Untreated Follicular LymphomaPhase 3NCT06549595

A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

A Phase 3 study testing Surovatamig, R-CHOP and R-CVP in people with Untreated Follicular Lymphoma, run by AstraZeneca at 244 sites in 25 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

This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Untreated Follicular Lymphoma
What is being tested?: Surovatamig, R-CHOP and R-CVP
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,018 participants
Where: 244 sitesin 25 countries
Study dates: 7 Aug 2024to 26 Nov 2031
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

Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
Histologically confirmed diagnosis of classic FL per WHO 2022 classification
ECOG performance status of 0 to 2
No prior systemic lymphoma-directed therapy
Need for systemic treatment meeting at least 1 GELF criteria
FDG-avid and measurable disease

Show all 9Show fewer

Stage II to IV and FLIPI 2-5 [Phase III only]
Adequate liver, hematological, renal and cardiac function.
The above is a summary, other inclusion criteria details may apply

Who cannot join

Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
Contra-indication to BR, RCVP, and R-CHOP
Participants with or history of CNS lymphoma
History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety
Presence of >5000 circulating lymphoma cells
Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment
Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
The above is a summary, other exclusion criteria details may apply

Trial locations and contacts

244 sites in 25 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

244 sites in 25 countries

United States63 sites, 60 recruiting

Research Site
Albany, New York, 12206
Recruiting
Research Site
Anchorage, Alaska, 99508
Recruiting
Research Site
Ann Arbor, Michigan, 48109
Not yet recruiting
Research Site
Atlanta, Georgia, 30322
Not yet recruiting
Research Site
Aurora, Colorado, 80045
Withdrawn
Research Site
Austin, Texas, 78705
Not yet recruiting
Research Site
Baltimore, Maryland, 21201
Not yet recruiting
Research Site
Baton Rouge, Louisiana, 70808
Not yet recruiting
Research Site
Bethesda, Maryland, 20817
Recruiting
Research Site
Blue Ash, Ohio, 45242
Not yet recruiting
Research Site
Boston, Massachusetts, 02114
Not yet recruiting
Research Site
Boston, Massachusetts, 02215
Not yet recruiting
Research Site
Brooklyn, New York, 11220
Not yet recruiting
Research Site
Charlotte, North Carolina, 28204
Not yet recruiting
Research Site
Charlotte, North Carolina, 28204
Recruiting
Research Site
Chesterfield, Missouri, 63017
Not yet recruiting
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Cincinnati, Ohio, 45219
Not yet recruiting
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Clovis, California, 93611
Not yet recruiting
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Columbia, Maryland, 21044
Not yet recruiting
Research Site
Columbus, Ohio, 43210
Not yet recruiting
Research Site
Des Moines, Iowa, 50309
Not yet recruiting
Research Site
Detroit, Michigan, 48201
Withdrawn
Research Site
Eugene, Oregon, 97401
Not yet recruiting
Research Site
Evanston, Illinois, 60201
Not yet recruiting
Research Site
Fairfax, Virginia, 22031
Not yet recruiting
Research Site
Fort Wayne, Indiana, 46804
Recruiting
Research Site
Hackensack, New Jersey, 07601
Not yet recruiting
Research Site
Huntsville, Alabama, 35805
Recruiting
Research Site
Iowa City, Iowa, 52242
Not yet recruiting
Research Site
Jacksonville, Florida, 32224
Recruiting
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Lexington, Kentucky, 40536
Not yet recruiting
Research Site
Los Alamitos, California, 90720
Recruiting
Research Site
Louisville, Kentucky, 40207
Not yet recruiting
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Lubbock, Texas, 79430
Not yet recruiting
Research Site
Macon, Georgia, 31201
Recruiting
Research Site
Madison, Wisconsin, 53792
Not yet recruiting
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Milwaukee, Wisconsin, 53226
Not yet recruiting
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Mineola, New York, 11501
Not yet recruiting
Research Site
Nashville, Tennessee, 37203
Recruiting
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New Brunswick, New Jersey, 08901
Not yet recruiting
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New Haven, Connecticut, 06510
Recruiting
Research Site
New Hyde Park, New York, 11042
Not yet recruiting
Research Site
New York, New York, 10016
Recruiting
Research Site
New York, New York, 10032
Recruiting
Research Site
New York, New York, 10065
Recruiting
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Newark, Delaware, 19713
Not yet recruiting
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Peoria, Illinois, 61615
Not yet recruiting
Research Site
Phoenix, Arizona, 85054
Recruiting
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Pittsburgh, Pennsylvania, 15232
Not yet recruiting
Research Site
Portland, Oregon, 97227
Withdrawn
Research Site
Richmond, Virginia, 23219
Not yet recruiting
Research Site
Rochester, Minnesota, 55905
Recruiting
Research Site
Saint Paul, Minnesota, 55102
Not yet recruiting
Research Site
Salt Lake City, Utah, 84112
Not yet recruiting
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San Diego, California, 92121
Not yet recruiting
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Santa Monica, California, 90404
Not yet recruiting
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Shenandoah, Texas, 77380
Not yet recruiting
Research Site
Springfield, Missouri, 65807
Recruiting
Research Site
Tacoma, Washington, 98405
Recruiting
Research Site
Tyler, Texas, 75702
Not yet recruiting
Research Site
Wilmington, North Carolina, 28401
Not yet recruiting
Research Site
Winston-Salem, North Carolina, 27103
Not yet recruiting
Research Site
Ypsilanti, Michigan, 48197
Not yet recruiting

