A Phase IIIII Multisite Randomized Trial of BNT327 with Chemotherapy and Other Agents for First-line Non-small Cell Lung Cancer

What this Trial Is About

Researchers are studying the safety, effectiveness, and how the body processes pumitamig BNT327 combined with chemotherapy and other investigational treatments in people with first-line non-small cell lung cancer NSCLC. This Phase 23, multisite, randomized, open-label trial includes two substudies based on NSCLC subtypes, reflecting differences in standard chemotherapy choices. The study is sponsored by BioNTech SE and aims to better understand treatment options for this condition. Participants in each substudy enter a Phase 2 part where they are randomly assigned to one of two doses of pumitamig plus chemotherapy. Afterward, they may move to a Phase 3 part, where an independent committee continuously reviews safety data and tumor scan results. Study treatments include pumitamig, pembrolizumab, carboplatin, pemetrexed, and paclitaxel, all given via intravenous infusion. The study duration for each participant can be up to 64 months. During the trial, participants will undergo regular tumor assessments, safety monitoring for side effects, and quality-of-life evaluations using questionnaires. Researchers will track adverse events, treatment responses, progression-free survival, overall survival, and symptom changes up to approximately 5 years. Participants will have scheduled follow-ups for up to 90 days after treatment to monitor safety and treatment impact.

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer