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)

Condition studied

Large B-cell Lymphoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Safety Run in: Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest;, Safety Run in: AEs/AEs leading to discontinuation or dose modification of AZD0486, Safety Run in: Clinically significant alterations in vital signs and abnormal laboratory parameters, Phase 3: PFS defined as the time from date of randomisation until disease progression as per Lugano 2014 as assessed by BICR, or death due to any cause

Endpoint detail

Safety Run in: ORR, CR Rate, DoR, DoCR, PFS, OS, Safety Run in: Concentration of AZD0486 in serum and PK parameters as data permits following R-mini-CHOP, Safety Run in: Summary of pre-existing and treatment induced ADAs for AZD0486 and the impact on PK, efficacy or safety, Phase 3: OS, Phase 3: ORR, CR rate, DoR, DoCR, PFS, PFS2, TFST, Phase 3: AEs, SAEs, AESIs, events of clinical interest, AEs leading to study treatment discontinuation or dose modification, Phase 3: Concentration of AZD0486 in serum and PK parameters as data permits following R-mini-CHOP, Phase 3: Summary of pre-existing and treatment induced ADAs for AZD0486 (positive or negative, titres) and the impact on PK, efficacy or safety, Phase 3: eCOA: - Proportion reporting different levels of pain and tirednesswhile on treatment using items from the FACT-LymS subsetfor all dosed participants, Phase 3: eCOA: - Proportion reporting each level of overall side effect bother on the PGI-TT, while on treatment for all dosed participants, Phase 3: eCOA: - Change from baseline on lymphoma-specific concerns based on FACT-LymS scores for all randomised participants, Phase 3: eCOA: - Change from baseline on overall HRQoL (based on QL2 item scores) for all randomised participants