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ACTIVE NOT RECRUITING Phase 2

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 · View on ClinicalTrials.gov ↗

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

Interventions

  • DRUG Carboplatin
  • DRUG Cemiplimab
  • DRUG Pemetrexed
  • DRUG Paclitaxel
  • DRUG Fianlimab

Study Locations (20)

Victoria

  • Eastern Health — Box Hill
  • St Vincent's Hospital — Fitzroy

Nouvelle-Aquitaine

  • Centre Hospitalier Universitaire (CHU) Bordeaux — Bordeaux
  • CHU Limoges — Limoges

Florida

  • Clermont Oncology Center — Clermont

Illinois

  • University of Illinois — Chicago

Kansas

  • University of Kansas Cancer Center-Westwood — Westwood

Michigan

  • Henry Ford Health System — Detroit

Missouri

  • Mercy South — St Louis

New York

  • University of Rochester — Rochester

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2024-07-16
Est. Completion 2029-11-04
Phase Phase 2

Sponsor

Regeneron Pharmaceuticals

290 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06161441

The ClinicalTrials.gov registry entry for NCT06161441 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Resectable Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06161441 reports 20 study locations spanning 18 distinct geographic areas — top geographies include Victoria, Nouvelle-Aquitaine, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06161441 about?

NCT06161441 is a clinical study titled "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". 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...

What is the current status of trial NCT06161441?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2024-07-16. Estimated completion is 2029-11-04.

What conditions does trial NCT06161441 study?

This clinical trial studies the following conditions: Resectable Non-small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06161441?

The interventions under investigation include: Carboplatin (DRUG), Cemiplimab (DRUG), Pemetrexed (DRUG), Paclitaxel (DRUG), Fianlimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06161441?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06161441 being conducted?

This trial has 20 study locations across Florida, Illinois, Kansas, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial