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

Last updated: February 13, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Follicular Lymphoma

Lymphoma

Treatment

R-CVP

Surovatamig

R-CHOP

Clinical Study ID

NCT06549595
D7401C00001
2023-510098-33-00
  • Ages 18-130
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must be at least 18 years of age, inclusive, at the time of signing theICF.

  2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification

  3. ECOG performance status of 0 to 2

  4. No prior systemic lymphoma-directed therapy

  5. Need for systemic treatment meeting at least 1 GELF criteria

  6. FDG-avid and measurable disease

  7. Stage II to IV and FLIPI 2-5 [Phase III only]

  8. Adequate liver, hematological, renal and cardiac function.

The above is a summary, other inclusion criteria details may apply

Exclusion

Exclusion Criteria:

  1. Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicularlymphoma Grade 3B (WHO 2016 classification) or suspicion for histologictransformation to high-grade/aggressive lymphoma

  2. Contra-indication to BR, RCVP, and R-CHOP

  3. Participants with or history of CNS lymphoma

  4. History of a clinically relevant CNS medical condition or pathology that requiredtreatment in the preceding year, is currently symptomatic or that which the treatinginvestigator considers to have the potential to interfere with the evaluation ofsafety

  5. Presence of >5000 circulating lymphoma cells

  6. Active or uncontrolled infection (including EBV) requiring systemic therapy andwhich places participant at unacceptable risk if he/she were to participate in thestudy. If a participant has a history of COVID-19 within 1 month of C1D1 orcontracts COVID while on study treatment, participant must have 2 consecutivenegative tests (PCR testing is preferable) performed at least 48 hours apart priorto resuming dosing. All symptoms related to COVID-19 infection should have fullyresolved before initiating or resuming treatment

  7. Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)

The above is a summary, other exclusion criteria details may apply

Study Design

Total Participants: 1015
Treatment Group(s): 5
Primary Treatment: R-CVP
Phase: 3
Study Start date:
August 07, 2024
Estimated Completion Date:
November 26, 2031

Study Description

The study consists of 2 sequential parts.

  1. Safety Run-in - this part will compare dose levels of Surovatamig (AZD0486) in combination with rituximab in order to establish the RP3D.

  2. 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

    1. Arm A: treatment with Surovatamig plus rituximab Schedule A

    2. Arm B: treatment with Surovatamig plus rituximab Schedule B

    3. 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

Connect with a study center

  • Research Site

    Garran 9973428, 2605
    Australia

    Active - Recruiting

  • Research Site

    Heidelberg 2163654, 3084
    Australia

    Active - Recruiting

  • Research Site

    Macquarie University, 2109
    Australia

    Active - Recruiting

  • Research Site

    Nedlands, 6009
    Australia

    Site Not Available

  • Research Site

    Nedlands 2064874, 6009
    Australia

    Active - Recruiting

  • Research Site

    Brussel, 1090
    Belgium

    Site Not Available

  • Research Site

    Brussels, 1070
    Belgium

    Site Not Available

  • Research Site

    Brussels 2800866, 1070
    Belgium

    Site Not Available

  • Research Site

    Gent, 9000
    Belgium

    Site Not Available

  • Research Site

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • Research Site

    Mechelen, 2800
    Belgium

    Site Not Available

  • Research Site

    Mechelen 2791537, 2800
    Belgium

    Site Not Available

  • Research Site

    Porto Alegre, 90035-003
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre 3452925, 90035-003
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo, 04501-000
    Brazil

    Site Not Available

  • Research Site

    São Paulo 3448439, 04501-000
    Brazil

    Active - Recruiting

  • Research Site

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • Research Site

    Winnipeg 6183235, Manitoba 6065171 R3E 0V9
    Canada

    Site Not Available

  • Research Site

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Research Site

    Halifax 6324729, Nova Scotia 6091530 B3H 2Y9
    Canada

    Site Not Available

  • Research Site

    Barrie, Ontario L4M 6M2
    Canada

    Site Not Available

  • Research Site

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • Research Site

    Oshawa, Ontario L1G 2B9
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario M5G 1X6
    Canada

