MedTrace Logo

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

NCT05800015 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 950

Last updated 2026-01-22

No results posted yet for this study

Summary

This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". 'Investigational' means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advanced non-small cell lung cancer (NSCLC).

The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, in comparison with cemiplimab and chemotherapy.

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 your blood at different times
* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
* How administering the study drugs might improve your quality of life

Conditions

Interventions

DRUG

fianlimab

Administered intravenously (IV) every 3 weeks (Q3W)

DRUG

cemiplimab

Administered IV Q3W

DRUG

Pemetrexed

IV Infusion, Q3W

DRUG

Paclitaxel

IV Infusion, Q3W

DRUG

Carboplatin

IV Infusion, Q3W

DRUG

Cisplatin

IV infusion, Q3W

DRUG

Placebo

IV infusion, 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
2023-08-08
Primary Completion
2030-01-16
Completion
2031-12-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Georgia
  • Israel
  • Malaysia
  • South Korea
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT05800015 on ClinicalTrials.gov