Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
Recruiting now · Phase 1
Conditions studied: Non-Small Cell Lung Cancer
In brief
This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor or a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) in participants with non-small cell lung cancer (NSCLC). The study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The study will enroll participants with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 10, unresectable NSCLC Stage III in Cohorts 5 and 11, resectable NSCLC of Stage II and III in Cohort 6, advanced/metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced/metastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK/RET. Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
Key facts
- Study ID
- NCT05142189
- Run by
- BioNTech SE
- People needed
- 320
- Starts
- 2022-06-17
- Expected to finish
- 2031-11-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, United Kingdom (enrolling)
- Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
- Ohio State University — Columbus, Ohio, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- NEXT Virginia — Fairfax, Virginia, United States (enrolling)
- Scientia Clinical Research — Randwick, New South Wales, Australia (enrolling)
- Royal North Shore Hospital — Sydney, New South Wales, Australia (enrolling)
- Cancer Research SA — Adelaide, South Australia, Australia (enrolling)
- Monash Health — Clayton, Victoria, Australia (enrolling)
- Universitätsklinikum Köln — Cologne, Germany (enrolling)
- Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF) — Frankfurt, Germany (enrolling)
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (enrolling)
- Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR — Mainz, Germany (enrolling)
- The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool, United Kingdom (enrolling)
- Guy's and St Thomas NHS Foundation Trust — London, United Kingdom (enrolling)
- University College London Hospitals NHS Foundation Trust — London, United Kingdom (enrolling)
- University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States (enrolling)
- National Institute of Oncology — Budapest, Hungary (enrolling)
- Clinexpert Ltd — Gyöngyös, Hungary (enrolling)
- Uniwersyteckie Centrum Kliniczne — Gdansk, Poland (enrolling)
- Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie — Olsztyn, Poland (enrolling)
- NZOZ Medpolonia Sp. Z o.o — Poznan, Poland (enrolling)
- Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol — Badalona, Spain (enrolling)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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