A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4) (DURGA-4)

August 31, 2026 updated by: AstraZeneca

A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CART) Therapy Directed Against BCMA and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma.

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd [daratumumab, carfilzomib, and dexamethasone], DPd [daratumumab, pomalidomide, and dexamethasone], PVd [pomalidomide, bortezomib and dexamethasone], or Kd [carfilzomib and dexamethasone]) in participants with RRMM.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
508

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Camperdown, Australia, 2050
        • Recruiting
        • Research Site
      • Darlinghurst, Australia, 2010
        • Recruiting
        • Research Site
      • Fitzroy, Australia, VIC3065
        • Recruiting
        • Research Site
      • Liverpool, Australia, 2170
        • Not yet recruiting
        • Research Site
      • Melbourne, Australia, 3000
        • Recruiting
        • Research Site
      • Melbourne, Australia, 3004
        • Recruiting
        • Research Site
      • Murdoch, Australia, WA6150
        • Not yet recruiting
        • Research Site
  • Brazil
      • Salvador, Brazil, 41253-190
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 05652-900
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 01509-900
        • Recruiting
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Not yet recruiting
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Not yet recruiting
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Recruiting
        • Research Site
  • China
      • Beijing, China, 100044
        • Not yet recruiting
        • Research Site
      • Beijing, China, 100024
        • Not yet recruiting
        • Research Site
      • Changchun, China, 130021
        • Not yet recruiting
        • Research Site
      • Changsha, China, 410013
        • Not yet recruiting
        • Research Site
      • Changsha, China, 410008
        • Not yet recruiting
        • Research Site
      • Chongqing, China, 400030
        • Not yet recruiting
        • Research Site
      • Guangzhou, China, 510000
        • Not yet recruiting
        • Research Site
      • Guangzhou, China, 510700
        • Not yet recruiting
        • Research Site
      • Hefei, China, 230601
        • Not yet recruiting
        • Research Site
      • Nanchang, China, 330006
        • Not yet recruiting
        • Research Site
      • Nanchang, China, 330000
        • Not yet recruiting
        • Research Site
      • Nanjing, China, 210000
        • Not yet recruiting
        • Research Site
      • Ningbo, China, 315040
        • Not yet recruiting
        • Research Site
      • Shanghai, China, 200025
        • Not yet recruiting
        • Research Site
      • Shanghai, China, 201210
        • Not yet recruiting
        • Research Site
      • Shanghai, China, 200065
        • Not yet recruiting
        • Research Site
      • Shenzhen, China, 518039
        • Not yet recruiting
        • Research Site
      • Tianjin, China, 300020
        • Not yet recruiting
        • Research Site
      • Wenzhou, China, 325000
        • Not yet recruiting
        • Research Site
      • Wuhan, China, 430030
        • Not yet recruiting
        • Research Site
      • Xi'an, China, 710061
        • Not yet recruiting
        • Research Site
      • Xi'an, China, 710004
        • Not yet recruiting
        • Research Site
      • Zhengzhou, China, 450000
        • Not yet recruiting
        • Research Site
      • Zhengzhou, China, 450008
        • Not yet recruiting
        • Research Site
  • France
      • Lille, France, 59037
        • Not yet recruiting
        • Research Site
      • Nantes, France, 44093
        • Not yet recruiting
        • Research Site
      • Paris, France, 75010
        • Not yet recruiting
        • Research Site
      • Pierre-Bénite, France, 69495
        • Not yet recruiting
        • Research Site
      • Poitiers, France, 86021
        • Not yet recruiting
        • Research Site
      • Toulouse, France, 31059
        • Not yet recruiting
        • Research Site
  • Germany
      • Berlin, Germany, 12200
        • Not yet recruiting
        • Research Site
      • Dresden, Germany, 01307
        • Not yet recruiting
        • Research Site
      • Erlangen, Germany, 91054
        • Not yet recruiting
        • Research Site
      • Essen, Germany, 45147
        • Not yet recruiting
        • Research Site
      • Freiburg im Breisgau, Germany, 79106
        • Not yet recruiting
        • Research Site
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Research Site
      • Leipzig, Germany, 04103
        • Not yet recruiting
        • Research Site
      • Mainz, Germany, 55131
        • Not yet recruiting
        • Research Site
      • München, Germany, 81675
        • Not yet recruiting
        • Research Site
      • Nuremberg, Germany, 90419
        • Not yet recruiting
        • Research Site
      • Würzburg, Germany, 97080
        • Not yet recruiting
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Not yet recruiting
        • Research Site
      • Milan, Italy, 20133
        • Not yet recruiting
        • Research Site
      • Milan, Italy, 20132
        • Not yet recruiting
        • Research Site
      • Naples, Italy, 80131
        • Not yet recruiting
        • Research Site
      • Rozzano, Italy, 20089
        • Not yet recruiting
        • Research Site
      • Torino, Italy, 10100
        • Not yet recruiting
        • Research Site
  • Japan
      • Bunkyō City, Japan, 113-8431
        • Recruiting
        • Research Site
      • Kashiwa, Japan, 277-8577
        • Recruiting
        • Research Site
      • Kyoto, Japan, 602-8566
        • Recruiting
        • Research Site
      • Nagoya, Japan, 467-8602
        • Recruiting
        • Research Site
      • Shibuya-ku, Japan, 150-8935
        • Recruiting
        • Research Site
      • Shinjuku-ku, Japan, 160-8582
        • Recruiting
        • Research Site
  • Norway
      • Oslo, Norway, 0450
        • Not yet recruiting
        • Research Site
  • Poland
      • Gdansk, Poland, 80-952
        • Not yet recruiting
        • Research Site
      • Gliwice, Poland, 44-101
        • Not yet recruiting
        • Research Site
      • Lublin, Poland, 20-090
        • Not yet recruiting
        • Research Site
      • Poznan, Poland, 60-569
        • Not yet recruiting
        • Research Site
      • Warsaw, Poland, 02-776
        • Not yet recruiting
        • Research Site
      • Wroclaw, Poland, 50-367
        • Not yet recruiting
        • Research Site
  • South Korea
      • Seoul, South Korea, 03080
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 06591
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 5505
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 06351
        • Not yet recruiting
        • Research Site
  • Spain
      • Barcelona, Spain, 08036
        • Not yet recruiting
        • Research Site
      • Barcelona, Spain, 8035
        • Not yet recruiting
        • Research Site
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Research Site
      • Pamplona, Spain, 31008
        • Not yet recruiting
        • Research Site
      • Salamanca, Spain, 37007
        • Not yet recruiting
        • Research Site
      • Santander, Spain, 39008
        • Not yet recruiting
        • Research Site
      • Valencia, Spain, 46026
        • Not yet recruiting
        • Research Site
  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 10002
        • Not yet recruiting
        • Research Site
      • Taipei, Taiwan, 106
        • Recruiting
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Recruiting
        • Research Site
      • Bristol, United Kingdom, BS2 8ED
        • Recruiting
        • Research Site
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Not yet recruiting
        • Research Site
      • London, United Kingdom, SM2 5NG
        • Recruiting
        • Research Site
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Not yet recruiting
        • Research Site
      • Phoenix, Arizona, United States, 85054
        • Withdrawn
        • Research Site
      • Tucson, Arizona, United States, 85719
        • Not yet recruiting
        • Research Site
    • California
      • La Jolla, California, United States, 92093
        • Withdrawn
        • Research Site
      • Sacramento, California, United States, 95817
        • Not yet recruiting
        • Research Site
      • Santa Monica, California, United States, 90404
        • Not yet recruiting
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Not yet recruiting
        • Research Site
    • Florida
      • Coral Gables, Florida, United States, 33156
        • Withdrawn
        • Research Site
      • Tampa, Florida, United States, 33606
        • Not yet recruiting
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Research Site
      • Park Ridge, Illinois, United States, 60068
        • Not yet recruiting
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Withdrawn
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Withdrawn
        • Research Site
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Research Site
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Withdrawn
        • Research Site
      • Detroit, Michigan, United States, 48202
        • Withdrawn
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Withdrawn
        • Research Site
    • New York
      • Albany, New York, United States, 12208
        • Not yet recruiting
        • Research Site
      • New York, New York, United States, 10065
        • Withdrawn
        • Research Site
      • New York, New York, United States, 10065
        • Recruiting
        • Research Site
      • New York, New York, United States, 10029
        • Recruiting
        • Research Site
      • New York, New York, United States, 10016
        • Withdrawn
        • Research Site
      • Rochester, New York, United States, 14642
        • Withdrawn
        • Research Site
      • The Bronx, New York, United States, 10467
        • Withdrawn
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Not yet recruiting
        • Research Site
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Research Site
      • Charlotte, North Carolina, United States, 28204
        • Not yet recruiting
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Research Site
      • Winston-Salem, North Carolina, United States, 27157
        • Not yet recruiting
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Not yet recruiting
        • Research Site
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Withdrawn
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Research Site
    • Texas
      • Austin, Texas, United States, 78704
        • Recruiting
        • Research Site
      • Dallas, Texas, United States, 75235
        • Not yet recruiting
        • Research Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Not yet recruiting
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Withdrawn
        • Research Site
      • Gainesville, Virginia, United States, 20155
        • Not yet recruiting
        • Research Site
      • Richmond, Virginia, United States, 23298
        • Withdrawn
        • Research Site
    • Washington
      • Puyallup, Washington, United States, 98373
        • Not yet recruiting
        • Research Site
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • Research Site
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria

