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)

Condition studied

Follicular Lymphoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

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

Endpoint detail

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