Newly Diagnosed Multiple Myeloma (NDMM)Phase 3DURGA-6NCT07735637

A Phase III, Multicentre Study to Evaluate Consolidation Treatment With AZD0120 Compared With ASCT, in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (DURGA-6).

A Phase 3 study testing AZD0120, Cyclophosphamide and Fludarabine in people with Newly Diagnosed Multiple Myeloma (NDMM), run by AstraZeneca at 114 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The purpose of this study is to measure the efficacy of AZD0120 compared with ASCT in terms of progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) criteria 2016, and MRD negative complete response (CR) rate at 9 months as assessed by Blinded Independent Central Review (BICR), in… Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Newly Diagnosed Multiple Myeloma (NDMM)
What is being tested?: AZD0120, Cyclophosphamide and Fludarabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 750 participants
Where: 114 sitesin 18 countries
Study dates: 24 Sep 2026to 17 Nov 2039
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥18 years of age.
Documented diagnosis of NDMM according to IMWG diagnostic criteria.
Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio)
Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd
Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation.
ECOG performance status score of 0 or 1.
Eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT.
Adequate organ and bone marrow function.

Who cannot join

Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
Primary amyloidosis, active plasma cell leukaemia (at diagnosis and/or at time of screening), Waldenstrom macroglobulinemia or POEMS syndrome.
Significant neurological or psychiatric condition
Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
Participants who required the introduction of an additional agent therapy due to inadequate response.
Prior T-cell engager therapy directed at any target.
Prior CAR-T and/or CAR-NK cell therapy directed at any target for any indications
Prior any therapy that is targeted to BCMA and CD19.

Trial locations and contacts

114 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

114 sites in 18 countries

United States46 sites, 43 recruiting

Research Site
Atlanta, Georgia, 30322
Not yet recruiting
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Atlanta, Georgia, 30342
Not yet recruiting
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Austin, Texas, 78704
Not yet recruiting
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Boston, Massachusetts, 02118
Not yet recruiting
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Boston, Massachusetts, 02215
Not yet recruiting
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Chapel Hill, North Carolina, 27514
Not yet recruiting
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Charlotte, North Carolina, 28204
Not yet recruiting
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Charlottesville, Virginia, 22908
Not yet recruiting
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Chicago, Illinois, 60637
Not yet recruiting
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Cleveland, Ohio, 44195
Not yet recruiting
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Columbus, Ohio, 43210
Not yet recruiting
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Dallas, Texas, 75235
Not yet recruiting
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Denver, Colorado, 80218
Not yet recruiting
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Detroit, Michigan, 48201
Not yet recruiting
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Durham, North Carolina, 27705
Not yet recruiting
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Gilbert, Arizona, 85234
Not yet recruiting
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Goodyear, Arizona, 85338
Not yet recruiting
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Great Neck, New York, 11021
Not yet recruiting
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Houston, Texas, 77030
Not yet recruiting
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Jacksonville, Florida, 32224
Not yet recruiting
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Lexington, Kentucky, 40536
Not yet recruiting
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Los Angeles, California, 90095
Withdrawn
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Madison, Wisconsin, 53792
Not yet recruiting
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Milwaukee, Wisconsin, 53226
Not yet recruiting
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New York, New York, 10021
Not yet recruiting
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New York, New York, 10029
Not yet recruiting
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New York, New York, 10032
Not yet recruiting
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Newnan, Georgia, 30265
Not yet recruiting
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Orange, California, 92868
Not yet recruiting
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Philadelphia, Pennsylvania, 19104
Not yet recruiting
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Philadelphia, Pennsylvania, 19107
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Phoenix, Arizona, 85028
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Portland, Oregon, 97239
Not yet recruiting
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Rochester, Minnesota, 55905
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Rochester, New York, 14642
Not yet recruiting
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San Antonio, Texas, 78229
Not yet recruiting
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San Francisco, California, 94110
Not yet recruiting
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Seattle, Washington, 98104
Withdrawn
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Seattle, Washington, 98109
Withdrawn
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St Louis, Missouri, 63110
Not yet recruiting
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Stanford, California, 94305-5824
Not yet recruiting
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Stony Brook, New York, 11794
Not yet recruiting
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Tampa, Florida, 33612
Not yet recruiting
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The Bronx, New York, 10467
Not yet recruiting
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Winston-Salem, North Carolina, 27103
Not yet recruiting
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Zion, Illinois, 60099
Not yet recruiting