Other trials in United States

China34 sites, 34 recruiting

Research Site
Beijing, 100044
Recruiting
Research Site
Beijing, 100142
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Research Site
Beijing, 100730
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Research Site
Changchun, 130021
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Changsha, 410013
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Research Site
Chengdu, 610078
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Research Site
Chongqing, 400030
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Research Site
Fuzhou, 350001
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Research Site
Guangzhou, 510000
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Research Site
Guangzhou, 510060
Recruiting
Research Site
Guangzhou, 510100
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Research Site
Hangzhou, 310003
Recruiting
Research Site
Hangzhou, 310022
Not yet recruiting
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Harbin, 150081
Recruiting
Research Site
Hefei, 230031
Recruiting
Research Site
Lanzhou, 730000
Recruiting
Research Site
Nanchang, 330006
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Research Site
Nanchang, 330029
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Research Site
Nanjing, 210029
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Research Site
Nanning, 530021
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Research Site
Shandong, 250117
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Research Site
Shanghai, 200065
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Research Site
Shanghai, 20032
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Research Site
Shenyang, 110001
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Research Site
Shenyang, 110004
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Shijiazhuang, 054001
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Suzhou, 215006
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Tianjin, 300020
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Wenzhou, 325000
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Wuhan, 430079
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Research Site
Xi'an, 710114
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Research Site
Xiamen, 361003
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Research Site
Zhengzhou, 450000
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Research Site
Zhengzhou, 450008
Recruiting

Other trials in China

Japan19 sites, 19 recruiting

Research Site
Bunkyō City, 113-8677
Recruiting
Research Site
Chiba, 260-8717
Recruiting
Research Site
Chuo-shi, 409-3898
Recruiting
Research Site
Fukuoka, 812-8582
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Research Site
Hirakata-shi, 573-1191
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Kobe, 650-0047
Recruiting
Research Site
Kōtoku, 135-8550
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Kumamoto, 860-8556
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Kurashiki-shi, 710-8602
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Kyoto, 602-8566
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Minatoku, 105-8470
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Okayama, 700-8558
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Osaka, 541-8567
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Sapporo, 003-0006
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Research Site
Sapporo, 060-8638
Recruiting
Research Site
Sunto-gun, 411-8777
Recruiting
Research Site
Toyoake-shi, 470-1192
Recruiting
Research Site
Yamagata, 990-9585
Recruiting
Research Site
Yokohama, 241-8515
Recruiting

