A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer
← catalyst calendarNCT05800015 · readout in 1,246 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
160actual
Sites
76
Countries
Australia, Canada, Georgia +7
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 | 2023-08-08 | actual | When the study began enrolling |
| Primary completion | 2030-01-16 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-12-23 | estimated | The whole study's end, after follow-up |
| First posted | 2023-04-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-15 | 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
- Drug: fianlimab — also filed as REGN3767
- Drug: cemiplimab — also filed as REGN2810, Libtayo
- Drug: Pemetrexed — also filed as Alimta
- Drug: Paclitaxel
- Drug: Carboplatin — also filed as Paraplatin
- Drug: Cisplatin — also filed as Platinol
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFObjective response rate (ORR) as assessed by blinded independent review committee (BICR) using RECIST 1.1
measured Up to 136 Weeks
Overall Survival (OS)
measured Up to 5 years
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