Other trials in United States

Australia8 sites, 7 recruiting

Research Site
Brisbane, 4102
Not yet recruiting
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Camperdown, 2050
Not yet recruiting
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Darlinghurst, 2010
Not yet recruiting
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East Melbourne, 3002
Not yet recruiting
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Fitzroy, 3065
Recruiting
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Melbourne, 3004
Withdrawn
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Nedlands, 6009
Not yet recruiting
Research Site
Westmead, 2145
Not yet recruiting

Other trials in Australia

Germany8 sites, 8 recruiting

Research Site
Berlin, 10117
Not yet recruiting
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Dresden, 01307
Not yet recruiting
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Essen, 45122
Not yet recruiting
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Freiburg im Breisgau, 79106
Not yet recruiting
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Hamburg, 20246
Not yet recruiting
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Leipzig, 04103
Not yet recruiting
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München, 81675
Not yet recruiting
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Oldenburg, 26133
Not yet recruiting

Other trials in Germany

Spain7 sites, 7 recruiting

Research Site
Badalona, 08916
Not yet recruiting
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Barcelona, 08035
Not yet recruiting
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El Palmar, 30120
Not yet recruiting
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Madrid, 28034
Not yet recruiting
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Salamanca, 37007
Not yet recruiting
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Santander, 39008
Not yet recruiting
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Seville, 41013
Not yet recruiting

Other trials in Spain

Italy6 sites, 6 recruiting

Research Site
Bologna, 40138
Not yet recruiting
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Milan, 20133
Not yet recruiting
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Milan, 20141
Not yet recruiting
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Rome, 00168
Not yet recruiting
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Rozzano, 20089
Not yet recruiting
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Torino, 10100
Not yet recruiting

Other trials in Italy

Poland6 sites, 6 recruiting

Research Site
Gdansk, 80-214
Not yet recruiting
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Gliwice, 44-100
Not yet recruiting
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Kielce, 25-734
Not yet recruiting
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Krakow, 30-688
Not yet recruiting
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Lublin, 20-090
Not yet recruiting
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Wroclaw, 50-556
Not yet recruiting

Other trials in Poland

France5 sites, 5 recruiting

Research Site
Lille, 59037
Not yet recruiting
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Nantes, 44093
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Paris, 75012
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Paris, 75475
Not yet recruiting
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Toulouse, 31059
Not yet recruiting

Other trials in France

Canada4 sites, 4 recruiting

Research Site
Calgary, Alberta, T2N 5G2
Not yet recruiting
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Halifax, Nova Scotia, B3H 2Y9
Not yet recruiting
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Montreal, Quebec, H3T 1E2
Not yet recruiting
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Sherbrooke, Quebec, J1G 2K7
Not yet recruiting

Other trials in Canada

South Korea4 sites, 4 recruiting

Research Site
Seoul, 03080
Not yet recruiting
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Seoul, 06351
Not yet recruiting
Research Site
Seoul, 06591
Not yet recruiting
Research Site
Seoul, 5505
Not yet recruiting

Other trials in South Korea

Taiwan4 sites, 4 recruiting

Research Site
Taipei, 10002
Not yet recruiting
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Taipei, 106
Not yet recruiting
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Taipei, 112
Not yet recruiting
Research Site
Taoyuan, 333
Not yet recruiting

Other trials in Taiwan

Brazil3 sites, 3 recruiting

Research Site
Salvador, 41253-190
Not yet recruiting
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São Paulo, 01509-900
Not yet recruiting
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São Paulo, 05652-900
Not yet recruiting

Other trials in Brazil

Denmark3 sites, 3 recruiting

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Aarhus, 8200
Not yet recruiting
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København Ø, 2100
Not yet recruiting
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Odense, 5464
Not yet recruiting

Other trials in Denmark

China2 sites, 2 recruiting

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Beijing, 100044
Not yet recruiting
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Shanghai, 201210
Not yet recruiting

Other trials in China

Saudi Arabia2 sites, 2 recruiting

Research Site
Riyadh, 11211
Not yet recruiting
Research Site
Riyadh, 11426
Not yet recruiting

Other trials in Saudi Arabia

Singapore2 sites, 2 recruiting

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Singapore, 119074
Not yet recruiting
Research Site
Singapore, 169608
Not yet recruiting

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United Kingdom2 sites, 2 recruiting

Research Site
Cambridge, CB2 0QQ
Not yet recruiting
Research Site
London, W12 0HS
Recruiting