Other trials in Japan

Germany17 sites, 17 recruiting

Research Site
Berlin, 10967
Not yet recruiting
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Berlin, 13353
Not yet recruiting
Research Site
Deggendorf, 94469
Not yet recruiting
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Düsseldorf, 40479
Not yet recruiting
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Göttingen, 37075
Not yet recruiting
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Hamburg, 20246
Not yet recruiting
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Heidelberg, 69120
Not yet recruiting
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Jena, 07747
Not yet recruiting
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Karlsruhe, 76133
Not yet recruiting
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Kiel, 24105
Not yet recruiting
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Lübeck, 23538
Not yet recruiting
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Magdeburg, 39120
Not yet recruiting
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Minden, 32429
Not yet recruiting
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München, 81377, DE
Not yet recruiting
Research Site
Münster, 48129
Not yet recruiting
Research Site
Regensburgs, 93049
Not yet recruiting
Research Site
Würzburg, 97080
Not yet recruiting

Other trials in Germany

Canada10 sites, 9 recruiting

Research Site
Barrie, Ontario, L4M 6M2
Withdrawn
Research Site
Chicoutimi, Quebec, G7H 5H6
Recruiting
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Halifax, Nova Scotia, B3H 2Y9
Recruiting
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Hamilton, Ontario, L8V 5C2
Recruiting
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Montreal, Quebec, H4J 1C5
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Oshawa, Ontario, L1G 2B9
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Québec, Quebec, G1J 1Z4
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Saint-Jérôme, Quebec, J7Z 2V4
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Toronto, Ontario, M5G 1X6
Recruiting
Research Site
Winnipeg, Manitoba, R3E 0V9
Recruiting

Other trials in Canada

Spain10 sites, 4 recruiting

Research Site
Barcelona, 08035
Not yet recruiting
Research Site
Barcelona, 8036
Withdrawn
Research Site
El Palmar, 30120
Withdrawn
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Girona, 17007
Not yet recruiting
Research Site
Las Palmas de Gran Canaria, 35020
Withdrawn
Research Site
Madrid, 28040
Withdrawn
Research Site
Madrid, 28041
Not yet recruiting
Research Site
Oviedo, 33011
Withdrawn
Research Site
Pamplona, 31008
Withdrawn
Research Site
Santander, 39008
Not yet recruiting

Other trials in Spain

Poland9 sites, 5 recruiting

Research Site
Gdansk, 80-214
Not yet recruiting
Research Site
Gliwice, 44-102
Withdrawn
Research Site
Katowice, 40-519
Not yet recruiting
Research Site
Krakow, 30-727
Not yet recruiting
Research Site
Lublin, 20-081
Withdrawn
Research Site
Lublin, 20-090
Suspended
Research Site
Warsaw, 02-781
Not yet recruiting
Research Site
Wroclaw, 50-019
Not yet recruiting
Research Site
Wroclaw, 53-439
Withdrawn

Other trials in Poland

South Korea9 sites, 9 recruiting

Research Site
Busan, 49201
Recruiting
Research Site
Busan, 49241
Recruiting
Research Site
Goyang-si, 10408
Recruiting
Research Site
Jeonnam, 519-763
Recruiting
Research Site
Seoul, 03080
Recruiting
Research Site
Seoul, 03722
Recruiting
Research Site
Seoul, 05505
Recruiting
Research Site
Seoul, 06351
Recruiting
Research Site
Seoul, 06591
Recruiting

Other trials in South Korea

Hungary8 sites, 5 recruiting

Research Site
Budapest, 1088
Withdrawn
Research Site
Budapest, 1122
Withdrawn
Research Site
Debrecen, 4032
Not yet recruiting
Research Site
Győr, 9024
Not yet recruiting
Research Site
Kaposvár, 7400
Not yet recruiting
Research Site
Nyíregyháza, 4400
Withdrawn
Research Site
Pécs, 7624
Not yet recruiting
Research Site
Szeged, 6725
Not yet recruiting

Other trials in Hungary

India7 sites, 7 recruiting

Research Site
Delhi, 110029
Not yet recruiting
Research Site
Delhi, 110085
Recruiting
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Gurugram, 122002
Not yet recruiting
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Kolkata, 700160
Recruiting
Research Site
Nashik, 422002
Recruiting
Research Site
Surat, 396007
Recruiting
Research Site
Thiruvananthapuram, 695011
Recruiting

Other trials in India

United Kingdom7 sites, 6 recruiting

Research Site
London, EC1M6BQ
Recruiting
Research Site
London, SE5 9RS
Recruiting
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Newcastle upon Tyne, NE7 7DN
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Norwich, NR4 7UY
Recruiting
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Nottingham, NG5 1PB
Recruiting
Research Site
Plymouth, PL6 8DH
Recruiting
Research Site
Southampton, SO16 6YD
Withdrawn

Other trials in United Kingdom

Australia6 sites, 6 recruiting

Research Site
Clayton, 3168
Not yet recruiting
Research Site
Darlinghurst, 2010
Recruiting
Research Site
Garran, 2605
Recruiting
Research Site
Heidelberg, 3084
Recruiting
Research Site
Macquarie University, 2109
Recruiting
Research Site
Nedlands, 6009
Recruiting

Other trials in Australia

France6 sites, 4 recruiting

Research Site
Bayonne, 64100
Not yet recruiting
Research Site
La Tronche, 38700
Withdrawn
Research Site
Lille, 59037
Not yet recruiting
Research Site
Montpellier, 34295
Not yet recruiting
Research Site
Saint-Cloud, 92210
Not yet recruiting
Research Site
Vandœuvre-lès-Nancy, 54511
Withdrawn

Other trials in France

Taiwan6 sites, 6 recruiting

Research Site
Changhua, 50006
Recruiting
Research Site
Kaohsiung City, 80756
Recruiting
Research Site
Kaohsiung City, 833
Recruiting
Research Site
Lukang Township, 505029
Recruiting
Research Site
Tainan, 704
Recruiting
Research Site
Taipei, 106
Recruiting

Other trials in Taiwan

Turkey (Türkiye)5 sites, 4 recruiting

Research Site
Ankara, 6200
Not yet recruiting
Research Site
Ankara, 6620
Not yet recruiting
Research Site
Istanbul, 34010
Not yet recruiting
Research Site
Istanbul, 34890
Not yet recruiting
Research Site
Izmir, 35340
Withdrawn

Other trials in Turkey (Türkiye)

Belgium4 sites, 4 recruiting

Research Site
Brussels, 1070
Not yet recruiting
Research Site
Brussels, 1090
Not yet recruiting
Research Site
Ghent, 9000
Not yet recruiting
Research Site
Mechelen, 2800
Not yet recruiting

Other trials in Belgium

Denmark4 sites, 2 recruiting

Research Site
Aalborg, 9100
Withdrawn
Research Site
Copenhagen, 2100
Recruiting
Research Site
Odense C, 5000
Recruiting
Research Site
Roskilde, 4000
Withdrawn

Other trials in Denmark

Thailand4 sites, 4 recruiting

Research Site
Bangkok, 10330
Recruiting
Research Site
Bangkok, 10700
Recruiting
Research Site
Chiang Mai, 50200
Recruiting
Research Site
Khon Kaen, 40002
Recruiting

Other trials in Thailand

Brazil3 sites, 3 recruiting

Research Site
Porto Alegre, 90035-003
Recruiting
Research Site
São Paulo, 04501-000
Recruiting
Research Site
São Paulo, 05652-900
Recruiting

Other trials in Brazil

Czechia3 sites, 3 recruiting

Research Site
Brno, 625 00
Not yet recruiting
Research Site
Hradec Králové, 500 05
Not yet recruiting
Research Site
Prague, 12808
Not yet recruiting

Other trials in Czechia

Finland3 sites

Research Site
Helsinki, 00029
Withdrawn
Research Site
Kuopio, 70029
Withdrawn
Research Site
Tampere, 33520
Withdrawn

Other trials in Finland

Italy3 sites, 3 recruiting

Research Site
Bologna, 40138
Not yet recruiting
Research Site
Milan, 20141
Not yet recruiting
Research Site
Reggio Emilia, 42100
Not yet recruiting

Other trials in Italy

Sweden2 sites

Research Site
Falun, 79182
Withdrawn
Research Site
Uppsala, 75185
Withdrawn

Other trials in Sweden

Hong Kong1 site, 1 recruiting

Research Site
Hong Kong, 999077
Recruiting

Other trials in Hong Kong

Puerto Rico1 site, 1 recruiting

Research Site
San Juan, 00918
Recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma (SOUNDTRACK-F1)

Read the detailed description

The study consists of 2 sequential parts.

