A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
← catalyst calendarNCT05785767 · readout in 405 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
149actual
Sites
106
Countries
Australia, Canada, Georgia +8
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 | 2023-06-30 | actual | When the study began enrolling |
| Primary completion | 2027-09-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-09-28 | estimated | The whole study's end, after follow-up |
| First posted | 2023-03-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-02 | 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: fianlimab — also filed as REGN3767
- Drug: cemiplimab — also filed as REGN2810, Libtayo
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFObjective response rate (ORR) as assessed by blinded independent central review (BICR), using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
measured Up to 136 weeks
Permalink · REGN's whole pipeline · Catalyst calendar · Every registered study · What changed