Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

Summary

Objectives

There are two stages in this study: Stage 1 will have two treatment arms and one control
arm, and Stage 2 will have a treatment arm and a control arm. The control arms in Stages
1 and 2 are the same.

Each stage of 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, study 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).

In Stage 1, eligible participants will be randomized (1:1:1) to the arms. In Stage 2,
participants will then be randomized (1:1) to the arms. The randomization will be
stratified based on the following factors:

1. Brain or liver metastases per investigator assessment (presence versus absence);

2. Smoking status (smoker versus never-smoker); and

3. Geography.

Participants will be allowed to switch to cisplatin if carboplatin is not tolerated at
the investigator's discretion.