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Une étude portant sur l'efficacité et l'innocuité de LBL-007 plus tislelizumab en association avec le bévacizumab plus capécitabine par rapport au bévacizumab plus capécitabine chez des participants atteints d'un cancer colorectal non résécable ou métastatique

21 juillet 2026 mis à jour par: BeiGene

Une étude ouverte randomisée de phase 1b/2 portant sur l'efficacité et l'innocuité du LBL-007 plus tislelizumab en association avec le bévacizumab plus capécitabine par rapport au bévacizumab plus capécitabine comme traitement d'entretien chez les patients atteints d'un cancer colorectal compétent en matière de réparation microsatellite non résécable ou métastatique

Il s'agit d'une étude de phase 1b/2 visant à étudier l'efficacité et l'innocuité de LBL-007 plus Tislelizumab lorsqu'il est administré en association avec du bevacizumab plus capécitabine à des participants atteints d'un cancer colorectal.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

113

Phase

  • Phase 2
  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

14 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  • Le participant doit avoir une maladie mesurable telle que définie par RECIST version 1.1
  • A un adénocarcinome colorectal histologiquement confirmé avec une maladie métastatique ou non résécable (stade IV tel que défini par l'American Joint Committee on Cancer [AJCC] 8e édition)
  • Aucun traitement systémique antérieur pour le cancer colorectal (CCR) dans le cadre métastatique, à l'exception du traitement d'induction du traitement de première intention. Remarque : Le traitement local régional effectué pendant le traitement systémique d'induction est autorisé
  • Participants ayant terminé le traitement d'induction de première ligne, avec une réponse globale de maladie stable ou mieux

Critère d'exclusion:

  • Les participants dont la maladie est devenue résécable à la discrétion de l'investigateur pendant ou après le traitement d'induction ne sont pas éligibles
  • Traitement d'induction initié moins de 6 mois après la fin de toute chimiothérapie ou radiothérapie néoadjuvante ou adjuvante antérieure
  • Participants qui ont été traités avec un anticorps anti-récepteur du facteur de croissance épidermique (EGFR) dans le traitement d'induction
  • Toute thérapie antérieure ciblant la stimulation des lymphocytes T ou les voies de contrôle
  • Participants présentant des mutations documentées du proto-oncogène B-raf, de la sérine/thréonine kinase (BRAF) par des évaluations locales
  • Avoir localement ou centralement confirmé l'instabilité élevée des microsatellites (MSI-H) par la méthode de réaction en chaîne par polymérase (PCR) ou l'immunohistochimie (IHC) de réparation des mésappariements déficients (dMMR). Le résultat local est recommandé et acceptable pour l'inscription. Les participants sans résultats de tests locaux doivent subir une évaluation en laboratoire central. Remarque : les patients atteints de CCR avec des tumeurs sans déficit de réparation des mésappariements (MMR) ou un statut MSI-H sont classés comme pMMR ou microsatellite stable (MSS)

Remarque : D'autres critères définis par le protocole peuvent s'appliquer.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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
Autres noms:
  • LBL-007
Médicament: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Autres noms:
  • BGB-A317
Médicament: 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.
Médicament: 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.
Expérimental: 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).
Médicament: 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
Autres noms:
  • LBL-007
Médicament: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Autres noms:
  • BGB-A317
Médicament: 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.
Médicament: 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.
Expérimental: 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).
Médicament: 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
Autres noms:
  • LBL-007
Médicament: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Autres noms:
  • BGB-A317
Médicament: 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.
Médicament: 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.
Expérimental: 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).
Médicament: 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
Autres noms:
  • LBL-007
Médicament: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Autres noms:
  • BGB-A317
Médicament: 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.
Médicament: 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.
Expérimental: 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).
Médicament: 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
Autres noms:
  • LBL-007
Médicament: 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.
Médicament: 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.
Comparateur actif: 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).
Médicament: 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.
Médicament: 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.
Expérimental: 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).
Médicament: 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
Autres noms:
  • LBL-007
Médicament: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Autres noms:
  • BGB-A317
Médicament: 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.
Médicament: 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.
Comparateur actif: 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).
Médicament: 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.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

BeiGene

Les enquêteurs

  • Directeur d'études: Study Director, BeiGene

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 janvier 2023

Achèvement primaire (Réel)

23 mai 2025

Achèvement de l'étude (Estimé)

31 décembre 2026

Dates d'inscription aux études

Première soumission

20 octobre 2022

Première soumission répondant aux critères de contrôle qualité

1 novembre 2022

Première publication (Réel)

8 novembre 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BGB-A317-LBL-007-201
  • CTR20223077 (Identificateur de registre: ChinaDrugTrials)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Beigene partage les données sur les études terminées de manière responsable et fournit des chercheurs scientifiques et médicaux qualifiés à l'accès aux données et à la documentation de soutien aux essais cliniques dans les dossiers pour les médicaments et les indications après la soumission et l'approbation aux États-Unis, en Chine et en Europe. Les essais cliniques soutenant les approbations locales ultérieurs, les nouvelles indications ou les produits combinés sont éligibles pour le partage une fois les approbations réglementaires correspondantes.

Beigene ne partage les données que lorsqu'elles sont autorisées par les lois et réglementations applicables sur la confidentialité et la sécurité des données, lorsqu'elle est possible de le faire sans compromettre la confidentialité des participants à l'étude et d'autres considérations.

Des chercheurs qualifiés ayant des compétences appropriés qui sont engagés dans de nouvelles recherches scientifiques peuvent soumettre une demande de données au niveau des participants avec une proposition de recherche pour Review Beigene. Les équipes de recherche doivent inclure un biostatisticien et signer un accord de partage de données avant d'avoir accès aux données des essais cliniques.

Délai de partage IPD

Voir Description du plan

Critères d'accès au partage IPD

Voir Description du plan

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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