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BMS-986489 (атиготатуг + ниволумаб) в сравнении с дурвалумабом при мелкоклеточном раке легких ограниченной стадии (TIGOS-LS) (TIGOS-LS)

16 сентября 2026 г. обновлено: SCRI Development Innovations, LLC

Открытое рандомизированное исследование BMS-986489 (комбинация фиксированных доз атиготатуг + ниволумаб) по сравнению с дурвалумабом в качестве консолидационной терапии после химиолучевой терапии при мелкоклеточном раке легких ограниченной стадии (TIGOS-LS)

This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab in limited-stage (LS)-small-cell lung cancer (SCLC) participants.

The main goals of this study are to:

  • Evaluate the efficacy of BMS-986489 vs durvalumab
  • Evaluate the safety profile of BMS-986489

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Подробное описание

This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab as consolidation therapy following chemoradiotherapy in participants with limited-stage (LS)-small-cell lung cancer (SCLC). Participants will receive concurrent chemotherapy and radiotherapy according to standard guidelines for treatment of LS-SCLC without progressive disease prior to randomization. Eligible participants will be randomly assigned to receive either BMS-986489 (atigotatug + nivolumab as a fixed-dose combination; Arm A) or durvalumab (Arm B) as consolidation therapy. Atigotatug is a first-in-class, fully human IgG1 antibody being developed for the treatment of SCLC. Atigotatug specifically binds to fuc-GM1 on the tumor cell. Nivolumab is a monoclonal anti-PD-1 antibody. Combining atigotatug with another immunotherapy may provide enhanced antitumor effects.

Тип исследования

Интервенционный

Регистрация (Оцененный)

250

Фаза

  • Фаза 2

Контакты и местонахождение

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

Места учебы

  • Соединенные Штаты
    • Alabama
      • Daphne, Alabama, Соединенные Штаты, 36526
        • Southern Cancer Center
    • California
      • Santa Barbara, California, Соединенные Штаты, 93105
        • Sansum Clinic
    • Florida
      • Fort Myers, Florida, Соединенные Штаты, 33901
        • Florida Cancer Specialists - South
      • Miami, Florida, Соединенные Штаты, 33136
        • University of Miami - Sylvester Cancer Center
      • Ocala, Florida, Соединенные Штаты, 34474
        • Ocala Oncology Center
      • Orange City, Florida, Соединенные Штаты, 32763
        • Florida Cancer Specialists - North
      • Palm Bay, Florida, Соединенные Штаты, 32901
        • Cancer Care Centers of Brevard
      • West Palm Beach, Florida, Соединенные Штаты, 33401
        • Florida Cancer Specialists - East
    • Georgia
      • Atlanta, Georgia, Соединенные Штаты, 30309
        • Piedmont Healthcare - Atlanta
    • Illinois
      • Arlington Heights, Illinois, Соединенные Штаты, 60005
        • Illinois Cancer Specialists
      • Peoria, Illinois, Соединенные Штаты, 61615
        • Illinois Cancer Care
    • Indiana
      • Indianapolis, Indiana, Соединенные Штаты, 46202
        • Indiana University Simon Cancer Center
    • Kentucky
      • Corbin, Kentucky, Соединенные Штаты, 40701
        • Baptist Health - Corbin
      • Lexington, Kentucky, Соединенные Штаты, 40503
        • Baptist Health - Lexington
      • Louisville, Kentucky, Соединенные Штаты, 40207
        • Baptist Health - Louisville
    • Minnesota
      • Maple Grove, Minnesota, Соединенные Штаты, 55369
        • Minnesota Oncology Hematology
    • Missouri
      • Columbia, Missouri, Соединенные Штаты, 65201
        • Missouri Cancer Associates
    • New York
      • White Plains, New York, Соединенные Штаты, 10601
        • White Plains Hospital Physician Associates
    • North Carolina
      • Wilson, North Carolina, Соединенные Штаты, 27896
        • Carolina Cancer Research Center
    • Ohio
      • Cincinnati, Ohio, Соединенные Штаты, 45242
        • Oncology Hematology Care
      • Columbus, Ohio, Соединенные Штаты, 43210
        • The Ohio State University - Arthur James Cancer Hospital & Solove Research Institute
      • Columbus, Ohio, Соединенные Штаты, 43219
        • Mid Ohio Hem/ Onc dba The Mark H Zangmeister Center
    • Oregon
      • Eugene, Oregon, Соединенные Штаты, 97401
        • Oncology Associates of Oregon (Willamette Valley Cancer Institute and Research Center)
    • Tennessee
      • Knoxville, Tennessee, Соединенные Штаты, 37909
        • Tennessee Cancer Specialists
      • Nashville, Tennessee, Соединенные Штаты, 37203
        • SCRI Oncology Partners
    • Texas
      • Amarillo, Texas, Соединенные Штаты, 79124
        • Texas Oncology - West Texas
      • Austin, Texas, Соединенные Штаты, 78705
        • Texas Oncology- Austin
      • Beaumont, Texas, Соединенные Штаты, 77702
        • Texas Oncology - Gulf Coast
      • Dallas, Texas, Соединенные Штаты, 75246
        • Texas Oncology - DFW
      • Denison, Texas, Соединенные Штаты, 75020
        • Texas Oncology - Northeast Texas
      • San Antonio, Texas, Соединенные Штаты, 78240
        • Texas Oncology - San Antonio
    • Virginia
      • Fairfax, Virginia, Соединенные Штаты, 22031
        • Virginia Cancer Specialists
      • Norfolk, Virginia, Соединенные Штаты, 23502
        • Virginia Oncology Associates
      • Salem, Virginia, Соединенные Штаты, 24153
        • Blue Ridge Cancer Center (Oncology & Hematology Associates of Southwest VA)

