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Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT (DURGA-5)

10. august 2026 opdateret af: AstraZeneca

Phase III Open-Label, Randomised Study of Consolidation With AZD0120 (Dual-Targeting BCMA/CD19 CAR-T) vs Continuous Standard Therapy in NDMM Patients Ineligible for ASCT as Initial Therapy (DURGA-5)

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of standard induction regimens (IsaVRd and DRd) followed by AZD0120 versus standard induction regimens followed by continuous therapy (IsaRd and DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) as initial therapy.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary objective is to demonstrate the superiority of IsaVRd or DRd induction followed by a single administration of AZD0120 compared to IsaVRd or DRd induction followed by continuous IsaRd or DRd in terms of progression-free survival (PFS) according to IMWG 2016 criteria, and as assessed by Blinded Independent Central Review (BICR) and miminal residual disease (MRD) negative complete response (CR) rate at 9 months post-randomisation in participants with NDMM who are ineligible to receive ASCT as initial therapy.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

750

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Australien
      • Concord, Australien, 2139
        • Ikke rekrutterer endnu
        • Research Site
      • Darlinghurst, Australien, 2010
        • Ikke rekrutterer endnu
        • Research Site
      • East Melbourne, Australien, 3002
        • Ikke rekrutterer endnu
        • Research Site
      • Fitzroy, Australien, VIC3065
        • Rekruttering
        • Research Site
      • Liverpool, Australien, 2170
        • Ikke rekrutterer endnu
        • Research Site
      • Melbourne, Australien, 3004
        • Ikke rekrutterer endnu
        • Research Site
      • Murdoch, Australien, 6150
        • Ikke rekrutterer endnu
        • Research Site
      • Waratah, Australien, 2298
        • Ikke rekrutterer endnu
        • Research Site
  • Brasilien
      • Salvador, Brasilien, 41253-190
        • Ikke rekrutterer endnu
        • Research Site
      • São Paulo, Brasilien, 05651-901
        • Ikke rekrutterer endnu
        • Research Site
      • São Paulo, Brasilien, 01525-001
        • Ikke rekrutterer endnu
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Ikke rekrutterer endnu
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Ikke rekrutterer endnu
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Ikke rekrutterer endnu
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ikke rekrutterer endnu
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Ikke rekrutterer endnu
        • Research Site
      • Sherbrooke, Quebec, Canada, J1G 2K7
        • Ikke rekrutterer endnu
        • Research Site
  • Danmark
      • Århus N, Danmark, 8200
        • Ikke rekrutterer endnu
        • Research Site
  • Det Forenede Kongerige
      • Edinburgh, Det Forenede Kongerige, EH4 2XU
        • Ikke rekrutterer endnu
        • Research Site
      • London, Det Forenede Kongerige, SE5 9RS
        • Ikke rekrutterer endnu
        • Research Site
      • Manchester, Det Forenede Kongerige, M20 4BX
        • Ikke rekrutterer endnu
        • Research Site
  • Forenede Stater
    • Arizona
      • Gilbert, Arizona, Forenede Stater, 85234
        • Ikke rekrutterer endnu
        • Research Site
      • Phoenix, Arizona, Forenede Stater, 85054
        • Ikke rekrutterer endnu
        • Research Site
      • Tucson, Arizona, Forenede Stater, 85719
        • Ikke rekrutterer endnu
        • Research Site
    • California
      • Orange, California, Forenede Stater, 92868
        • Ikke rekrutterer endnu
        • Research Site
      • Santa Monica, California, Forenede Stater, 90404
        • Ikke rekrutterer endnu
        • Research Site
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Ikke rekrutterer endnu
        • Research Site
      • Denver, Colorado, Forenede Stater, 80218
        • Ikke rekrutterer endnu
        • Research Site
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Ikke rekrutterer endnu
        • Research Site
    • Florida
      • Coral Gables, Florida, Forenede Stater, 33156
        • Ikke rekrutterer endnu
        • Research Site
      • Tampa, Florida, Forenede Stater, 33606
        • Ikke rekrutterer endnu
        • Research Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Ikke rekrutterer endnu
