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En undersøgelse, der undersøger effektiviteten og sikkerheden af ​​LBL-007 Plus Tislelizumab i kombination med Bevacizumab Plus Capecitabine versus Bevacizumab Plus Capecitabine hos deltagere med inoperabel eller metastatisk kolorektal cancer

21. juli 2026 opdateret af: BeiGene

En fase 1b/2, randomiseret, åben-label undersøgelse, der undersøger effektiviteten og sikkerheden af ​​LBL-007 Plus Tislelizumab i kombination med Bevacizumab Plus Capecitabine versus Bevacizumab Plus Capecitabine som vedligeholdelsesterapi hos patienter med uoperabel eller metastatisk mikrosatellitreparation, stabil/mismatchende farvestabilitet

Dette er et fase 1b/2-studie for at undersøge effektiviteten og sikkerheden af ​​LBL-007 plus Tislelizumab, når det administreres i kombination med bevacizumab plus capecitabin til deltagere med kolorektal cancer.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

113

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Deltageren skal have målbar sygdom som defineret i RECIST version 1.1
  • Har et histologisk bekræftet kolorektalt adenokarcinom med metastatisk eller ikke-operabel sygdom (stadium IV som defineret af American Joint Committee on Cancer [AJCC] 8. udgave)
  • Ingen forudgående systemisk behandling for kolorektal cancer (CRC) i metastaserende omgivelser bortset fra induktionsbehandling af førstelinjebehandling. Bemærk: Lokal regional behandling udført under induktionssystemisk behandling er tilladt
  • Deltagere, der har gennemført første-linje-induktionsbehandlingen, med en samlet respons på stabil sygdom eller bedre

Ekskluderingskriterier:

  • Deltagere, hvis sygdom er blevet resecerbar efter investigatorens skøn under eller efter induktionsbehandling, er ikke kvalificerede
  • Induktionsbehandling påbegyndt mindre end 6 måneder efter afslutning af tidligere neoadjuverende eller adjuverende kemoterapi eller strålebehandling
  • Deltagere, der er blevet behandlet med anti-epidermal vækstfaktor receptor (EGFR) antistof i induktionsbehandlingen
  • Enhver tidligere terapi rettet mod T-cellestimulering eller checkpoint-veje
  • Deltagere med dokumenterede B-raf proto-onkogen, serin/threoninkinase (BRAF) mutationer ved lokale vurderinger
  • Har lokalt eller centralt bekræftet mikrosatellit-instabilitet-høj (MSI-H) ved polymerasekædereaktion (PCR) metode eller mangelfuld mismatch reparation (dMMR) immunhistokemi (IHC). Lokalt resultat anbefales og accepteres for tilmelding. Deltagere uden lokale testresultater skal have en central laboratorievurdering. Bemærk: CRC-patienter med tumorer uden mismatch repair (MMR) mangel eller MSI-H status kategoriseres som pMMR eller microsatellite stabil (MSS)

Bemærk: Andre protokoldefinerede kriterier kan være gældende.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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
Andre navne:
  • LBL-007
Medicin: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andre navne:
  • BGB-A317
Medicin: 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.
Medicin: 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.
Eksperimentel: 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).
Medicin: 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
Andre navne:
  • LBL-007
Medicin: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andre navne:
  • BGB-A317
Medicin: 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.
Medicin: 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.
Eksperimentel: 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).
Medicin: 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
Andre navne:
  • LBL-007
Medicin: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andre navne:
  • BGB-A317
Medicin: 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.
Medicin: 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.
Eksperimentel: 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).
Medicin: 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
Andre navne:
  • LBL-007
Medicin: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andre navne:
  • BGB-A317
Medicin: 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.
Medicin: 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.
Eksperimentel: 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).
Medicin: 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
Andre navne:
  • LBL-007
Medicin: 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.
Medicin: 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.
Aktiv komparator: 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).
Medicin: 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.
Medicin: 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.
Eksperimentel: 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).
Medicin: 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
Andre navne:
  • LBL-007
Medicin: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andre navne:
  • BGB-A317
Medicin: 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.
Medicin: 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.
Aktiv komparator: 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).
Medicin: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

BeiGene

Efterforskere

  • Studieleder: Study Director, BeiGene

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. januar 2023

Primær færdiggørelse (Faktiske)

23. maj 2025

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

20. oktober 2022

Først indsendt, der opfyldte QC-kriterier

1. november 2022

Først opslået (Faktiske)

8. november 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BGB-A317-LBL-007-201
  • CTR20223077 (Registry Identifier: ChinaDrugTrials)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Beigene deler data om afsluttede undersøgelser på ansvar og giver kvalificerede videnskabelige og medicinske forskere adgang til data og understøttende dokumentation for kliniske forsøg i dossierer for medicin og indikationer efter indsendelse og godkendelse i USA, Kina og Europa. Kliniske forsøg, der understøtter efterfølgende lokale godkendelser, nye indikationer eller kombinationsprodukter, er berettigede til at dele, når der er opnået tilsvarende lovgivningsmæssige godkendelser.

Beigene deler kun data, når de er tilladt i henhold til gældende databeskyttelse og sikkerhedslovgivning og -regler, når det er muligt at gøre det uden at gå på kompromis med privatlivets fred for undersøgelsesdeltagere og andre overvejelser.

Kvalificerede forskere med passende kompetencer, der beskæftiger sig med ny videnskabelig forskning, kan indsende en anmodning om data på deltagerniveau med et forskningsforslag til Beigene Review. Forskningsteam skal omfatte en biostatistiker og underskrive en datadelingsaftale inden de modtager adgang til kliniske forsøgsdata.

IPD-delingstidsramme

Se planbeskrivelse

IPD-delingsadgangskriterier

Se planbeskrivelse

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner