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

NCT06549595 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: D7401C000012023-510098-33-00
• Study Type: interventional
• Target: 1,018
• Locations: 18 countries
• Sites: 159

Brief 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.

Conditions

Untreated Follicular Lymphoma

Keywords

Follicular Lymphoma

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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.

  Up to 10 years

Secondary Outcomes (9)

• Safety Run in and Phase 3: ORR at EoI (Investigator assessed)

  Up to 10 years

• Safety Run In and Phase 3: CR Rate

  Up to 10 years

• Safety Run In and Phase 3: CR at EoI

  Up to 10 years

• Safety Run In and Phase 3: DoR

  up to 10 years

• Safety Run In and Phase 3: PFS (Investigator assessed)

  Up to 10 years

Study Arms (3)

Rituximab, Surovatamig - A

EXPERIMENTAL

Surovatamig regimen A plus rituximab

Drug: Surovatamig

Rituximab, Surovatamig - B

EXPERIMENTAL

Surovatamig regimen B plus rituximab

Drug: Surovatamig

Chemoimmunotherapy

ACTIVE COMPARATOR

Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP, R-CVP, or B-R followed by rituximab maintenance)

Drug: R-CHOP; Drug: R-CVP; Drug: BR

Interventions

Surovatamig DRUG

a fully human bispecific monoclonal IgG4 antibody

Also known as: AZD0486

Rituximab, Surovatamig - A; Rituximab, Surovatamig - B

R-CHOP DRUG

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

Chemoimmunotherapy

R-CVP DRUG

Rituximab, Cyclophosphamide, Vincristine and Prednisone

Chemoimmunotherapy

BR DRUG

Bendamustine, Rituximab

Chemoimmunotherapy

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Stage II to IV and FLIPI 2-5 \[Phase III only\]
• Adequate liver, hematological, renal and cardiac function.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (159)

Research Site

Anchorage, Alaska, 99508, United States

NOT YET RECRUITING

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Phoenix, Arizona, 85054, United States

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Clovis, California, 93611, United States

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Los Alamitos, California, 90720, United States

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San Diego, California, 92121, United States

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Santa Monica, California, 90404, United States

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Aurora, Colorado, 80045, United States

WITHDRAWN

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New Haven, Connecticut, 06510, United States

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Jacksonville, Florida, 32224, United States

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Atlanta, Georgia, 30322, United States

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Macon, Georgia, 31201, United States

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Fort Wayne, Indiana, 46804, United States

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Des Moines, Iowa, 50309, United States

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Iowa City, Iowa, 52242, United States

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Louisville, Kentucky, 40207, United States

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Baltimore, Maryland, 21201, United States

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Bethesda, Maryland, 20817, United States

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Boston, Massachusetts, 02215, United States

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Ann Arbor, Michigan, 48109, United States

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Detroit, Michigan, 48201, United States

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Ypsilanti, Michigan, 48197, United States

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Springfield, Missouri, 65807, United States

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New Brunswick, New Jersey, 08901, United States

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New Hyde Park, New York, 11042, United States

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New York, New York, 10016, United States

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New York, New York, 10032, United States

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New York, New York, 10065, United States

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Columbus, Ohio, 43210, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Nashville, Tennessee, 37203, United States

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Tacoma, Washington, 98405, United States

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Madison, Wisconsin, 53792, United States

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Darlinghurst, 2010, Australia

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Garran, 2605, Australia

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Heidelberg, 3084, Australia

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Macquarie University, 2109, Australia

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Nedlands, 6009, Australia

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Ghent, 9000, Belgium

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Mechelen, 2800, Belgium

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Porto Alegre, 90035-003, Brazil

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São Paulo, 04501-000, Brazil

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São Paulo, 05652-900, Brazil

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Winnipeg, Manitoba, R3E 0V9, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Barrie, Ontario, L4M 6M2, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Toronto, Ontario, M5G 1X6, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Saint-Jérôme, Quebec, J7Z 2V4, Canada