        • Research Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60607
        • Ikke rekrutterer endnu
        • Research Site
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Ikke rekrutterer endnu
        • Research Site
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Ikke rekrutterer endnu
        • Research Site
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40207
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        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
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        • Research Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Ikke rekrutterer endnu
        • Research Site
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Ikke rekrutterer endnu
        • Research Site
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Ikke rekrutterer endnu
        • Research Site
    • New Jersey
      • East Brunswick, New Jersey, Forenede Stater, 08816
        • Ikke rekrutterer endnu
        • Research Site
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Ikke rekrutterer endnu
        • Research Site
      • New Hyde Park, New York, Forenede Stater, 11042
        • Ikke rekrutterer endnu
        • Research Site
      • New York, New York, Forenede Stater, 10029
        • Ikke rekrutterer endnu
        • Research Site
      • New York, New York, Forenede Stater, 10016
        • Ikke rekrutterer endnu
        • Research Site
      • New York, New York, Forenede Stater, 10032
        • Ikke rekrutterer endnu
        • Research Site
      • The Bronx, New York, Forenede Stater, 10467
        • Ikke rekrutterer endnu
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • Ikke rekrutterer endnu
        • Research Site
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Ikke rekrutterer endnu
        • Research Site
      • Durham, North Carolina, Forenede Stater, 27705
        • Ikke rekrutterer endnu
        • Research Site
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Ikke rekrutterer endnu
        • Research Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Ikke rekrutterer endnu
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45236
        • Ikke rekrutterer endnu
        • Research Site
      • Cleveland, Ohio, Forenede Stater, 44195
        • Ikke rekrutterer endnu
        • Research Site
      • Columbus, Ohio, Forenede Stater, 43210
        • Ikke rekrutterer endnu
        • Research Site
      • Montgomery, Ohio, Forenede Stater, 45242
        • Ikke rekrutterer endnu
        • Research Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Ikke rekrutterer endnu
        • Research Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Ikke rekrutterer endnu
        • Research Site
      • Nashville, Tennessee, Forenede Stater, 37219
        • Ikke rekrutterer endnu
        • Research Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Ikke rekrutterer endnu
        • Research Site
      • Houston, Texas, Forenede Stater, 77030
        • Ikke rekrutterer endnu
        • Research Site
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • Ikke rekrutterer endnu
        • Research Site
    • Washington
      • Puyallup, Washington, Forenede Stater, 98373
        • Ikke rekrutterer endnu
        • Research Site
      • Seattle, Washington, Forenede Stater, 98104
        • Ikke rekrutterer endnu
        • Research Site
      • Seattle, Washington, Forenede Stater, 98101
        • Ikke rekrutterer endnu
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Trukket tilbage
        • Research Site
  • Frankrig
      • Lille, Frankrig, 59037
        • Ikke rekrutterer endnu
        • Research Site
      • Nantes, Frankrig, 44093
        • Ikke rekrutterer endnu
        • Research Site
      • Paris, Frankrig, 75010
        • Ikke rekrutterer endnu
        • Research Site
      • Poitiers, Frankrig, 86021
        • Ikke rekrutterer endnu
        • Research Site
      • Toulouse, Frankrig, 31059
        • Ikke rekrutterer endnu
        • Research Site
  • Italien
      • Bologna, Italien, 40138
        • Ikke rekrutterer endnu
        • Research Site
      • Milan, Italien, 20141
        • Ikke rekrutterer endnu
        • Research Site
      • Milan, Italien, 20133
        • Ikke rekrutterer endnu
        • Research Site
      • Rome, Italien, 00168
        • Ikke rekrutterer endnu
        • Research Site
      • Rozzano, Italien, 20089
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        • Research Site
      • Torino, Italien, 10100