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:

  • At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix A)

  • Histologically or cytologically confirmed pulmonary SCLC, evaluable by RECIST v1.1

  • Limited-stage (LS) disease as determined by positron emission tomography (PET) scan prior to initiation of chemotherapy and radiation therapy

  • Completed concurrent chemotherapy and radiotherapy for LS-SCLC without progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (computed tomography [CT] scan chest/abdomen/pelvis; Appendix B) within 42 days before date of randomization and first dose of study treatment

    • Chemotherapy should consist of a platinum and IV etoposide. Participants who received at least 3 cycles of chemotherapy will be eligible to participate.
    • Radiotherapy should be administered per institutional guidelines

  • Prophylactic cranial irradiation (PCI) may be delivered at the discretion of the Investigator and institutional guidelines. PCI, if applicable, must be conducted after the end of chemoradiotherapy and completed between 14 and 42 days before date of randomization and first dose of study treatment.

  • Adequate hematologic and organ function

  • Willingness to abide by protocol defined contraceptive requirements for the duration of the study.

Exclusion Criteria:

  • Small-cell cancer not pulmonary in origin

  • Large cell neuroendocrine carcinoma

  • ES-SCLC

  • Mixed SCLC and NSCLC histologic features; diagnosis of NSCLC; or EGFR-activating, mutation-positive NSCLC that has transformed to SCLC

  • History of severe hypersensitivity reaction to monoclonal antibodies

  • Known hypersensitivity to any excipients of atigotatug, nivolumab, or durvalumab

  • Grade ≥2 peripheral neuropathy by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  • Active, prior, or suspected autoimmune disease, including autoimmune neurologic disorders such as paraneoplastic syndrome involving the CNS, peripheral sensory/motor nerves, or neuromuscular junction. Exceptions to this criterion include:

    • Type 1 diabetes mellitus
    • Hypothyroidism requiring only hormone replacement
    • Skin disorders not requiring systemic treatment
    • Autoimmune conditions not expected to recur during the study

  • Diseases or conditions requiring chronic systemic corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive therapy within 14 days of starting study treatment. Limited-course (<2 weeks' duration) oral steroids (10 mg prednisone or equivalent) are permitted. Bronchodilators, inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.

  • History of solid organ or bone marrow transplantation

  • History of Grade ≥2 pneumonitis (excepting resolved infective pneumonitis)

  • Any of the following cardiac criteria, currently or within the last 3 months:

    • Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block, atrial fibrillation not rate controlled. Certain conditions may be considered through discussion with the Medical Monitor.
    • Congestive heart failure (New York Heart Association [NYHA] > Grade 2) or classified as Class 3 or 4 by the NYHA Functional Classification (Appendix D)
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, uncontrolled hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval (Appendix E). Certain conditions may be considered through discussion with the Medical Monitor.
    • Participants with a left ventricular ejection fraction <55% or the lower limit of normal of the institutional standard
    • Uncontrolled hypertension, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management
    • Active coronary artery disease, including unstable or newly diagnosed angina
    • Myocardial infarction
    • History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes)
    • History or current diagnosis of myocarditis

  • As judged by the Investigator, participants with serious or uncontrolled medical disorders

  • Presence of other active invasive cancers. Participants with a previously treated malignancy will be eligible to participate if treatment of that malignancy was completed at least 2 years before date of screening and the participants has no evidence of disease. Exceptions to this criterion include appropriately treated basal cell carcinoma of the skin; in situ carcinoma of uterine cervix; localized prostate cancer that has been definitively treated; or other local tumors considered cured by local treatment.

  • Received sequential chemotherapy and radiotherapy as a definitive treatment for LS-SCLC

  • Treatment with any of the following:

    • Any systemic anticancer chemotherapy, small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment
    • Wide-field radiotherapy (including therapeutic radioisotopes such as strontium-89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study treatment or has not recovered from side effects of such therapy
    • Prior systemic treatment for LS-SCLC, with the exception of chemoradiotherapy and PCI
    • Prior treatment with an anti-PD-1, anti-PD-L1, anti-programmed cell death ligand 2 (anti-PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
    • Prior treatment with fuc-GM-1 vaccine or targeted agent or similar vaccine targeting ganglioside antigens
    • Current treatment with immunosuppressive medications
    • Live attenuated vaccine within 100 days before first dose of study treatment

  • Major surgery (excluding placement of vascular access) within 4 weeks of date of screening

  • With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment. Note: Participants with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor or Principal Investigator.

  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol

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: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: BMS-986489 (atigotatug + nivolumab)

Participants will receive a fixed dose of BMS-986489 (atigotatug + nivolumab) intravenously each cycle. Cycles will be 28 days. Up to 125 participants will be enrolled into this arm.
Лекарство: BMS-986489

BMS-986489 (fixed dose combination of atigotatug + nivolumab) will be administered as an intravenous infusion to be given once every 4 weeks for up to 2 years.
Активный компаратор: Durvalumab

Participants will receive standard of care Durvalumab intravenously each cycle. Cycles will be 28 days. Up to 125 participants will be enrolled into this arm.
Лекарство: Durvalumab

Durvalumab will be administered as a fixed dose intravenous infusion to be given once every 4 weeks for up to 2 years.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS).
Временное ограничение: From date of randomization up to 5 years. Every 8 weeks for participants who stopped treatment before disease progression and before completing 6 months of treatment and every 12 weeks for participants who stopped treatment before disease progression and

Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause.
From date of randomization up to 5 years. Every 8 weeks for participants who stopped treatment before disease progression and before completing 6 months of treatment and every 12 weeks for participants who stopped treatment before disease progression and

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Evaluate the efficacy of BMS-986489 vs durvalumab by Progression Free Survival (PFS).
Временное ограничение: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

Progression Free Survival (PFS) is defined as the time from start of study treatment to the date of an event, defined as the first documented radiological progression or death due to any cause.
Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab Objective Response Rate (ORR).
Временное ограничение: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

Objective Response Rate (ORR) is defined as the proportion of participants with BOR of CR or PR according to RECIST v1.1.
Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Clinical Benefit Rate (CBR).
Временное ограничение: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

Clinical Benefit Rate (CBR) is defined as the proportion of participants with BOR of CR or PR, or participants with SD lasting at least 180 days (i.e., ≥6 months) according to RECIST v1.1.
Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Disease Control Rate (DCR).
Временное ограничение: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

Disease Control Rate (DCR) is defined as the proportion of participants with BOR of CR, PR, or SD according to RECIST v1.1
Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Duration of Response (DoR).
Временное ограничение: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

Duration of Response (DoR) is defined as the duration from the first documented response (Complete Response (CR), Partial Response (PR), or Stable Disease (SD), according to RECIST v1.1) to the date of first documented disease progression or death.
Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Time to Progression (TtP).
Временное ограничение: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

Time to Progression (TtP) is defined as the time from the date of randomization to the date of first documented disease progression, according to RECIST v1.1.
Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by time to development of central nervous system (CNS) metastasis.
Временное ограничение: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

Time to development of central nervous system (CNS) metastasis is defined as the time from the date of randomization to the date of first documented CNS metastasis.
Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the number of participants with adverse events following administration of BMS-986489.
Временное ограничение: From Cycle 1 Day 1 to 100 days after the last dose of BMS-986489. Each cycle is 28 days.

Adverse Events to be evaluated per CTCAE v5.0 criteria from first dose of BMS-986489 to 100 days after the last dose of BMS-986489.
From Cycle 1 Day 1 to 100 days after the last dose of BMS-986489. Each cycle is 28 days.

Соавторы и исследователи

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

Спонсор

SCRI Development Innovations, LLC

Соавторы

Bristol-Myers Squibb

Следователи

  • Учебный стул: Melissa Johnson, MD, SCRI Development Innovations, LLC

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)

11 марта 2025 г.

Первичное завершение (Оцененный)

1 мая 2032 г.

Завершение исследования (Оцененный)

1 сентября 2032 г.

Даты регистрации исследования

Первый отправленный

8 января 2025 г.

Впервые представлено, что соответствует критериям контроля качества

8 января 2025 г.

Первый опубликованный (Действительный)

14 января 2025 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

21 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

16 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • LUN 567

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

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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