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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 сентября 2026 г. обновлено: Helsinn Healthcare SA

Рандомизированное, двойное слепое, плацебо-контролируемое, многоцентровое исследование фазы 3 по оценке эффективности и безопасности анаморелина гидрохлорида для лечения связанной со злокачественными новообразованиями потери веса и анорексии у взрослых пациентов с распространенным немелкоклеточным раком легкого (НМРЛ)

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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

318

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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).

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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
Лекарство: Anamorelin Hydrochloride

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

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

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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mean Change From Baseline in Body Weight Over 12 Weeks
Временное ограничение: 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
Временное ограничение: 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.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Helsinn Healthcare SA

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

5 марта 2019 г.

Первичное завершение (Действительный)

11 февраля 2023 г.

Завершение исследования (Действительный)

11 февраля 2023 г.

Даты регистрации исследования

Первый отправленный

14 ноября 2018 г.

Впервые представлено, что соответствует критериям контроля качества

14 ноября 2018 г.

Первый опубликованный (Действительный)

15 ноября 2018 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

6 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

14 сентября 2026 г.

Последняя проверка

1 июня 2024 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • ANAM-17-20
  • 2018 (Грант/контракт NIH США)
  • 2018-002926-22 (Номер EudraCT)

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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