Study identifier:D7402C00001
ClinicalTrials.gov identifier:NCT07215585
EudraCT identifier:N/A
CTIS identifier:2025-522029-37-00
A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 followed by AZD0486 versus R-mini-CHOP x6 in Elderly or Unfit Participants with Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)
Large B-cell lymphoma
Phase 3
No
AZD0486, R-mini-CHOP
All
420
Interventional
65 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Nov 2025 by AstraZeneca
AstraZeneca
-
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Phase III Arm A: R-mini-CHOP and AZD0486 2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP3D. | Drug: AZD0486 Bispecific monoclonal IgG4 antibody Other Name: TNB-486 Drug: R-mini-CHOP Intravenous administration: Rituximab 375 mg/m2, Cyclophosphamide 400 mg/m2, Doxorubicin 25 mg/m2, Vincristine 1 mg, and Oral administration: Prednisone 40 mg/m2 |
| Active Comparator: Phase III Arm B: R-mini-CHOP 6 cycles of R-mini-CHOP per SoC regimen. | Drug: R-mini-CHOP Intravenous administration: Rituximab 375 mg/m2, Cyclophosphamide 400 mg/m2, Doxorubicin 25 mg/m2, Vincristine 1 mg, and Oral administration: Prednisone 40 mg/m2 |
| Experimental: Safety Run in: R-mini-CHOP and AZD0486 2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP2D. | Drug: AZD0486 Bispecific monoclonal IgG4 antibody Other Name: TNB-486 Drug: R-mini-CHOP Intravenous administration: Rituximab 375 mg/m2, Cyclophosphamide 400 mg/m2, Doxorubicin 25 mg/m2, Vincristine 1 mg, and Oral administration: Prednisone 40 mg/m2 |