Safety Run-in - this part will compare dose levels of Surovatamig (AZD0486) in combination with rituximab in order to establish the RP3D.
Phase III - The Phase III part will assess the superiority of Surovatamig (AZD0486) at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms
Arm A: treatment with Surovatamig plus rituximab Schedule A
Arm B: treatment with Surovatamig plus rituximab Schedule B
Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance or B-R + rituximab maintenance

Conditions: Untreated Follicular Lymphoma
Being tested: Surovatamig, R-CHOP, R-CVP, BR
Keywords: Follicular Lymphoma
Medical subject headings: Lymphoma, Follicular

What participants receive

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

SurovatamigDrug
Also called AZD0486
a fully human bispecific monoclonal IgG4 antibody
R-CHOPDrug
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
R-CVPDrug
Rituximab, Cyclophosphamide, Vincristine and Prednisone
BRDrug
Bendamustine, Rituximab

Study groups in NCT06549595
Study group	Role	What they receive
Rituximab, Surovatamig - A	Experimental	Surovatamig regimen A plus rituximab Receives: Drug: Surovatamig
Rituximab, Surovatamig - B	Experimental	Surovatamig regimen B plus rituximab Receives: Drug: Surovatamig
Chemoimmunotherapy	Active comparator	Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP, R-CVP, or B-R followed by rituximab maintenance) Receives: Drug: R-CHOP; Drug: R-CVP; Drug: BR

What is being measured

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

SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs
Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in physical examination and safety procedures.
Measured: Up to 10 years
SRI Primary: Determination of the recommended Phase III dose (RP3D)
The RP3D will be the dose of Surovatamig selected for the Phase 3 part based on safety data compiled during the safety run-in part
Measured: Up to 1 year
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy
PFS, based on Lugano 2014 Response Criteria, as assessed by BICR.
Measured: Up to 10 years
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy
ORR at EoI, based on Lugano 2014 Response Criteria, as assessed by BICR.
Measured: Up to 10 years

Secondary outcomes (9)

Safety Run in and Phase 3: ORR at EoI (Investigator assessed)
ORR defined as the proportion of participants achieving either a PR or CR at End of Induction based on Lugano 2014 Response Criteria
Measured: Up to 10 years
Safety Run In and Phase 3: CR Rate
CR rate is defined as the proportion of participants achieving a CR at any time as based on Lugano 2014 Response Criteria
Measured: Up to 10 years
Safety Run In and Phase 3: CR at EoI
Proportion of participants achieving CR at End of Induction based on Lugano 2014 Response Criteria
Measured: Up to 10 years
Safety Run In and Phase 3: DoR
DoR will be defined from the time of first response until progression based on Lugano 2014 criteria, or death due to any cause
Measured: up to 10 years
Safety Run In and Phase 3: PFS (Investigator assessed)
PFS (Investigator assessed) is defined as time from randomization until disease progression based on Lugano 2014 Response Criteria or death due to any cause
Measured: Up to 10 years
Safety Run In and Phase 3: OS
OS is defined as time until the date of death
Measured: Up to 10 years
Phase 3: CR rate at 30 months (CR30)
Proportion of participants in CR rate at 30 months (CR30) based on Lugano 2014 Response Criteria
Measured: Up to 30 months
Phase 3: Time to First Subsequent Therapy or Death (TFST)
TFST will be defined as the time from randomization until the start date of first subsequent anti-lymphoma therapy or death due to any cause
Measured: Up to 10 Years
Phase 3: Time from randomisation to second progression or death (PFS2)
PFS2 will be defined as the time from randomization until the earliest of the progression event, after first subsequent therapy, or death due to any cause
Measured: Up to 10 Years

Timeline

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

7 Aug 202426 Nov 2031

First posted12 Aug 2024
Study start7 Aug 2024
Primary completion26 Nov 2031 (estimated)
Study completion26 Nov 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Untreated Follicular LymphomaStudies 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: 1,018 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06549595
Sponsor's protocol ID: D7401C00001
Other IDs: 2023-510098-33-00, 2023
Status last verified: Oct 2026
First submitted: 29 Jul 2024
Last updated: 21 Oct 2026
Results posted: No
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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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 Untreated Follicular Lymphoma 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, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma (SOUNDTRACK-F1)
ClinicalTrials.gov ID: NCT06549595
Acronym / sponsor ID: D7401C00001
Conditions: Untreated Follicular Lymphoma
Keywords: Follicular Lymphoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,018 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 7 Aug 2024 (actual)
Primary completion: 26 Nov 2031 (estimated)
Study completion: 26 Nov 2031 (estimated)
First posted: 12 Aug 2024 (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.