  • Documented evidence of measurable disease:

    1. Serum M-protein level ≥ 1 g/dL
    2. Urine M-protein level ≥ 200 mg/24h
    3. Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy
  • Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy
  • Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.
  • ECOG performance status score of 0 to 1

  • Adequate hematology and chemistry laboratory values:

    1. Haemoglobin ≥ 8.0 g/dL
    2. Absolute neutrophil count ≥ 1 × 10^9/L (1000 per mm3)
    3. Platelet count ≥ 75 × 10^9/L (75000 per mm3) in participants with < 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells
    4. Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)
    5. Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute

Exclusion Criteria:

  • Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
  • Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.
  • Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)
  • Significant neurological or psychiatric condition
  • Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
  • Previously received any prior BCMA-targeted treatment
  • Previously received CAR-T or CAR-NK therapy directed at any target
  • Previously received T-cell engager therapy directed at any target
  • Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
AZD0120
Biological: AZD0120
CAR-T Cells
Active Comparator: Arm B
1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd.
Drug: Dexamethasone
Dexamethasone
Drug: Bortezomib
Bortezomib
Other Names:
  • Velcade
Drug: Carfilzomib
Carfilzomib
Other Names:
  • Kyprolis
Drug: Daratumumab
Daratumumab
Other Names:
  • Darzalex
Drug: Pomalidomide
Pomalidomides
Other Names:
  • Pomalyst and Imnovid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM.
Time Frame: 3 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.
3 years
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negativity rate at 9 months in participants with RRMM.
Time Frame: 2 years
MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of CRR in participants with RRMM.
Time Frame: 2 years
2 years
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of ORR in participants with RRMM.
Time Frame: 2 years
2 years
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of OS in participants with RRMM.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D8311C00001
  • AZD0120 (Other Identifier: AstraZeneca)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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 rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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