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        • Research Site
  • Japan
      • Fukuoka, Japan, 812-8582
        • Ikke rekrutterer endnu
        • Research Site
      • Kyoto, Japan, 602-8566
        • Ikke rekrutterer endnu
        • Research Site
      • Nishinomiya-shi, Japan, 663-8501
        • Ikke rekrutterer endnu
        • Research Site
      • Okayama, Japan, 700-8558
        • Ikke rekrutterer endnu
        • Research Site
      • Sapporo, Japan, 060-8648
        • Ikke rekrutterer endnu
        • Research Site
      • Shibuya-ku, Japan, 150-8935
        • Ikke rekrutterer endnu
        • Research Site
      • Shinjuku-ku, Japan, 160-8582
        • Ikke rekrutterer endnu
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Ikke rekrutterer endnu
        • Research Site
  • Polen
      • Gdansk, Polen, 80-952
        • Ikke rekrutterer endnu
        • Research Site
      • Gliwice, Polen, 44-101
        • Ikke rekrutterer endnu
        • Research Site
      • Kielce, Polen, 25-734
        • Ikke rekrutterer endnu
        • Research Site
      • Lublin, Polen, 20-090
        • Ikke rekrutterer endnu
        • Research Site
      • Poznan, Polen, 60-569
        • Ikke rekrutterer endnu
        • Research Site
      • Wroclaw, Polen, 50-367
        • Ikke rekrutterer endnu
        • Research Site
  • Spanien
      • Badalona, Spanien, 8916
        • Ikke rekrutterer endnu
        • Research Site
      • Barcelona, Spanien, 08036
        • Ikke rekrutterer endnu
        • Research Site
      • Madrid, Spanien, 28007
        • Ikke rekrutterer endnu
        • Research Site
      • Madrid, Spanien, 28041
        • Ikke rekrutterer endnu
        • Research Site
      • Pamplona, Spanien, 31008
        • Ikke rekrutterer endnu
        • Research Site
      • Salamanca, Spanien, 37007
        • Ikke rekrutterer endnu
        • Research Site
      • Seville, Spanien, 41013
        • Ikke rekrutterer endnu
        • Research Site
      • Valencia, Spanien, 46026
        • Ikke rekrutterer endnu
        • Research Site
  • Sverige
      • Gothenburg, Sverige, 413 45
        • Ikke rekrutterer endnu
        • Research Site
      • Huddinge, Sverige, 141 57
        • Ikke rekrutterer endnu
        • Research Site
      • Lund, Sverige, 22242
        • Ikke rekrutterer endnu
        • Research Site
  • Sydkorea
      • Seoul, Sydkorea, 3722
        • Ikke rekrutterer endnu
        • Research Site
      • Seoul, Sydkorea, 03080
        • Ikke rekrutterer endnu
        • Research Site
      • Seoul, Sydkorea, 06591
        • Ikke rekrutterer endnu
        • Research Site
      • Seoul, Sydkorea, 5505
        • Ikke rekrutterer endnu
        • Research Site
      • Seoul, Sydkorea, 06351
        • Ikke rekrutterer endnu
        • Research Site
  • Taiwan
      • Taipei, Taiwan, 10002
        • Ikke rekrutterer endnu
        • Research Site
      • Taipei, Taiwan, 112
        • Ikke rekrutterer endnu
        • Research Site
      • Taipei, Taiwan, 106
        • Ikke rekrutterer endnu
        • Research Site
      • Taoyuan, Taiwan, 33305
        • Ikke rekrutterer endnu
        • Research Site
  • Tyskland
      • Berlin, Tyskland, 13353
        • Ikke rekrutterer endnu
        • Research Site
      • Cologne, Tyskland, 50937
        • Ikke rekrutterer endnu
        • Research Site
      • Dresden, Tyskland, 01307
        • Ikke rekrutterer endnu
        • Research Site
      • Essen, Tyskland, 45122
        • Ikke rekrutterer endnu
        • Research Site
      • Freiburg im Breisgau, Tyskland, 79106
        • Ikke rekrutterer endnu
        • Research Site
      • Hamburg, Tyskland, 20246
        • Ikke rekrutterer endnu
        • Research Site
      • Kiel, Tyskland, 24105
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        • Research Site
      • Leipzig, Tyskland, 04103
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        • Research Site
      • Magdeburg, Tyskland, 39120
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        • Research Site
      • Mainz, Tyskland, 55131
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        • Research Site
      • München, Tyskland, 81675
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        • Research Site
      • Nuremberg, Tyskland, 90419
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        • Research Site
      • Würzburg, Tyskland, 97080
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        • Research Site

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

INCLUSION CRITERIA:

  1. Participants must be 18 years or older, at the time of signing the ICF.
  2. Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
  3. Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c)Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio.
  4. Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment.
  5. Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator.
  6. ECOG performance status Grade of 0 to 2.
  7. Participant must have adequate organ and bone marrow function.

EXCLUSION CRITERIA:

  1. Participant has active or prior CNS or meningeal involvement of MM.
  2. Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
  3. Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.
  4. Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.
  5. Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years.
  6. Participant has a history of haematologic malignancies, other than MM, regardless of remission status.

  7. Participant is positive for any of the following:

    1. HIV: Known to be seropositive for HIV (including any history of HIV).
    2. Chronic or active hepatitis B.
    3. Active hepatitis C: Hepatitis C infection.
    4. Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations.
  8. Participant has clinically significant cardiovascular disease.
  9. Participant has COPD with an FEV1 < 50% of predicted normal.
  10. Additional exclusion for participants who are planned to receive IsaVRd as induction: Participant has peripheral neuropathy Grade 4, Grade 3, Grade 2, or Grade 1 with pain.

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: Arm A: Investigational Arm
Arm A is the sequence of induction with IsaVRd or DRd, apheresis, optional bridging therapy, lymphodepletion (cyclophosphamide and fludarabine), and AZD0120.
Medicin: Cyclofosfamid
Lymfodepletion
Medicin: Fludarabin
Lymfodepletion
Biologisk: AZD0120
AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.
Biologisk: Daratumumab
Induction, optional bridging and continuous therapy.
Medicin: Dexamethasone
Induction, optional bridging and continuous therapy.
Biologisk: Isatuximab
Induction, optional bridging and continuous therapy.
Medicin: Lenalidomide
Induction, optional bridging and continuous therapy.
Medicin: Bortezomib
Induction therapy.
Aktiv komparator: Arm B: Control Arm
Arm B is the standard therapy induction with IsaVRd or DRd, followed by continuous IsaRd or DRd until disease progression or intolerable toxicity.
Biologisk: Daratumumab
Induction, optional bridging and continuous therapy.
Medicin: Dexamethasone
Induction, optional bridging and continuous therapy.
Biologisk: Isatuximab
Induction, optional bridging and continuous therapy.
Medicin: Lenalidomide
Induction, optional bridging and continuous therapy.
Medicin: Bortezomib
Induction therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PFS in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd.
Tidsramme: Up to 9 years.
PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first.
Up to 9 years.
MRD negative CR rate at 9M in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd
Tidsramme: Up to 9 years.
MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status (at threshold of 10-5) and have a response of CR or sCR (according to the IMWG 2016 criteria) as assessed by BICR at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
Up to 9 years.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete Response Rate
Tidsramme: Up to 9 years.
The proportion of participants who achieved CR or better according to IMWG 2016 criteria, as assessed by BICR
Up to 9 years.
Overall Survival
Tidsramme: Up to 9 years.
Time from randomisation until date of death due to any cause
Up to 9 years.
Number and percentage of participants with adverse events as graded by CTCAE v6 and ASTCT Consensus Grading criteria
Tidsramme: Up to 9 years.
Adverse Event Incidence
Up to 9 years.
Concentration of Circulating CAR-T+ Cells in Peripheral Blood
Tidsramme: Up to 9 years.
Quantification of circulating CAR-T+ cell levels by measuring CAR transgene in peripheral blood and CK parameters of AZD0120 will be measured to characterise the cellular kinetics of AZD0120 in blood.
Up to 9 years.
Number and percentage of participants with incidence of ADAs against AZD0120
Tidsramme: Up to 9 years.
Assessment humoral immunogenicity of AZ0120 based on incidence of ADAs.
Up to 9 years.
Patient Reported Outcomes
Tidsramme: Up to 9 years.
Change from baseline in bone pain severity measured by the European Organisation for Research and Treatment of Cancer Item Library 469 single bone pain item (EORTC IL469 - score range 0 - 100, with higher scores indicating worse bone pain) in participants with newly diagnosed multiple myeloma ineligible for autologous stem cell transplantation as initial therapy.
Up to 9 years.
Patient Reported Outcomes
Tidsramme: Up to 9 years.
Change from baseline in fatigue severity, physical functioning, and global health status/quality of life measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 fatigue, physical functioning, and global health status/quality of life scales (EORTC QLQ-C30 - score range 0 to 100; higher scores indicate worse fatigue, better physical functioning, and better general health status/quality of life) in participants with newly diagnosed multiple myeloma ineligible for autologous stem cell transplantation as initial therapy.
Up to 9 years.
Overall Response Rate
Tidsramme: Up to 9 years
Proportion of participants who achieved PR or better according to IMWG 2016 criteria
Up to 9 years
Duration of Response
Tidsramme: Up to 9 years
Time from first documented confirmed response (PR or better) until date of documented PD per IMWG 2016 criteria or death due to any cause, whichever occurs first.
Up to 9 years
Time to Response
Tidsramme: Up to 9 years
Time from randomisation until the date of first documented objective response (PR or better), as assessed per IMWG 2016 criteria.
Up to 9 years
MRD negative CR rate
Tidsramme: Up to 9 years
Proportion of participants who have MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at any time after the date of randomisation and before initiation of subsequent therapy.
Up to 9 years
Rate of sustained MRD negative CR
Tidsramme: Up to 9 years
Proportion of participants who have achieved MRD negative status and have a response of CR or sCR
Up to 9 years
Progression Free Survival 2 (PFS2)
Tidsramme: Up to 9 years
Time from randomisation to progression on next line of therapy, as assessed by Investigator, or death due to any cause, whichever occurs first
Up to 9 years

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Efterforskere

  • Studieleder: Jen Brudno, MD, AstraZeneca

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)

26. juni 2026

Primær færdiggørelse (Anslået)

11. januar 2029

Studieafslutning (Anslået)

12. maj 2034

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

10. august 2026

Først opslået (Faktiske)

14. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D8312C00002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD-delingstidsramme

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD-delingsadgangskriterier

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 .

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