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This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the AZD0486 plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL. (SOUNDTRACK-F1)

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

Hibi Kazushige

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

RD-clinical-information-Japan@astrazeneca.com

Hibi Kazushige

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

+81-6-4802-3533

RD-clinical-information-Japan@astrazenec

Recruiting

Dec. 05, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

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.

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

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

Both

Untreated Follicular Lymphoma

Experimental: Rituximab, AZD0486 - A
AZD0486 regimen A plus rituximab
- Drug: AZD0486 (a fully human bispecific monoclonal IgG4 antibody)

Experimental: Rituximab, AZD0486 - B
AZD0486 regimen B plus rituximab
- Drug: AZD0486 (a fully human bispecific monoclonal IgG4 antibody)

Active Comparator: Chemoimmunotherapy

Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP, R-CVP, or B-R followed by rituximab maintenance)
- Drug: R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone)
- Drug: R-CVP (Rituximab, Cyclophosphamide, Vincristine and Prednisolone)
- Drug: B-R (Bendamustine and Rituximab)

Safety Run-in Part:
- To assess the safety and tolerability of AZD0486 plus rituximab in participants with previously untreated FL
- To determine the recommended Phase III dose (RP3D)
[Description] Incidence, nature, and severity of AEs and SAEs based on NCI CTCAE v5.0/ASTCT and changes in laboratory data and vital signs compared with baseline. Incidence and nature of study intervention discontinuations, dose reductions, and dose delays due to AEs.
Phase 3 Part:
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.
[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
ORR at EoI, based on Lugano 2014 Response Criteria, as assessed by BICR.
[Time Frame: Up to 10 years]

Nov. 06, 2024

No

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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