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Clinical Trials in South Korea / NCT07215585
Recruiting Phase 3

AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

NCT07215585 · tracked via the Priya Life Science South Korea tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-11-11
Last updated
2026-06-18

Condition(s) studied

Large B-cell Lymphoma

Investigational drug(s) / intervention(s)

AZD0486 →R-mini-CHOP →

AZD0486: Bispecific monoclonal IgG4 antibody

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

Study 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

Sex
ALL
Min age
65 Years
Max age
130 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • SRI - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. — Up to 1 year
    Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
  • SRI - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. — Up to 1 year
    AEs leading to study treatment discontinuation or dose modification based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
  • SRI - Determination of the recommended Phase III dose (RP3D) — Up to 1 year
    The RP3D will be the dose of AZD0486 selected for the Phase 3 part based on safety data compiled during the Safety Run-In part
  • Phase 3 - To demonstrate the superiority of R-mini-CHOP x2 followed by AZD0486 compared to R-mini-CHOP x6 regimen. — Up to 7 years
    Progression-free Surival (PFS), based on Lugano 2014 Response Criteria.

Trial sites (68)

FacilityCityRegionStatus
Research Site Clayton Australia Not Yet Recruiting
Research Site Macquarie University Australia Withdrawn
Research Site Melbourne Australia Recruiting
Research Site Nedlands Australia Not Yet Recruiting
Research Site Waratah Australia Not Yet Recruiting
Research Site Antwerp Belgium Withdrawn
Research Site Brussels Belgium Not Yet Recruiting
Research Site Ghent Belgium Recruiting
Research Site Leuven Belgium Recruiting
Research Site Roeselare Belgium Suspended
Research Site Yvoir Belgium Recruiting
Research Site Porto Alegre Brazil Recruiting
Research Site São Paulo Brazil Recruiting
Research Site Calgary Alberta Recruiting
Research Site Victoria British Columbia Not Yet Recruiting
Research Site Hamilton Ontario Not Yet Recruiting
Research Site Ottawa Ontario Recruiting
Research Site Beijing China Recruiting
Research Site Changchun China Recruiting
Research Site Chengdu China Recruiting
Research Site Chongqing China Not Yet Recruiting
Research Site Fuzhou China Not Yet Recruiting
Research Site Guangzhou China Recruiting
Research Site Guangzhou China Not Yet Recruiting
Research Site Haikou China Not Yet Recruiting
Research Site Hefei China Not Yet Recruiting
Research Site Jinan China Recruiting
Research Site Kunming China Not Yet Recruiting
Research Site Nanchang China Not Yet Recruiting
Research Site Nanning China Not Yet Recruiting
Research Site Nantong China Withdrawn
Research Site Shanghai China Recruiting
Research Site Shanghai China Recruiting
Research Site Wuhan China Not Yet Recruiting
Research Site Xiamen China Not Yet Recruiting
Research Site Hong Kong Hong Kong Recruiting
Research Site Lai Chi Kok Hong Kong Not Yet Recruiting
Research Site Shatin Hong Kong Withdrawn
Research Site Akashi Japan Not Yet Recruiting
Research Site Bunkyō City Japan Recruiting

+ 28 more sites — see the full list on the official registry below.

More AstraZeneca trials in South Korea

Savolitinib vs. Sunitinib in MET-driven PRCC. Active, not recruiting
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus Recruiting
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations Active, not recruiting
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Active, not recruiting
Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT Recruiting

Other trials for the same condition

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma Active, not recruiting
A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies Recruiting
An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma Active, not recruiting
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07215585 on ClinicalTrials.gov ↗ ← All trials in South Korea