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Un estudio que investiga la eficacia y la seguridad de LBL-007 más tislelizumab en combinación con bevacizumab más capecitabina versus bevacizumab más capecitabina en participantes con cáncer colorrectal irresecable o metastásico

21 de julio de 2026 actualizado por: BeiGene

Un estudio de fase 1b/2, aleatorizado, abierto, que investiga la eficacia y la seguridad de LBL-007 más tislelizumab en combinación con bevacizumab más capecitabina versus bevacizumab más capecitabina como terapia de mantenimiento en pacientes con cáncer colorrectal estable o no compatible con microsatélites metastásicos o irresecable

Este es un estudio de fase 1b/2 para investigar la eficacia y seguridad de LBL-007 más tislelizumab cuando se administra en combinación con bevacizumab más capecitabina a participantes con cáncer colorrectal.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

113

Fase

  • Fase 2
  • Fase 1

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

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, NSW 2148
        • Blacktown Cancer and Haematology Centre
      • Orange, New South Wales, Australia, NSW 2800
        • Orange Health Service (Central West Cancer Care Centre)
      • Wagga Wagga, New South Wales, Australia, NSW 2650
        • Riverina Cancer Care Centre
      • Waratah, New South Wales, Australia, NSW 2298
        • Calvary Mater Newcastle
    • Queensland
      • Benowa, Queensland, Australia, QLD 4217
        • Pindara Private Hospital
    • Victoria
      • Clayton, Victoria, Australia, VIC 3168
        • Monash Health
      • Melbourne, Victoria, Australia, VIC 3004
        • The Alfred Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, WA 6150
        • St John of God, Murdoch
      • Nedlands, Western Australia, Australia, WA 6009
        • One Clinical Research
  • Estados Unidos
    • Alaska
      • Anchorage, Alaska, Estados Unidos, 99508-2974
        • Alaska Oncology and Hematology, LLC
    • Arizona
      • Gilbert, Arizona, Estados Unidos, 85234-2165
        • Banner MD Anderson Cancer Center
    • California
      • Cerritos, California, Estados Unidos, 90703
        • Helios Clinical Research
      • Los Angeles, California, Estados Unidos, 90067-2011
        • Valkyrie Clinical Trials
      • Los Angeles, California, Estados Unidos, 90089-1019
        • Usc Norris Comprehensive Cancer Center (Nccc)
      • Los Angeles, California, Estados Unidos, 90095-3075
        • UCLA Hematologyoncology
      • Newport Beach, California, Estados Unidos, 92663-4162
        • Hoag Memorial Presbyterian
      • Vallejo, California, Estados Unidos, 94589-2441
        • Kaiser Permanente Northern California
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32207-8432
        • Baptist MD Anderson Cancer Center
    • Indiana
      • Fort Wayne, Indiana, Estados Unidos, 46804
        • Fort Wayne Medical Oncology and Hematology
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40536-7001
        • University of Kentucky Markey Cancer Center
      • Lexington, Kentucky, Estados Unidos, 40503-1466
        • Baptist Health Lexington
      • Louisville, Kentucky, Estados Unidos, 40217-1395
        • Norton Cancer Institute
    • Louisiana
      • Covington, Louisiana, Estados Unidos, 70433-7512
        • Pontchartrain Cancer Center
      • New Orleans, Louisiana, Estados Unidos, 70121-2429
        • Ochsner Clinic Foundation
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110-1010
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, Estados Unidos, 59102-6746
        • St Vincent Frontier Cancer Center
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89169-3321
        • Comprehensive Cancer Centers of Nevada
      • Reno, Nevada, Estados Unidos, 89511-2250
        • Cancer Care Specialists
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87102-4517
        • University of New Mexico Comprehensive Cancer Center
    • New York
      • Mineola, New York, Estados Unidos, 11501-3957
        • Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital
      • New York, New York, Estados Unidos, 10032
        • Columbia University Medical Center
      • New York, New York, Estados Unidos, 10016-2708
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710-2000
        • Duke Cancer Center
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37920-1511
        • University of Tennessee Medical Center
    • Texas
      • Dallas, Texas, Estados Unidos, 75390-7208
        • UT Southwestern Medical Center
      • San Antonio, Texas, Estados Unidos, 78229-4427
        • UT Health San Antonio Mays Cancer Center
    • Virginia
      • Fairfax, Virginia, Estados Unidos, 22031-2171
        • Virginia Cancer Specialists
    • Washington
      • Spokane Valley, Washington, Estados Unidos, 99216-1020
        • Cancer Care Northwest
      • Tacoma, Washington, Estados Unidos, 98405
        • MultiCare Health System Institute for Research and Innovation
  • Porcelana
    • Anhui
      • Hefei, Anhui, Porcelana, 230601
        • The Second Hospital of Anhui Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, Porcelana, 102218
        • Beijing Tsinghua Changgung Hospital
    • Fujian
      • Fuzhou, Fujian, Porcelana, 350001
        • Fujian Medical University Union Hospital
      • Quanzhou, Fujian, Porcelana, 362000
        • Quanzhou First Affliated Hospital of Fujian Medical University
      • Xiamen, Fujian, Porcelana, 361003
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510000
        • ZhuJiang Hospital of Southern Medical University
      • Shantou, Guangdong, Porcelana, 515041
        • the First Affiliated Hospital of Shantou University Medical College
    • Henan
      • Zhengzhou, Henan, Porcelana, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, Porcelana, 430079
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, Porcelana, 410013
        • Hunan Cancer Hospital
    • Jiangsu
      • Nantong, Jiangsu, Porcelana, 215124
        • Nantong First Peoples Hospital
    • Jilin
      • Changchun, Jilin, Porcelana, 130021
        • The First Hospital of Jilin University
    • Shandong
      • Jinan, Shandong, Porcelana, 250117
        • Shandong Cancer Hospital
      • Jining, Shandong, Porcelana, 272000
        • Jining No1 Peoples Hospital West Branch
      • Linyi, Shandong, Porcelana, 276000
        • Linyi Peoples Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200123
        • Shanghai East Hospital Branch Hospital
      • Shanghai, Shanghai Municipality, Porcelana, 200000
        • Renji Hospital Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, Porcelana, 030013
        • Shanxi Provincial Cancer Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Porcelana, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin Municipality, Porcelana, 300121
        • Tianjin Union Medical Center (Nankai University Affiliated Hospital)
    • Xinjiang
      • Karamay, Xinjiang, Porcelana, 834009
        • Karamay Central Hospital of Xinjiang
      • Ürümqi, Xinjiang, Porcelana, 830001
        • The Xinjiang Uygur Autonomous Region Peoples Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310009
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Pan American Oncology Trials, LLC

