BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)

Condition(s) studied

Investigational drug(s) / intervention(s)

BL-M14D1 and Atezolizumab: BL-M14D1 administered in combination with atezolizumab. BL-M14D1 will be given intravenously at the protocol-specified dose and schedule. Atezolizumab will be administered intravenously according to the approved dosing regimen.

Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin: Carboplatin and etoposide will be administered intravenously in combination with atezolizumab for induction therapy, followed by maintenance treatment with atezolizumab with or without lurbinectedin per protocol.

Study summary

The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

Eligibility

Primary outcome measure(s)

• Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) — Up to approximately 2 years
  Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression, as assessed by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause, whichever occurs first.

Trial sites (62)

+ 22 more sites — see the full list on the official registry below.