    Site Not Available

  • Research Site

    Barrie 5894171, Ontario 6093943 L4M 6M2
    Canada

    Site Not Available

  • Research Site

    Hamilton 5969782, Ontario 6093943 L8V 5C2
    Canada

    Active - Recruiting

  • Research Site

    Oshawa 6094578, Ontario 6093943 L1G 2B9
    Canada

    Active - Recruiting

  • Research Site

    Toronto 6167865, Ontario 6093943 M5G 1X6
    Canada

    Site Not Available

  • Research Site

    Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H4J 1C5
    Canada

    Site Not Available

  • Research Site

    Montréal, Quebec H4J 1C5
    Canada

    Site Not Available

  • Research Site

    Saint-Jérôme, Quebec J7Z 2V4
    Canada

    Site Not Available

  • Research Site

    Chicoutimi 5921225, Quebec 6115047 G7H 5H6
    Canada

    Active - Recruiting

  • Research Site

    Montreal 6077243, Quebec 6115047 H4J 1C5
    Canada

    Active - Recruiting

  • Research Site

    Québec 6325494, Quebec 6115047 G1J 1Z4
    Canada

    Active - Recruiting

  • Research Site

    Saint-Jérôme 6138501, Quebec 6115047 J7Z 2V4
    Canada

    Active - Recruiting

  • Research Site

    Quebec, G1V 4G2
    Canada

    Site Not Available

  • Research Site

    Beijing, 100044
    China

    Site Not Available

  • Research Site

    Beijing 1816670, 100730
    China

    Site Not Available

  • Research Site

    Changchun, 130021
    China

    Site Not Available

  • Research Site

    Changchun 2038180, 130021
    China

    Site Not Available

  • Research Site

    Changsha, 410013
    China

    Site Not Available

  • Research Site

    Changsha 1815577, 410013
    China

    Site Not Available

  • Research Site

    Chengdu, 610078
    China

    Site Not Available

  • Research Site

    Chengdu 1815286, 610078
    China

    Site Not Available

  • Research Site

    Chongqing, 400030
    China

    Site Not Available

  • Research Site

    Chongqing 1814906, 400030
    China

    Site Not Available

  • Research Site

    Fuzhou, 350001
    China

    Site Not Available

  • Research Site

    Fuzhou 1810821, 350001
    China

    Site Not Available

  • Research Site

    Guangzhou, 510060
    China

    Site Not Available

  • Research Site

    Guangzhou 1809858, 510060
    China

    Site Not Available

  • Research Site

    Hangzhou 1808926, 310022
    China

    Site Not Available

  • Research Site

    Harbin 2037013, 150081
    China

    Site Not Available

  • Research Site

    Hefei, 230031
    China

    Site Not Available

  • Research Site

    Hefei 1808722, 230031
    China

    Site Not Available

  • Research Site

    Hohhot, 610078
    China

    Site Not Available

  • Research Site

    Lanzhou, 730000
    China

    Site Not Available

  • Research Site

    Lanzhou 1804430, 730000
    China

    Site Not Available

  • Research Site

    Nanchang, 330029
    China

    Site Not Available

  • Research Site

    Nanchang 1800163, 330029
    China

    Site Not Available

  • Research Site

    Nanjing, 210029
    China

    Site Not Available

  • Research Site

    Nanjing 1799962, 210029
    China

    Site Not Available

  • Research Site

    Nanning, 530021
    China

    Site Not Available

  • Research Site

    Nanning 1799869, 530021
    China

    Site Not Available

  • Research Site

    Shandong, 250117
    China

    Site Not Available

  • Research Site

    Shandong 7401388, 250117
    China

    Site Not Available

  • Research Site

    Shandong 9617160, 250117
    China

    Site Not Available

  • Research Site

    Shanghai, 20032
    China

    Site Not Available

  • Research Site

    Shanghai 1796236, 20032
    China

    Site Not Available

  • Research Site

    Shenyang, 110001
    China

    Site Not Available

  • Research Site

    Shenyang 2034937, 110004
    China

    Site Not Available

  • Research Site

    Shijiazhuang, 054001
    China

    Site Not Available

