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)
← catalyst calendarNCT05557591 · readout in 524 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →. With BioNTech SE.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
51actual
Sites
52
Countries
Georgia, Germany, South Korea +4
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 | 2023-04-21 | actual | When the study began enrolling |
| Primary completion | 2028-01-26 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-05-16 | estimated | The whole study's end, after follow-up |
| First posted | 2022-09-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Non-Small Cell Lung Cancer
Interventions
- Drug: BNT116
- Drug: Cemiplimab — also filed as REGN2810, Libtayo
Primary outcome
what the primary-completion date above is the date OFObjective response rate (ORR) as assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
measured Up to 136 weeks from randomization
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