A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

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NCT06161441 · readout in 5 d

Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.

Phase

Phase 2

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

195actual

Sites

123

Countries

Australia, Chile, France +9

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

2024-07-16

actual

When the study began enrolling

Primary completion

2026-08-24

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2029-11-04

estimated

The whole study's end, after follow-up

First posted

2023-12-07

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-10

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Resectable 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 — also filed as Taxol
Drug: Carboplatin — also filed as Paraplatin
Drug: Cisplatin — also filed as Platinol
Drug: Placebo

Primary outcome

what the primary-completion date above is the date OF

Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples

measured Up to 24 months

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