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

14 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • El participante debe tener una enfermedad medible según lo definido por RECIST versión 1.1
  • Tiene un adenocarcinoma colorrectal histológicamente confirmado con enfermedad metastásica o no resecable (Estadio IV según lo define el Comité Conjunto Estadounidense sobre el Cáncer [AJCC] 8.ª edición)
  • Sin tratamiento sistémico previo para el cáncer colorrectal (CCR) en el entorno metastásico excepto para el tratamiento de inducción del tratamiento de primera línea. Nota: Se permite el tratamiento regional local realizado durante el tratamiento sistémico de inducción.
  • Participantes que hayan completado el tratamiento de inducción de primera línea, con una respuesta general de enfermedad estable o mejor

Criterio de exclusión:

  • Los participantes cuya enfermedad se haya vuelto resecable a discreción del investigador durante o después del tratamiento de inducción no son elegibles
  • Tratamiento de inducción iniciado menos de 6 meses después de la finalización de cualquier quimioterapia o radioterapia neoadyuvante o adyuvante previa
  • Participantes que han sido tratados con anticuerpos contra el receptor del factor de crecimiento epidérmico (EGFR) en el tratamiento de inducción
  • Cualquier terapia previa dirigida a la estimulación de células T o vías de puntos de control
  • Participantes con mutaciones documentadas del protooncogén B-raf, serina/treonina quinasa (BRAF) mediante evaluaciones locales
  • Tener alta inestabilidad de microsatélites (MSI-H) confirmada local o centralmente mediante el método de reacción en cadena de la polimerasa (PCR) o inmunohistoquímica (IHC) de reparación de desajustes deficientes (dMMR). Se recomienda un resultado local y es aceptable para la inscripción. Los participantes sin resultados de pruebas locales deben tener una evaluación de laboratorio central. Nota: Los pacientes con CRC con tumores sin deficiencia de reparación de errores de emparejamiento (MMR) o estado MSI-H se clasifican como pMMR o microsatélites estables (MSS)

Nota: Es posible que se apliquen otros criterios definidos por el protocolo.

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: Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
Droga: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Otros nombres:
  • LBL-007
Droga: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Otros nombres:
  • BGB-A317
Droga: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Droga: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Experimental: Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Droga: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Otros nombres:
  • LBL-007
Droga: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Otros nombres:
  • BGB-A317
Droga: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Droga: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Experimental: Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine

Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.

