństwo chlorowodorku anamoreliny w leczeniu utraty masy ciała i anoreksji związanej z chorobą nowotworową u dorosłych pacjentów z zaawansowanym niedrobnokomórkowym rakiem płuca (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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

318

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Lek: Anamorelin Hydrochloride

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

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

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Change From Baseline in Body Weight Over 12 Weeks
Ramy czasowe: 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
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Helsinn Healthcare SA

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

5 marca 2019

Zakończenie podstawowe (Rzeczywisty)

11 lutego 2023

Ukończenie studiów (Rzeczywisty)

11 lutego 2023

Daty rejestracji na studia

Pierwszy przesłany

14 listopada 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 listopada 2018

Pierwszy wysłany (Rzeczywisty)

15 listopada 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 września 2026

Ostatnia weryfikacja

1 czerwca 2024

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ANAM-17-20
  • 2018 (Grant/umowa NIH USA)
  • 2018-002926-22 (Numer EudraCT)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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