AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL (SOUNDTRACK-D2)

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Large B-cell Lymphoma

Treatments: Drug: R-mini-CHOP; Drug: AZD0486

Study type: Interventional

Funder types: Industry

Identifiers

NCT07215585

D7402C00001

2025-522029-37-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to measure the efficacy and safety of R-mini-CHOP × 2 followed by AZD0486 compared with R-mini-CHOP × 6 in elderly or unfit participants newly diagnosed with LBCL.

Enrollment: 420 estimated patients

Sex: All

Ages: 65 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment;
• Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma;
• FDG-avid and measurable disease as per Lugano and Ann Arbor staging;
• Stage I bulky (7.5 cm and greater) to Stage IV;
• ECOG performance status 0 to 2;
• Adequate bone marrow, liver, renal and cardiac function.

The above is a summary, other inclusion criteria details may apply.

• As judged by the investigator, any evidence of diseases which make it undesirable for the participant to participate in the study, or that would jeopardise compliance with the protocol
• Diagnosis of post-transplant lymphoproliferative disease, plasmablastic lymphoma, Richter's transformation, prior history of or concurrent indolent lymphoma (including de novo transformed or composite lymphoma).
• History of CNS involvement by their B-NHL or history of clinically relevant CNS medical condition
• Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
• Active or uncontrolled infection
• Major cardiac abnormalities
• Prior anti-lymphoma therapy except for corticosteroids for symptom control
• Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition, with some exceptions

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 3 patient groups

Phase III Arm A: R-mini-CHOP and AZD0486

Experimental group

Description:

2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP3D.

Treatment:

Drug: AZD0486

Drug: R-mini-CHOP

Phase III Arm B: R-mini-CHOP

Active Comparator group

Description:

6 cycles of R-mini-CHOP per SoC regimen.

Treatment:

Drug: R-mini-CHOP

Safety Run in: R-mini-CHOP and AZD0486

Experimental group

Description:

2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP2D.

Treatment:

Drug: AZD0486

Drug: R-mini-CHOP