Recruiting
Phase 3

AZD0486 & Rituximab

Sponsor:

AstraZeneca

Code:

NCT06549595

Conditions

Untreated Follicular Lymphoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Surovatamig

R-CHOP

R-CVP

BR

Study Details

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

Study ID

NCT06549595

Start date

Aug 7, 2024

Status verified date

Aug, 2026

Completion date

Nov 26, 2031

Anticipated

Primary completion date

Nov 26, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

1. 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
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 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
5. Presence of >5000 circulating lymphoma cells
6. 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
7. Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)

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

Study Design

Enrollment

1018 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rituximab, Surovatamig - A

Surovatamig regimen A plus rituximab

experimental: Rituximab, Surovatamig - B

Surovatamig regimen B plus rituximab

active comparator: Chemoimmunotherapy

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

Interventions

Surovatamig

a fully human bispecific monoclonal IgG4 antibody

R-CHOP

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

R-CVP

Rituximab, Cyclophosphamide, Vincristine and Prednisone

BR

Bendamustine, Rituximab

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 ]
  • SRI Primary: Determination of the recommended Phase III dose (RP3D) [ Time Frame: Up to 1 year ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Anchorage, Alaska, United States, 99508

Research Site

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Research Site

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Research Site

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Research Site

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 1X6

Research Site

Recruiting

Chicoutimi, Quebec, Canada, G7H 5H6

Research Site

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Research Site

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Research Site

Recruiting

Saint-Jérôme, Quebec, Canada, J7Z 2V4

More Information

Sponsor

AstraZeneca

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Follicular Lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-19.