The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Droga: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Otros nombres:
  • LBL-007
Droga: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Otros nombres:
  • BGB-A317
Droga: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Droga: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Experimental: Phase 2: Arm A:PD-L1-positive: Alcestobart High Dose +Tislelizumab + Bevacizumab +Fluoropyrimidine
PD-L1 (programmed cell death protein ligand-1)-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Droga: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Otros nombres:
  • LBL-007
Droga: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Otros nombres:
  • BGB-A317
Droga: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Droga: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Experimental: Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine
PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Droga: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Otros nombres:
  • LBL-007
Droga: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Droga: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Comparador activo: Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine

PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.

The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Droga: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Droga: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Experimental: Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Droga: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Otros nombres:
  • LBL-007
Droga: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Otros nombres:
  • BGB-A317
Droga: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Droga: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Comparador activo: Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine

PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.

The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Droga: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Droga: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Periodo de tiempo: From first dose of study drug up to 30 days after last dose; maximum time on treatment was 16.2 months.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose-

  • resulted in death,
  • was life threatening,
  • required hospitalization or prolongation of existing hospitalization,
  • resulted in disability/incapacity,
  • was a congenital anomaly/birth defect.
From first dose of study drug up to 30 days after last dose; maximum time on treatment was 16.2 months.
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Periodo de tiempo: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)
PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occured first.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Periodo de tiempo: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)

ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1.

  • CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.
  • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)
Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Periodo de tiempo: From first documented response until disease progression or death (maximum follow-up time for DOR was 4.2 months)
DOR is defined as the time from the first determination of an objective confirmed response after randomization until the first documentation of disease progression or death, whichever comes first.
From first documented response until disease progression or death (maximum follow-up time for DOR was 4.2 months)
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Negative Arms D and E
Periodo de tiempo: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months)
PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months)
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Negative Arms D and E
Periodo de tiempo: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months))

ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1.

  • CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.
  • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months))
Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Negative Arms D and E
Periodo de tiempo: From first documented response until disease progression or death (maximum follow-up time for DOR was 2.8 months)
DOR, defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first.
From first documented response until disease progression or death (maximum follow-up time for DOR was 2.8 months)
Phase 2: Number of Participants With Treatment-emergent AEs and SAEs
Periodo de tiempo: From first dose of study drug up to 30 days after last dose; maximum time on treatment in Phase 2 was 10.9 months

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose-

  • resulted in death,
  • was life threatening,
  • required hospitalization or prolongation of existing hospitalization,
  • resulted in disability/incapacity,
  • was a congenital anomaly/birth defect.
From first dose of study drug up to 30 days after last dose; maximum time on treatment in Phase 2 was 10.9 months

Colaboradores e Investigadores

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

Patrocinador

BeiGene

Investigadores

  • Director de estudio: Study Director, BeiGene

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)

29 de enero de 2023

Finalización primaria (Actual)

23 de mayo de 2025

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

20 de octubre de 2022

Primero enviado que cumplió con los criterios de control de calidad

1 de noviembre de 2022

Publicado por primera vez (Actual)

8 de noviembre de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de julio de 2026

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

21 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BGB-A317-LBL-007-201
  • CTR20223077 (Identificador de registro: ChinaDrugTrials)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Beigene comparte datos sobre estudios completados de manera responsable y proporciona a los investigadores científicos y médicos calificados acceso a datos y documentación de apoyo para ensayos clínicos en expedientes para medicamentos e indicaciones después de la presentación y aprobación en los Estados Unidos, China y Europa. Los ensayos clínicos que respaldan las aprobaciones locales posteriores, nuevas indicaciones o productos combinados son elegibles para compartir una vez que se logran las aprobaciones regulatorias correspondientes.

Beigene comparte datos solo cuando se permite las leyes y regulaciones de privacidad y seguridad de datos aplicables, cuando es factible hacerlo sin comprometer la privacidad de los participantes del estudio y otras consideraciones.

Los investigadores calificados con competencias apropiadas que participan en una nueva investigación científica pueden presentar una solicitud de datos a nivel de participante con una propuesta de investigación para la revisión del beigene. Los equipos de investigación deben incluir un bioestadístico y firmar un acuerdo de intercambio de datos antes de recibir acceso a datos de ensayos clínicos.

Marco de tiempo para compartir IPD

Ver Descripción del plan

Criterios de acceso compartido de IPD

Ver Descripción del plan

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

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

producto fabricado y exportado desde los 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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