BNT116

DRUG3 trials

Sponsors

Regeneron Pharmaceuticals Inc., BioNTech SE, Regeneron Pharmaceuticals

Conditions

Advanced Non-Small Cell Lung CancerNon-Small Cell Lung Cancer

Phase 1

Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

RecruitingNCT05142189

BioNTech SENon-Small Cell Lung Cancer

Start: 2022-06-17End: 2031-11-01Target: 320Updated: 2026-07-22

Phase 2

A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)

Active, not recruitingNCT05557591

Regeneron PharmaceuticalsAdvanced Non-Small Cell Lung Cancer

Start: 2023-04-21End: 2028-05-16Updated: 2026-05-06

A PHASE 2 STUDY OF CEMIPLIMAB (ANTI-PD-1 ANTIBODY) IN COMBINATION WITH BNT116 (FIXVAC LUNG) VERSUS CEMIPLIMAB MONOTHERAPY IN FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) WITH TUMORS EXPRESSING PD-L1 ≥50%.

RecruitingCTIS2023-503221-19-00

Regeneron Pharmaceuticals Inc.Advanced Non-Small Cell Lung Cancer

Start: 2024-04-18Target: 35Updated: 2025-06-02

Related Papers

Abstract CT176: ctDNA as a prognostic and pharmacodynamic biomarker following first- or later-line treatment of advanced NSCLC with BNT116 + cemiplimab

Cancer Research2026-04-17

Groundbreaking mRNA Lung Cancer Vaccine Trials: A New Dawn in Cancer Treatment

Current Cancer Drug Targets2025-02-179 citations

597 Preliminary results from LuCa-MERIT-1, a first-in-human Phase I trial evaluating the fixed antigen RNA vaccine BNT116 in patients with advanced non-small cell lung cancer

Regular and Young Investigator Award Abstracts2023-10-318 citations

700 LuCa-MERIT-1: First-in-human open label dose confirmation trial evaluating safety, tolerability, and efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer

Regular and Young Investigator Award Abstracts2022-11-01