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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

NCT06161441 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2026-01-12

No results posted yet for this study

Summary

This study is researching an experimental drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery.

The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs
* How much of each study drug is in the blood at different times
* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
* How administering the study drugs might affect quality of life

Conditions

  • Resectable Non-small Cell Lung Cancer

Interventions

DRUG

Fianlimab

Administered intravenously (IV) every 3 weeks (Q3W)

DRUG

Cemiplimab

Administered IV Q3W

DRUG

Pemetrexed

Administered IV Q3W

DRUG

Paclitaxel

Administered IV Q3W

DRUG

Carboplatin

Administered IV Q3W

DRUG

Cisplatin

Administered IV Q3W

DRUG

Placebo

Administered IV Q3W

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-16
Primary Completion
2026-04-17
Completion
2029-11-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Chile
  • France
  • Georgia
  • Germany
  • Italy
  • Malaysia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06161441 on ClinicalTrials.gov