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BMS-986489 (Atigotatug + Niwolumab) w porównaniu z Durwalumabem w leczeniu drobnokomórkowego raka płuc o ograniczonym stadium (TIGOS-LS) (TIGOS-LS)

16 września 2026 zaktualizowane przez: SCRI Development Innovations, LLC

Randomizowane, otwarte badanie oceniające BMS-986489 (skojarzenie atigatugu + niwolumabu w stałej dawce) w porównaniu z durwalumabem w leczeniu konsolidacyjnym po chemioradioterapii w leczeniu drobnokomórkowego raka płuc o ograniczonym stopniu zaawansowania (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

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

250

Faza

  • Faza 2

Kontakty i lokalizacje

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

Lokalizacje studiów

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

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:

  • 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

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: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: 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.
Aktywny komparator: 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.
Lek: Durvalumab

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS).
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Evaluate the efficacy of BMS-986489 vs durvalumab by Progression Free Survival (PFS).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

SCRI Development Innovations, LLC

Współpracownicy

Bristol-Myers Squibb

Śledczy

  • Krzesło do nauki: Melissa Johnson, MD, SCRI Development Innovations, LLC

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)

11 marca 2025

Zakończenie podstawowe (Szacowany)

1 maja 2032

Ukończenie studiów (Szacowany)

1 września 2032

Daty rejestracji na studia

Pierwszy przesłany

8 stycznia 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 stycznia 2025

Pierwszy wysłany (Rzeczywisty)

14 stycznia 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • LUN 567

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

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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