Detailed description

The study consists of 2 sequential parts.

Safety Run-in - this part will compare dose levels of Surovatamig (AZD0486) in combination with rituximab in order to establish the RP3D.
Phase III - The Phase III part will assess the superiority of Surovatamig (AZD0486) at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms
Arm A: treatment with Surovatamig plus rituximab Schedule A
Arm B: treatment with Surovatamig plus rituximab Schedule B
Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance or B-R + rituximab maintenance

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Rituximab, Surovatamig - A	Experimental	Drug: SurovatamigSurovatamig regimen A plus rituximab
Rituximab, Surovatamig - B	Experimental	Drug: SurovatamigSurovatamig regimen B plus rituximab
Chemoimmunotherapy	Active comparator	Drug: R-CHOP, Drug: R-CVP, Drug: BRInvestigator's choice between 3 standard immunochemotherapy regimen (R-CHOP, R-CVP, or B-R followed by rituximab maintenance)

Who may qualify

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

Key inclusion criteria (9 listed)

Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
Histologically confirmed diagnosis of classic FL per WHO 2022 classification
ECOG performance status of 0 to 2
No prior systemic lymphoma-directed therapy
Need for systemic treatment meeting at least 1 GELF criteria

Key exclusion criteria (8 listed)

Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
Contra-indication to BR, RCVP, and R-CHOP
Participants with or history of CNS lymphoma
History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety
Presence of >5000 circulating lymphoma cells

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
SurovatamigAlso: AZD0486a fully human bispecific monoclonal IgG4 antibody	Drug	Rituximab, Surovatamig - A, Rituximab, Surovatamig - B
R-CHOPRituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone	Drug	Chemoimmunotherapy
R-CVPRituximab, Cyclophosphamide, Vincristine and Prednisone	Drug	Chemoimmunotherapy
BRBendamustine, Rituximab	Drug	Chemoimmunotherapy

Primary outcome

SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs
Time frame: Up to 10 years
Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in physical examination and safety procedures.
SRI Primary: Determination of the recommended Phase III dose (RP3D)
Time frame: Up to 1 year
The RP3D will be the dose of Surovatamig selected for the Phase 3 part based on safety data compiled during the safety run-in part
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy
Time frame: Up to 10 years
PFS, based on Lugano 2014 Response Criteria, as assessed by BICR.
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy
Time frame: Up to 10 years
ORR at EoI, based on Lugano 2014 Response Criteria, as assessed by BICR.

9 secondary outcomes

Safety Run in and Phase 3: ORR at EoI (Investigator assessed)
Time frame: Up to 10 years
Safety Run In and Phase 3: CR Rate
Time frame: Up to 10 years
Safety Run In and Phase 3: CR at EoI
Time frame: Up to 10 years
Safety Run In and Phase 3: DoR
Time frame: up to 10 years
Safety Run In and Phase 3: PFS (Investigator assessed)
Time frame: Up to 10 years
Safety Run In and Phase 3: OS
Time frame: Up to 10 years
Phase 3: CR rate at 30 months (CR30)
Time frame: Up to 30 months
Phase 3: Time to First Subsequent Therapy or Death (TFST)
Time frame: Up to 10 Years
Phase 3: Time from randomisation to second progression or death (PFS2)
Time frame: Up to 10 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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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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

Chan Cheah, MBBS FRACP FRCPA DMSc principal investigator

Sir Charles Gairdner Hospital (SCGH)

244 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Surovatamig, R-CHOP and R-CVP in people with Untreated Follicular Lymphoma, run by AstraZeneca at 244 sites in 25 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 9 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 244 sites in United States, China, Japan, Germany, Canada and 20 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?

SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs (time frame: Up to 10 years). The study lists 4 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 NCT06549595.

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.