Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
← catalyst calendarNCT05142189 · readout ≤ 1,289 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
320estimated
Sites
45
Countries
Australia, Germany, Hungary +5
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-06-17 | actual | When the study began enrolling |
| Primary completion | Feb 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2031 | estimated | The whole study's end, after follow-up |
| First posted | 2021-12-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Non-Small Cell Lung Cancer
Interventions
- Biological: BNT116
- Biological: Cemiplimab
- Drug: Docetaxel
- Drug: Carboplatin
- Drug: Paclitaxel
- Biological: BNT316
- Biological: anti-B7-H3 antibody conjugated to topoisomerase I inhibitor
- Biological: anti-HER3 antibody conjugated to topoisomerase I inhibitor
- Biological: Bispecific antibody for PD-L1 and VEGF-A
- Biological: Osimertinib
- Biological: ALK-inhibitor or RET-inhibitor
Primary outcomes
what the primary-completion date above is the date OFCohorts 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, EGFR and ALK/RET: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation Period
measured From first dose of IMP up to 21 days
Cohorts 1 to 11, EGFR and ALK/RET: Occurrence of Treatment-Emergent Adverse Events (TEAEs) Reported by Relationship, Seriousness, and Grade
measured up to 27 months
Cohort 6 only: Occurrence of Post-Surgical Adverse Events (AEs) Related to BNT116 and Cemiplimab
measured up to 27 months
Cohort 6 only: Occurrence of Treatment-Related Delays to Surgery More Than 9 weeks Post the Last Dose of Neo-Adjuvant Treatment
measured up to 6 months
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