AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL
NCT07215585 · SOUNDTRACK-D2 Phase 3Recruiting
- Lead sponsor
- AstraZeneca (Industry)
- Enrollment
- 420 (estimated)
- Start date
- 11 Nov 2025
- Primary completion
- 10 Jun 2030 (estimated)
- Study completion
- 29 Jul 2033
- Last update posted
- 9 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 3
Interventions
- AZD0486 Drug
- R-mini-CHOP Drug
Conditions and primary outcome
- Large B-cell Lymphoma
Primary outcome
SRI - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. (Up to 1 year); SRI - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. (Up to 1 year); SRI - Determination of the recommended Phase III dose (RP3D) (Up to 1 year); 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)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT07215585.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT07215585 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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