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Japan1 site, 1 recruiting

Research Site
Nagoya, 467-8602
Not yet recruiting

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Norway1 site, 1 recruiting

Research Site
Oslo, 0450
Not yet recruiting

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About this study

Official title: A Phase III, Open-label, Multicentre, Randomised Study Comparing Consolidation Treatment With AZD0120, an Autologous Dual Targeting Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, Versus Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (TE NDMM) (DURGA-6)

Study details include:

The study duration is estimated to be up to 13 years from the date the first participant is randomised.
For participants in Arm A (AZD0120), the total duration of participant follow-up will be 15 years (including a Long Term Follow-up study) after the last participant has received the AZD0120 infusion.
The treatment duration will be:- Arm A (AZD0120): lymphodepletion over 3 days, a single-day infusion of AZD0120, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment.
Arm B (ASCT): conditioning therapy over 24 to 48 hours, ASCT, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment.

Disclosure Statement: This is an open-label, randomised study with 2 treatment arms.

Conditions: Newly Diagnosed Multiple Myeloma (NDMM)
Being tested: AZD0120, Cyclophosphamide, Fludarabine, Melphalan (part of ASCT), Lenalidomide
Keywords: Multiple Myeloma, NDMM, AZD0120, cell therapy, CAR-T, DURGA-6, BCMA, CD19, transplant eligible
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD0120Biological
Arm A: AZD0120 - autologous BCMA/CD19 dual-targeting CAR-T cells. Participants will receive lymphodepletion conditioning (cyclophosphamide and fludarabine) followed by AZD0120 CAR-T cell infusion.
CyclophosphamideDrug
Arm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning.
FludarabineDrug
Arm A: Fludarabine will be given intravenously as lymphodepletion conditioning.
Melphalan (part of ASCT)Drug
Arm B - Autologous stem cell transplant: High-dose melphalan will be given over 1-2 days, followed by autologous stem cell rescue.
LenalidomideDrug
Arm A and Arm B: Lenalidomide maintenance treatment will be started in both Arm A and Arm B after AZD0120 therapy or ASCT, respectively. Lenalidomide maintenance on study will be continued up to 2 years.

Study groups in NCT07735637
Study group	Role	What they receive
Arm A: AZD0120	Experimental	AZD0120 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy. Receives: Biological: AZD0120; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Lenalidomide
Arm B: Autologous Stem Cell Transplant (ASCT)	Active comparator	ASCT: High-dose melphalan followed by autologous stem cell rescue Receives: Drug: Melphalan (part of ASCT); Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS)
PFS is defined as time from randomisation until progression as assessed by Blinded Independent Central Review, or death due to any cause, whichever occurs first.
Measured: Up to approximately 13 years.
Minimal Residual Disease (MRD) negative Complete Response Rate (CRR)
MRD negative CRR is defined as the proportion of participants with a MRD negative status and who have a response of CR or a stringent CR.
Measured: Up to approximately 13 years.

Secondary outcomes (6)

Secondary: Overall Survival (OS)
OS is defined as time from randomisation until date of death due to any cause.
Measured: Up to approximately 13 years.
Secondary: Complete Response Rate (CRR)
CRR (CR or stringent CR rate) is defined as the proportion of participants who achieved CR or better and as assessed by Blinded Independent Central Review.
Measured: Up to approximately 13 years.
Secondary: Overall Response Rate (ORR)
ORR is defined as the proportion of participants with a response (complete, partial or very good partial response) as assessed by Blinded Independent Central Review.
Measured: Up to approximately 13 years.
Secondary: Duration of Response (DoR)
DoR is defined as the time from first response to progression or death
Measured: Up to approximately 13 years.
Other secondary: Time to Response (TTR)
TTR is defined as the time from randomisation to first response
Measured: Up to approximately 13 years.
Safety - Adverse Events
To evaluate safety in terms of the number of participants experiencing an Adverse Event.
Measured: Up to approximately 13 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 202617 Nov 2039

