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BMS-986489 (Atigotatug + Nivolumab) frente a Durvalumab en cáncer de pulmón de células pequeñas en estadio limitado (TIGOS-LS) (TIGOS-LS)

16 de septiembre de 2026 actualizado por: SCRI Development Innovations, LLC

Un estudio aleatorizado y abierto de BMS-986489 (combinación de dosis fija de Atigotatug + Nivolumab) frente a Durvalumab como terapia de consolidación después de quimiorradioterapia en el cáncer de pulmón de células pequeñas en estadio limitado (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

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

250

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: 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.
Comparador activo: 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.
Droga: Durvalumab

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS).
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluate the efficacy of BMS-986489 vs durvalumab by Progression Free Survival (PFS).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

SCRI Development Innovations, LLC

Colaboradores

Bristol-Myers Squibb

Investigadores

  • Silla de estudio: Melissa Johnson, MD, SCRI Development Innovations, LLC

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de marzo de 2025

Finalización primaria (Estimado)

1 de mayo de 2032

Finalización del estudio (Estimado)

1 de septiembre de 2032

Fechas de registro del estudio

Enviado por primera vez

8 de enero de 2025

Primero enviado que cumplió con los criterios de control de calidad

8 de enero de 2025

Publicado por primera vez (Actual)

14 de enero de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • LUN 567

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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