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Beijing, 100044, China

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Beijing, 100142, China

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Beijing, 100730, China

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Changchun, 130021, China

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Changsha, 410013, China

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Chengdu, 610078, China

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Chongqing, 400030, China

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Fuzhou, 350001, China

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Guangzhou, 510000, China

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Guangzhou, 510060, China

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Guangzhou, 510100, China

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Hangzhou, 310003, China

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Hangzhou, 310022, China

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Harbin, 150081, China

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Hefei, 230031, China

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Lanzhou, 730000, China

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Nanchang, 330006, China

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Nanchang, 330029, China

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Nanjing, 210029, China

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Nanning, 530021, China

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Shandong, 250117, China

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Shanghai, 200065, China

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Shanghai, 20032, China

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Shenyang, 110001, China

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Shenyang, 110004, China

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Shijiazhuang, 054001, China

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Suzhou, 215006, China

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Tianjin, 300020, China

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Wenzhou, 325000, China

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Wuhan, 430079, China

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Xi'an, 710061, China

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Xiamen, 361003, China

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Zhengzhou, 450000, China

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Zhengzhou, 450008, China

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Helsinki, 00029, Finland

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Kuopio, 70029, Finland

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Tampere, 33520, Finland

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Hong Kong, 999077, Hong Kong

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Shatin, 00000, Hong Kong

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Budapest, 1122, Hungary

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Delhi, 110029, India

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Delhi, 110085, India

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Gurugram, 122002, India

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Kolkata, 700160, India

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Nashik, 422002, India

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Surat, 396007, India

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Thiruvananthapuram, 695011, India

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Bunkyō City, 113-8677, Japan

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Chiba, 260-8717, Japan

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Chuo-shi, 409-3898, Japan

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Fukuoka, 812-8582, Japan

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Hirakata-shi, 573-1191, Japan

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Kobe, 650-0047, Japan

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Kōtoku, 135-8550, Japan

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Kumamoto, 860-8556, Japan

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Kurashiki-shi, 710-8602, Japan

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Kyoto, 602-8566, Japan

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Minatoku, 105-8470, Japan

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Okayama, 700-8558, Japan

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Osaka, 541-8567, Japan

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Sapporo, 003-0006, Japan

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Sapporo, 060-8638, Japan

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Sunto-gun, 411-8777, Japan

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Toyoake-shi, 470-1192, Japan

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Yamagata, 990-9585, Japan

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Yokohama, 241-8515, Japan

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Gliwice, 44-102, Poland

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Busan, 49201, South Korea

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Busan, 49241, South Korea

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Goyang-si, 10408, South Korea

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Jeonnam, 519-763, South Korea

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Seoul, 03080, South Korea

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Seoul, 03722, South Korea

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Seoul, 05505, South Korea

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Seoul, 06351, South Korea

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Seoul, 06591, South Korea

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Barcelona, 08035, Spain

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Barcelona, 8036, Spain

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El Palmar, 30120, Spain

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Girona, 17007, Spain

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Las Palmas de Gran Canaria, 35020, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Oviedo, 33011, Spain

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Pamplona, 31008, Spain

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Santander, 39008, Spain

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Falun, 79182, Sweden

WITHDRAWN

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Uppsala, 75185, Sweden

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Changhua, 50006, Taiwan

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Kaohsiung City, 80756, Taiwan

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Kaohsiung City, 833, Taiwan

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Lukang Township, 505029, Taiwan

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Tainan, 704, Taiwan

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Taipei, 106, Taiwan

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Bangkok, 10330, Thailand

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

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Khon Kaen, 40002, Thailand

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London, EC1M6BQ, United Kingdom

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London, SE5 9RS, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Norwich, NR4 7UY, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Southampton, SO16 6YD, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

R-CHOP protocol

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Chan Cheah, MBBS FRACP FRCPA DMSc

  Sir Charles Gairdner Hospital (SCGH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 12, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): November 26, 2031
• Study Completion (Estimated): November 26, 2031
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Locations

AU (5); CA (10); FI (3); IN (7); PL (1); US (32); SE (2); TH (4); TW (6); KR (9); HU (1); BE (4); BR (3); ES (10); HK (2); GB (7); CN (34); JP (19)