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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510098-33-01

Enrollment

Registered

2026-07-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma

Brief summary

1.SRI primary: Safety evaluation of Surovatamig in combination with Rituximab, 2.SRI Primary: Determination of the recommended Phase III dose (RP3D), 3.Phase 3 Primary: To demonstrate the superiority of clinical efficacy of Surovatamig+R compared to SOC chemoimmunotherapy in participants with untreated FL

Detailed description

Safety Run in and Phase 3: ORR, Safety Run In and Phase 3: CR Rate, Safety Run In and Phase 3: CR at EoI, Safety Run In and Phase 3: DoR, Safety Run In and Phase 3: PFS, Safety Run In and Phase 3: OS, Phase 3: CR rate at 30 months, Phase 3: TFST, Phase 3: PFS2

Interventions

DRUGRITUXIMAB

DRUGVINCRISTINE

DRUGDOXORUBICIN

DRUGPREDNISONE

DRUGAZD0486

DRUGBENDAMUSTINE

DRUGCYCLOPHOSPHAMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1.SRI primary: Safety evaluation of Surovatamig in combination with Rituximab, 2.SRI Primary: Determination of the recommended Phase III dose (RP3D), 3.Phase 3 Primary: To demonstrate the superiority of clinical efficacy of Surovatamig+R compared to SOC chemoimmunotherapy in participants with untreated FL	—

Secondary

Measure	Time frame
Safety Run in and Phase 3: ORR, Safety Run In and Phase 3: CR Rate, Safety Run In and Phase 3: CR at EoI, Safety Run In and Phase 3: DoR, Safety Run In and Phase 3: PFS, Safety Run In and Phase 3: OS, Phase 3: CR rate at 30 months, Phase 3: TFST, Phase 3: PFS2	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 30, 2026