Active Not RecruitingPhase 2NCT06465329
Official study title

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

Study summary

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned. The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug. The study is also looking at several other research questions, including: * What are the side effects associated with the investigational treatments in comparison to the control treatment? * Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed? * How much of the study drug(s) are in the blood at a given time? * Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)?

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCemiplimab and Platinum-based chemotherapy

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 24, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2

Interventional

Where is it offered?47 U.S. locations

Locations may change over time.

Who runs it?Regeneron Pharmaceuticals

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Regeneron Pharmaceuticals
Interventions being studied
Drug: Cemiplimab; Drug: Platinum-based chemotherapy; Drug: REGN7075
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

General Key 1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol 2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol 4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1 5. Adequate organ and bone marrow function, as described in the protocol General Key

Reasons someone may not be able to joinExclusion criteria

1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol 2. Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol 3. Presence of grade≥ 2 peripheral neuropathy 4. Another malignancy that is progressing or requires active treatment, as described in the protocol Arm Specific

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California IrvineOrange, California
  • Orchard Healthcare Research Inc.Skokie, Illinois
  • Karmanos Cancer InstituteDetroit, Michigan
  • Detroit Clinical Research CenterFarmington Hills, Michigan
  • Oncology Hematology Care Clinical Trials LLCCincinnati, Ohio
  • Providence Portland Medical CenterPortland, Oregon
  • University Of Nebraska Medical CenterPortland, Oregon
  • Lifespan Cancer InstituteProvidence, Rhode Island
  • Prairie Lakes Healthcare SystemWatertown, South Dakota
  • University of Tennessee Medical CenterKnoxville, Tennessee
  • Sarah Cannon Research Institute (SCRI) Oncology PartnersNashville, Tennessee
  • BRCC/Oncology & Hematology Associates of SW VirginiaBlacksburg, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 24, 2026. Always confirm current availability with the study team.

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