  • Research Site

    Shijiazhuang 1795270, 054001
    China

    Site Not Available

  • Research Site

    Suzhou, 215006
    China

    Site Not Available

  • Research Site

    Suzhou 1886760, 215006
    China

    Site Not Available

  • Research Site

    Tianjin, 300020
    China

    Site Not Available

  • Research Site

    Tianjin 1792947, 300020
    China

    Active - Recruiting

  • Research Site

    Wenzhou 1791388, 325000
    China

    Site Not Available

  • Research Site

    Wuhan, 430079
    China

    Site Not Available

  • Research Site

    Wuhan 1791247, 430079
    China

    Site Not Available

  • Research Site

    Xi'an, 710061
    China

    Site Not Available

  • Research Site

    Xi'an 1790630, 710061
    China

    Site Not Available

  • Research Site

    Xiamen, 361003
    China

    Site Not Available

  • Research Site

    Xiamen 1790645, 361003
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450008
    China

    Site Not Available

  • Research Site

    Zhengzhou 1784658, 450008
    China

    Site Not Available

  • Research Site

    Zhengzhou City, 450000
    China

    Site Not Available

  • Research Site

    Helsinki, 00029
    Finland

    Site Not Available

  • Research Site

    Helsinki 658225, 00029
    Finland

    Site Not Available

  • Research Site

    Kuopio, 70029
    Finland

    Site Not Available

  • Research Site

    Kuopio 650224, 70029
    Finland

    Site Not Available

  • Research Site

    Tampere, 33520
    Finland

    Site Not Available

  • Research Site

    Tampere 634963, 33520
    Finland

    Site Not Available

  • Research Site

    Hong Kong, 999077
    Hong Kong

    Site Not Available

  • Research Site

    Hong Kong 1819729, 999077
    Hong Kong

    Active - Recruiting

  • Research Site

    Shatin, 00000
    Hong Kong

    Site Not Available

  • Research Site

    Shatin 1818920, 00000
    Hong Kong

    Site Not Available

  • Research Site

    Budapest, 1122
    Hungary

    Site Not Available

  • Research Site

    Budapest 3054643, 1122
    Hungary

    Site Not Available

  • Research Site

    Delhi 1273294, 110029
    India

    Site Not Available

  • Research Site

    Gurugram 1270642, 122002
    India

    Site Not Available

  • Research Site

    Kolkata 1275004, 700160
    India

    Site Not Available

  • Research Site

    Nashik 1261731, 422002
    India

    Site Not Available

  • Research Site

    Surat 1255364, 396007
    India

    Site Not Available

  • Research Site

    Thiruvananthapuram 1254163, 695011
    India

    Site Not Available

  • Research Site

    Bunkyo-ku, 113-8677
    Japan

    Site Not Available

  • Research Site

    Bunkyō City 11790632, 113-8677
    Japan

    Active - Recruiting

  • Research Site

    Chiba 2113015, 260-8717
    Japan

    Active - Recruiting

  • Research Site

    Chuo-shi, 409-3898
    Japan

    Active - Recruiting

  • Research Site

    Fukuoka 1863967, 812-8582
    Japan

    Active - Recruiting

  • Research Site

    Fukuoka-shi, 812-8582
    Japan

    Site Not Available

  • Research Site

    Hirakata-shi, 573-1191
    Japan

    Site Not Available

  • Research Site

    Kobe 1859171, 650-0047
    Japan

    Active - Recruiting

  • Research Site

    Kobe-shi, 650-0047
    Japan

    Site Not Available

  • Research Site

    Koto-ku, 135-8550
    Japan

    Site Not Available

  • Research Site

    Kumamoto 1858421, 860-8556
    Japan

    Active - Recruiting

  • Research Site

    Kumamoto-shi, 860-8556
    Japan

    Site Not Available

  • Research Site

    Kurashiki-shi, 710-8602
    Japan

    Site Not Available

  • Research Site

    Kyoto 1857910, 602-8566
    Japan

    Active - Recruiting

  • Research Site

    Kyoto-shi, 602-8566
    Japan

    Site Not Available

  • Research Site

    Kōtoku 2128852, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Minato-ku, 105-8470
    Japan

