Trial summary
This is a Phase III, multisite, randomized, double-blinded study to investigate BNT327 combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).
The study consists of a screening period (up to 21 days), an induction period followed by a maintenance period (until confirmed disease progression, intolerable toxicity, participant withdrawal, trial termination or up to 2 years [whichever occurs first]), and a follow-up (FU) period for all participants (2 safety FU visits and survival FU visits).
Eligible patients will be randomized (1:1:1) to the treatment arms (Arm 1, Arm 2, and Arm 3), until one arm stops accrual. Participants will then be randomized (1:1) in the remaining two treatment arms (Arm 1 and Arm 2 or Arm 3). The randomization will be stratified based on the following factors:
1) Brain metastases per investigator assessment;
2) Liver metastases per investigator assessment; and
3) Geography.
Trial details
Short title
BNT327-03
Diagnosis
Lung cancer
Type of treatment
Medical Oncology
Phase
III
Locations
Who can participate
Clinical trials can have restrictive criteria of who can and can’t participate, talk to your healthcare provider if you are interested in this clinical trial.