NCT06549595

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

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: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,018 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Untreated Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Surovatamig	a fully human bispecific monoclonal IgG4 antibody
DRUG	R-CHOP	Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
DRUG	R-CVP	Rituximab, Cyclophosphamide, Vincristine and Prednisone
DRUG	BR	Bendamustine, Rituximab

Timeline

• Start date: 2024-08-07
• Primary completion: 2031-11-26
• Completion: 2031-11-26
• First posted: 2024-08-12
• Last updated: 2026-04-17

Locations

159 sites across 18 countries: United States, Australia, Belgium, Brazil, Canada, China, Finland, Hong Kong, Hungary, India, Japan, Poland, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study