NCT06712355

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

A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide/Carboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 621 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (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).

Detailed description

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.

Conditions

• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pumitamig	Intravenous infusion
DRUG	Atezolizumab	Intravenous infusion
DRUG	Etoposide	Intravenous infusion and capsules
DRUG	Carboplatin (or cisplatin if carboplatin is not tolerated)	Intravenous infusion

Timeline

• Start date: 2025-02-03
• Primary completion: 2028-12-01
• Completion: 2029-03-01
• First posted: 2024-12-02
• Last updated: 2026-02-13

Locations

138 sites across 10 countries: United States, Australia, China, Germany, Japan, Poland, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study