First posted30 Jul 2026
Study start24 Sep 2026
Primary completion2 Nov 2028 (estimated)
Study completion17 Nov 2039 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Newly Diagnosed Multiple Myeloma (NDMM)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 750 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07735637
Sponsor's protocol ID: D8316C00001
Other IDs: AZD0120
Acronym: DURGA-6
Status last verified: Oct 2026
First submitted: 22 Jul 2026
Last updated: 21 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Newly Diagnosed Multiple Myeloma (NDMM) trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Open-label, Multicentre, Randomised Study Comparing Consolidation Treatment With AZD0120, an Autologous Dual Targeting Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, Versus Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (TE NDMM) (DURGA-6)
ClinicalTrials.gov ID: NCT07735637
Acronym / sponsor ID: DURGA-6 / D8316C00001
Conditions: Newly Diagnosed Multiple Myeloma (NDMM)
Keywords: Multiple Myeloma, NDMM, AZD0120, cell therapy, CAR-T, DURGA-6, BCMA, CD19
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 750 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 24 Sep 2026 (actual)
Primary completion: 2 Nov 2028 (estimated)
Study completion: 17 Nov 2039 (estimated)
First posted: 30 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study details include:

The study duration is estimated to be up to 13 years from the date the first participant is randomised.
For participants in Arm A (AZD0120), the total duration of participant follow-up will be 15 years (including a Long Term Follow-up study) after the last participant has received the AZD0120 infusion.
The treatment duration will be:- Arm A (AZD0120): lymphodepletion over 3 days, a single-day infusion of AZD0120, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment.
Arm B (ASCT): conditioning therapy over 24 to 48 hours, ASCT, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment.

Disclosure Statement: This is an open-label, randomised study with 2 treatment arms.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A: AZD0120	Experimental	Biological: AZD0120, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: LenalidomideAZD0120 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy.
Arm B: Autologous Stem Cell Transplant (ASCT)	Active comparator	Drug: Melphalan (part of ASCT), Drug: LenalidomideASCT: High-dose melphalan followed by autologous stem cell rescue

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

≥18 years of age.
Documented diagnosis of NDMM according to IMWG diagnostic criteria.
Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio)
Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd
Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation.

Key exclusion criteria (8 listed)

Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
Primary amyloidosis, active plasma cell leukaemia (at diagnosis and/or at time of screening), Waldenstrom macroglobulinemia or POEMS syndrome.
Significant neurological or psychiatric condition
Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
Participants who required the introduction of an additional agent therapy due to inadequate response.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD0120Arm A: AZD0120 - autologous BCMA/CD19 dual-targeting CAR-T cells. Participants will receive lymphodepletion conditioning (cyclophosphamide and fludarabine) followed by AZD0120 CAR-T cell infusion.	Biological	Arm A: AZD0120
CyclophosphamideArm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning.	Drug	Arm A: AZD0120
FludarabineArm A: Fludarabine will be given intravenously as lymphodepletion conditioning.	Drug	Arm A: AZD0120
Melphalan (part of ASCT)Arm B - Autologous stem cell transplant: High-dose melphalan will be given over 1-2 days, followed by autologous stem cell rescue.	Drug	Arm B: Autologous Stem Cell Transplant (ASCT)
LenalidomideArm A and Arm B: Lenalidomide maintenance treatment will be started in both Arm A and Arm B after AZD0120 therapy or ASCT, respectively. Lenalidomide maintenance on study will be continued up to 2 years.	Drug	Arm A: AZD0120, Arm B: Autologous Stem Cell Transplant (ASCT)

Primary outcome

Progression-Free Survival (PFS)
Time frame: Up to approximately 13 years.
PFS is defined as time from randomisation until progression as assessed by Blinded Independent Central Review, or death due to any cause, whichever occurs first.
Minimal Residual Disease (MRD) negative Complete Response Rate (CRR)
Time frame: Up to approximately 13 years.
MRD negative CRR is defined as the proportion of participants with a MRD negative status and who have a response of CR or a stringent CR.

6 secondary outcomes

Secondary: Overall Survival (OS)
Time frame: Up to approximately 13 years.
Secondary: Complete Response Rate (CRR)
Time frame: Up to approximately 13 years.
Secondary: Overall Response Rate (ORR)
Time frame: Up to approximately 13 years.
Secondary: Duration of Response (DoR)
Time frame: Up to approximately 13 years.
Other secondary: Time to Response (TTR)
Time frame: Up to approximately 13 years.
Safety - Adverse Events
Time frame: Up to approximately 13 years.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
Individual participant dataSharing planned: Yes. 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.

Related trials for Newly Diagnosed Multiple Myeloma (NDMM)

RecruitingPhase 2
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Less Doses of Daratumumab Are Adequate to Achieve Response in Newly Diagnosed Multiple Myeloma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

114 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZD0120, Cyclophosphamide and Fludarabine in people with Newly Diagnosed Multiple Myeloma (NDMM), run by AstraZeneca at 114 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Australia, Germany, Spain, Italy and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to approximately 13 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07735637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.