RecruitingPhase 3NCT07215585

AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

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)

Sponsor

AstraZeneca

Enrollment

420 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Large B-cell Lymphoma

Summary

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.

Eligibility

Min Age: 65 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AZD0486 as a first-line treatment for elderly or medically unfit patients with large B-cell lymphoma (a type of aggressive blood cancer) who cannot safely receive standard full-dose chemotherapy (R-CHOP). **You may be eligible if...** - You are 80 or older, OR you are 65–79 years old and considered medically unfit, AND your doctor has determined you are not a candidate for full-dose R-CHOP - You have newly diagnosed large B-cell lymphoma confirmed by biopsy - Your lymphoma is measurable on scans and at least Stage I bulky (7.5 cm or larger) to Stage IV - You are reasonably functional (ECOG 0–2) - Your blood, liver, kidney, and heart function are adequate **You may NOT be eligible if...** - You have certain rare subtypes of lymphoma (plasmablastic lymphoma, post-transplant lymphoma, or concurrent indolent lymphoma) - You have a history of CNS involvement by lymphoma - You have active or uncontrolled infection, or significant heart problems - You have received any prior anti-lymphoma treatment (except steroids for symptoms) - You require long-term immune-suppressing medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD0486

Bispecific monoclonal IgG4 antibody

DRUGR-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

Locations(62)

Research Site

Melbourne, Australia

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Nedlands, Australia

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Waratah, Australia

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Antwerp, Belgium

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Brussels, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Roeselare, Belgium

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Yvoir, Belgium

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Porto Alegre, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Ottawa, Ontario, Canada

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Beijing, China

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Changchun, China

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Chengdu, China

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Chongqing, China

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Fuzhou, China

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Guangzhou, China

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Guangzhou, China

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Haikou, China

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Hefei, China

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Jinan, China

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Kunming, China

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Nanchang, China

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Nanning, China

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Nantong, China

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Shanghai, China

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Shanghai, China

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Wuhan, China

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Xiamen, China

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Hong Kong, Hong Kong

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Lai Chi Kok, Hong Kong

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Shatin, Hong Kong

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Akashi, Japan

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Bunkyō City, Japan

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Himeji-shi, Japan

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Kōtoku, Japan

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Kumamoto, Japan

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Matsumoto-shi, Japan

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Matsuyama, Japan

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Meguro-ku, Japan

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Nagoya, Japan

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Osaka, Japan

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Osaka, Japan

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Otaki-Shi, Japan

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Sunto-gun, Japan

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Yamagata, Japan

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Yokohama, Japan

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Kielce, Poland

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Krakow, Poland

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Lodz, Poland

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Lublin, Poland

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Wroclaw, Poland

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Seoul, South Korea

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Seoul, South Korea

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Ankara, Turkey (Türkiye)

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Antalya, Turkey (Türkiye)

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Glasgow, Scotland, United Kingdom

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London, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Nottingham, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07215585

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