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Uno studio che indaga l'efficacia e la sicurezza di LBL-007 Plus Tislelizumab in combinazione con Bevacizumab Plus Capecitabina rispetto a Bevacizumab Plus Capecitabina in partecipanti con carcinoma del colon-retto non resecabile o metastatico

21 luglio 2026 aggiornato da: BeiGene

Uno studio di fase 1b/2, randomizzato, in aperto che indaga l'efficacia e la sicurezza di LBL-007 Plus Tislelizumab in combinazione con Bevacizumab Plus Capecitabina rispetto a Bevacizumab Plus Capecitabina come terapia di mantenimento in pazienti con carcinoma colorettale non resecabile o metastatico stabile/mancata corrispondenza dei microsatelliti

Questo è uno studio di fase 1b/2 per valutare l'efficacia e la sicurezza di LBL-007 più Tislelizumab quando somministrato in combinazione con bevacizumab più capecitabina a partecipanti con cancro del colon-retto.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

113

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

14 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Il partecipante deve avere una malattia misurabile come definito da RECIST versione 1.1
  • Ha un adenocarcinoma colorettale istologicamente confermato con malattia metastatica o non resecabile (stadio IV come definito dall'American Joint Committee on Cancer [AJCC] 8a edizione)
  • Nessuna precedente terapia sistemica per il cancro del colon-retto (CRC) nel contesto metastatico ad eccezione del trattamento di induzione della terapia di prima linea. Nota: è consentito il trattamento locale regionale eseguito durante il trattamento sistemico di induzione
  • - Partecipanti che hanno completato il trattamento di induzione di prima linea, con una risposta complessiva di malattia stabile o migliore

Criteri di esclusione:

  • I partecipanti la cui malattia è diventata resecabile a discrezione dello sperimentatore durante o dopo il trattamento di induzione non sono ammissibili
  • Trattamento di induzione iniziato meno di 6 mesi dal completamento di qualsiasi precedente chemioterapia o radioterapia neoadiuvante o adiuvante
  • - Partecipanti che sono stati trattati con anticorpi anti-recettore del fattore di crescita epidermico (EGFR) nel trattamento di induzione
  • Qualsiasi terapia precedente mirata alla stimolazione delle cellule T o ai percorsi del checkpoint
  • Partecipanti con mutazioni documentate del proto-oncogene B-raf, serina/treonina chinasi (BRAF) mediante valutazioni locali
  • Avere un'instabilità dei microsatelliti confermata localmente o centralmente (MSI-H) mediante il metodo della reazione a catena della polimerasi (PCR) o l'immunoistochimica (IHC) di riparazione del disadattamento carente (dMMR). Il risultato locale è raccomandato e accettabile per l'arruolamento. I partecipanti senza risultati di test locali devono sottoporsi a una valutazione di laboratorio centrale. Nota: i pazienti con CRC con tumori senza deficit di mismatch repair (MMR) o stato MSI-H sono classificati come pMMR o microsatellite stable (MSS)

Nota: potrebbero essere applicati altri criteri definiti dal protocollo.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Altri nomi:
  • LBL-007
Droga: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Altri nomi:
  • 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.
Sperimentale: 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
Altri nomi:
  • LBL-007
Droga: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Altri nomi:
  • 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.
Sperimentale: 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
Altri nomi:
  • LBL-007
Droga: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Altri nomi:
  • 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.
Sperimentale: 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
Altri nomi:
  • LBL-007
Droga: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Altri nomi:
  • 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.
Sperimentale: 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
Altri nomi:
  • 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.
Comparatore attivo: 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.
Sperimentale: 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
Altri nomi:
  • LBL-007
Droga: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Altri nomi:
  • 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

BeiGene

Investigatori

  • Direttore dello studio: Study Director, BeiGene

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 gennaio 2023

Completamento primario (Effettivo)

23 maggio 2025

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

20 ottobre 2022

Primo inviato che soddisfa i criteri di controllo qualità

1 novembre 2022

Primo Inserito (Effettivo)

8 novembre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BGB-A317-LBL-007-201
  • CTR20223077 (Identificatore di registro: ChinaDrugTrials)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Beigene condivide i dati sugli studi completati in modo responsabile e fornisce ai ricercatori scientifici e medici qualificati l'accesso ai dati e la documentazione di supporto per gli studi clinici in dossiers per medicinali e indicazioni dopo l'invio e l'approvazione negli Stati Uniti, in Cina e in Europa. Studi clinici a supporto delle successive approvazioni locali, nuove indicazioni o prodotti combinati sono idonei per la condivisione una volta raggiunte le corrispondenti approvazioni normative.

Beigene condivide i dati solo quando consentito dalle leggi e nei regolamenti applicabili sulla privacy e sulla sicurezza dei dati, quando è possibile farlo senza compromettere la privacy dei partecipanti allo studio e altre considerazioni.

I ricercatori qualificati con competenze adeguate che sono impegnate in nuove ricerche scientifiche possono presentare una richiesta di dati a livello di partecipante con una proposta di ricerca per Beigene Review. I team di ricerca devono includere un biostatistico e firmare un accordo di condivisione dei dati prima di ricevere l'accesso ai dati di sperimentazione clinica.

Periodo di condivisione IPD

Vedi Descrizione del piano

Criteri di accesso alla condivisione IPD

Vedi Descrizione del piano

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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