    Site Not Available

  • Research Site

    Minatoku 11191118, 105-8470
    Japan

    Active - Recruiting

  • Research Site

    Okayama 1854383, 700-8558
    Japan

    Active - Recruiting

  • Research Site

    Okayama-shi, 700-8558
    Japan

    Site Not Available

  • Research Site

    Osaka 1853909, 541-8567
    Japan

    Active - Recruiting

  • Research Site

    Sapporo 2128295, 003-0006
    Japan

    Active - Recruiting

  • Research Site

    Sapporo-shi, 060-8638
    Japan

    Site Not Available

  • Research Site

    Sunto-gun, 411-8777
    Japan

    Active - Recruiting

  • Research Site

    Toyoake-shi, 470-1192
    Japan

    Site Not Available

  • Research Site

    Yamagata 2110556, 990-9585
    Japan

    Active - Recruiting

  • Research Site

    Yokohama 1848354, 241-8515
    Japan

    Active - Recruiting

  • Research Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Research Site

    Gliwice, 44-102
    Poland

    Site Not Available

  • Research Site

    Gliwice 3099230, 44-102
    Poland

    Site Not Available

  • Research Site

    Busan 1838524, 49201
    South Korea

    Active - Recruiting

  • Research Site

    Goyang-si 1842485, 10408
    South Korea

    Active - Recruiting

  • Research Site

    Jeonnam, 519-763
    South Korea

    Active - Recruiting

  • Research Site

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Research Site

    Barcelona, 8036
    Spain

    Site Not Available

  • Research Site

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Research Site

    El Palmar, 30120
    Spain

    Site Not Available

  • Research Site

    El Palmar 2518293, 30120
    Spain

    Site Not Available

  • Research Site

    Girona, 17007
    Spain

    Site Not Available

  • Research Site

    Girona 3121456, 17007
    Spain

    Site Not Available

  • Research Site

    Las Palmas de Gran Canaria, 35020
    Spain

    Site Not Available

  • Research Site

    Las Palmas de Gran Canaria 2515270, 35020
    Spain

    Site Not Available

  • Research Site

    Madrid, 28041
    Spain

    Site Not Available

  • Research Site

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Research Site

    Oviedo, 33011
    Spain

    Site Not Available

  • Research Site

    Oviedo 3114711, 33011
    Spain

    Site Not Available

  • Research Site

    Pamplona, 31008
    Spain

    Site Not Available

  • Research Site

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • Research Site

    Santander, 39008
    Spain

    Site Not Available

  • Research Site

    Santander 3109718, 39008
    Spain

    Site Not Available

  • Research Site

    Falun, 79182
    Sweden

    Site Not Available

  • Research Site

    Falun 2715459, 79182
    Sweden

    Site Not Available

  • Research Site

    Uppsala, 75185
    Sweden

    Site Not Available

  • Research Site

    Uppsala 2666199, 75185
    Sweden

    Site Not Available

  • Research Site

    Changhua, 50006
    Taiwan

    Site Not Available

  • Research Site

    Changhua 1993459, 50006
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City, 80756
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City 1673820, 833
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung city, 833
    Taiwan

    Active - Recruiting

  • Research Site

    Lukang Township, 505029
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan 1668355, 704
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan City, 704
    Taiwan

    Site Not Available

  • Research Site

    Tainan City 1668355, 704
    Taiwan

    Site Not Available

  • Research Site

    Taipei 1668341, 106
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei City, 106
    Taiwan

    Site Not Available

  • Research Site

    Bangkok 1609350, 10330
    Thailand

    Active - Recruiting

  • Research Site

    Chiang Mai 1153671, 50200
    Thailand

    Active - Recruiting

  • Research Site

    Khon Kaen 1609776, 40002
    Thailand

    Active - Recruiting

  • Research Site

    Ankara, 06620
    Turkey

    Site Not Available

  • Research Site

    Ankara 323786, 06620
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Research Site

    London 2643743, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Research Site

    Newcastle upon Tyne 2641673, NE7 7DN
    United Kingdom

    Site Not Available

  • Research Site

    Newcastle-Upon-Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Research Site

    Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • Research Site

    Norwich 2641181, NR4 7UY
    United Kingdom

    Active - Recruiting

  • Research Site

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Research Site

    Nottingham 2641170, NG5 1PB
    United Kingdom

    Site Not Available

  • Research Site

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Research Site

    Plymouth 2640194, PL6 8DH
    United Kingdom

    Active - Recruiting

  • Research Site

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Research Site

    Southampton 2637487, SO16 6YD
    United Kingdom

    Site Not Available

  • Research Site

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Research Site

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

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