BNT327 NSCLC

A randomized phase 2/3 trial in first-line non-small cell lung cancer of BNT327 in combination with chemotherapy

Study Name:
A randomized phase 2/3 trial in first-line non-small cell lung cancer of BNT327 in combination with chemotherapy

Targeted Disease(s):
Lung Cancer

Purpose of Study:

The goal of this trial is to learn about the safety of a trial drug called BNT327 and whether it works compared to existing treatment for people with advanced non-small cell lung cancer who have not had treatment yet. BNT327 is designed to block two mechanisms the cancer uses to evade the immune system’s natural defense thereby aiming to enhance anti-tumor responses. More than 1000 patients have been treated with BNT327 in clinical trials to date. Multiple clinical trials are currently ongoing evaluating BNT327 either on its own or in combination with other treatments. The trial will be conducted in two portions: • The earlier portion of the trial will evaluate safety and efficacy of different doses of BNT327 in combination with chemotherapy and alone and how well it works compared to existing treatment. • The later portion of the trial will evaluate the safety and effectiveness of BNT327 in combination with chemotherapy and alone, compared to pembrolizumab (a lung cancer treatment that’s already approved in many countries).

Study Dates:
January 1, 2025 - December 31, 2030

Type of Study:
Pre-Market

Study Design:
Controlled Design

Study Location:
Nationwide

Lead Institution:
BioNTech

ClinicalTrails.gov Identifier:
NCT06712316

Register for Trial
Freedom From Smoking Clinic - Chardon, OH
Chardon, OH | Sep 10, 2025
LUNG FORCE Walk - Cleveland, OH
Cleveland, OH | Sep 28, 2025