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Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
NCT05142189 · View on ClinicalTrials.gov ↗
Study Summary
This first-in-human (FIH) trial 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, 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 trial will comprise of several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The trial 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, and resectable NSCLC of Stage II and III in Cohort 6.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Paclitaxel
- BIOLOGICAL Cemiplimab
- BIOLOGICAL BNT116
Study Locations (20)
Other
- Universitätsklinikum Köln — Cologne
- Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF) — Frankfurt
- University Medical Center Hamburg-Eppendorf — Hamburg
- Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR — Mainz
- ICON-PRA Budapest, Fázis 1 Vizsgálóhely — Budapest
- Semmelweis Egyetem ÁOK Belgyógyászati és Onkológiai Klinika — Budapest
- National Institute of Oncology — Budapest
- Clinexpert Ltd — Gyöngyös
- Uniwersyteckie Centrum Kliniczne — Gdansk
- Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie — Olsztyn
- NZOZ Medpolonia Sp. Z o.o — Poznan
Kentucky
- University of Kentucky Chandler Medical Center — Lexington
- Norton Cancer Institute — Louisville
New South Wales
- Scientia Clinical Research — Randwick
- Royal North Shore Hospital — Sydney
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore
Texas
- MD Anderson Cancer Center — Houston
Virginia
- NEXT Virginia — Fairfax
South Australia
- Cancer Research SA — Adelaide
Victoria
- Monash Health — Clayton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2022-06-17 |
| Est. Completion | 2031-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05142189
The ClinicalTrials.gov registry entry for NCT05142189 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05142189 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Kentucky, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05142189 about?
NCT05142189 is a clinical study titled "Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer". This first-in-human (FIH) trial 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,...
What is the current status of trial NCT05142189?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 280 participants. The study started on 2022-06-17. Estimated completion is 2031-11.
What conditions does trial NCT05142189 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05142189?
The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Paclitaxel (DRUG), Cemiplimab (BIOLOGICAL), BNT116 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05142189?
This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05142189 being conducted?
This trial has 20 study locations across Kentucky, Maryland, Texas, Virginia, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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