Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Um estudo investigando a eficácia e a segurança de LBL-007 Plus Tislelizumab em combinação com Bevacizumab Plus Capecitabine versus Bevacizumab Plus Capecitabine em participantes com câncer colorretal irressecável ou metastático

21 de julho de 2026 atualizado por: BeiGene

Um estudo de fase 1b/2, randomizado, aberto, investigando a eficácia e a segurança de LBL-007 mais Tislelizumabe em combinação com Bevacizumabe mais capecitabina versus bevacizumabe mais capecitabina como terapia de manutenção em pacientes com câncer colorretal estável ou metastático com microssatélites irressecáveis ​​ou com reparo incompatível

Este é um estudo de Fase 1b/2 para investigar a eficácia e segurança de LBL-007 mais Tislelizumabe quando administrado em combinação com bevacizumabe mais capecitabina a participantes com câncer colorretal.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

113

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Austrália
    • New South Wales
      • Blacktown, New South Wales, Austrália, NSW 2148
        • Blacktown Cancer and Haematology Centre
      • Orange, New South Wales, Austrália, NSW 2800
        • Orange Health Service (Central West Cancer Care Centre)
      • Wagga Wagga, New South Wales, Austrália, NSW 2650
        • Riverina Cancer Care Centre
      • Waratah, New South Wales, Austrália, NSW 2298
        • Calvary Mater Newcastle
    • Queensland
      • Benowa, Queensland, Austrália, QLD 4217
        • Pindara Private Hospital
    • Victoria
      • Clayton, Victoria, Austrália, VIC 3168
        • Monash Health
      • Melbourne, Victoria, Austrália, VIC 3004
        • The Alfred Hospital
    • Western Australia
      • Murdoch, Western Australia, Austrália, WA 6150
        • St John of God, Murdoch
      • Nedlands, Western Australia, Austrália, WA 6009
        • One Clinical Research
  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Hospital of Anhui Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, China, 102218
        • Beijing Tsinghua Changgung Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Quanzhou, Fujian, China, 362000
        • Quanzhou First Affliated Hospital of Fujian Medical University
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • ZhuJiang Hospital of Southern Medical University
      • Shantou, Guangdong, China, 515041
        • the First Affiliated Hospital of Shantou University Medical College
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Jiangsu
      • Nantong, Jiangsu, China, 215124
        • Nantong First Peoples Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
      • Jining, Shandong, China, 272000
        • Jining No1 Peoples Hospital West Branch
      • Linyi, Shandong, China, 276000
        • Linyi Peoples Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200123
        • Shanghai East Hospital Branch Hospital
      • Shanghai, Shanghai Municipality, China, 200000
        • Renji Hospital Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincial Cancer Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin Municipality, China, 300121
        • Tianjin Union Medical Center (Nankai University Affiliated Hospital)
    • Xinjiang
      • Karamay, Xinjiang, China, 834009
        • Karamay Central Hospital of Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • The Xinjiang Uygur Autonomous Region Peoples Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • 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
  • Porto Rico
      • Rio Piedras, Porto Rico, 00935
        • Pan American Oncology Trials, LLC

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

14 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • O participante deve ter doença mensurável, conforme definido pelo RECIST versão 1.1
  • Tem um adenocarcinoma colorretal confirmado histologicamente com doença metastática ou irressecável (Estágio IV conforme definido pelo American Joint Committee on Cancer [AJCC] 8ª edição)
  • Nenhuma terapia sistêmica anterior para câncer colorretal (CRC) no cenário metastático, exceto para o tratamento de indução da terapia de primeira linha. Nota: O tratamento regional local realizado durante o tratamento sistêmico de indução é permitido
  • Participantes que completaram o tratamento de indução de primeira linha, com uma resposta geral de doença estável ou melhor

Critério de exclusão:

  • Os participantes cuja doença se tornou ressecável a critério do investigador durante ou após o tratamento de indução não são elegíveis
  • Tratamento de indução iniciado menos de 6 meses após a conclusão de qualquer quimioterapia ou radioterapia neoadjuvante ou adjuvante anterior
  • Participantes que foram tratados com anticorpo antirreceptor do fator de crescimento epidérmico (EGFR) no tratamento de indução
  • Qualquer terapia anterior direcionada à estimulação de células T ou vias de checkpoint
  • Participantes com mutações documentadas do proto-oncogene B-raf, serina/treonina quinase (BRAF) por avaliações locais
  • Ter alta instabilidade de microssatélite confirmada local ou centralmente (MSI-H) pelo método de reação em cadeia da polimerase (PCR) ou imuno-histoquímica (IHC) de reparo de incompatibilidade deficiente (dMMR). O resultado local é recomendado e aceitável para inscrição. Os participantes sem resultados de testes locais são obrigados a fazer uma avaliação laboratorial central. Nota: Pacientes com CRC com tumores sem deficiência de reparo incompatível (MMR) ou status MSI-H são categorizados como pMMR ou microssatélite estável (MSS)

Observação: outros critérios definidos pelo protocolo podem ser aplicados.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: 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
Outros nomes:
  • LBL-007
Medicamento: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Outros nomes:
  • BGB-A317
Medicamento: 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.
Medicamento: 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).
Medicamento: 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
Outros nomes:
  • LBL-007
Medicamento: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Outros nomes:
  • BGB-A317
Medicamento: 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.
Medicamento: 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).
Medicamento: 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
Outros nomes:
  • LBL-007
Medicamento: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Outros nomes:
  • BGB-A317
Medicamento: 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.
Medicamento: 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).
Medicamento: 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
Outros nomes:
  • LBL-007
Medicamento: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Outros nomes:
  • BGB-A317
Medicamento: 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.
Medicamento: 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).
Medicamento: 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
Outros nomes:
  • LBL-007
Medicamento: 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.
Medicamento: 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 Ativo: 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).
Medicamento: 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.
Medicamento: 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).
Medicamento: 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
Outros nomes:
  • LBL-007
Medicamento: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Outros nomes:
  • BGB-A317
Medicamento: 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.
Medicamento: 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 Ativo: 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).
Medicamento: 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.
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

BeiGene

Investigadores

  • Diretor de estudo: Study Director, BeiGene

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de janeiro de 2023

Conclusão Primária (Real)

23 de maio de 2025

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

20 de outubro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de novembro de 2022

Primeira postagem (Real)

8 de novembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

A Beigene compartilha dados sobre estudos concluídos com responsabilidade e fornece pesquisadores científicos e médicos qualificados acesso a dados e documentação de apoio a ensaios clínicos em dossiers para medicamentos e indicações após a submissão e aprovação nos Estados Unidos, China e Europa. Os ensaios clínicos que apóiam as aprovações locais subsequentes, novas indicações ou produtos combinados são elegíveis para compartilhar uma vez que as aprovações regulatórias correspondentes são alcançadas.

A begene compartilha dados somente quando permitido pelas leis e regulamentos de privacidade e segurança de dados aplicáveis, quando é viável fazê -lo sem comprometer a privacidade dos participantes do estudo e outras considerações.

Pesquisadores qualificados com competências apropriadas envolvidas em novas pesquisas científicas podem enviar uma solicitação de dados no nível dos participantes com uma proposta de pesquisa para revisão de begene. As equipes de pesquisa devem incluir um bioestatístico e assinar um contrato de compartilhamento de dados antes de receber acesso a dados de ensaios clínicos.

Prazo de Compartilhamento de IPD

Veja a descrição do plano

Critérios de acesso de compartilhamento IPD

Veja a descrição do plano

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever