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New lung cancer cocktail aims to shrink tumors before surgery

NCT ID NCT06465329

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This study tests whether adding a third drug to standard immunotherapy (cemiplimab) plus chemotherapy works better for people with early-stage non-small cell lung cancer who can have surgery. About 120 adults will receive treatment before and after their operation. The main goal is to see if the extra drug helps eliminate more cancer cells in the removed tumor tissue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

General Key Inclusion Criteria: 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 Exclusion 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 Exclusion Criteria: Arm 1: 1. Grade ≥3 hypercalcemia, as defined in the protocol 2. Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol 3. Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol Note: Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • BRCC/Oncology & Hematology Associates of SW Virginia

    Blacksburg, Virginia, 24060, United States

  • CHU Grenoble Alpes

    Grenoble, 38330, France

  • CHU Rennes

    Rennes, Brittany Region, 35033, France

  • Catalan Instituye of Oncology Badalona

    Badalona, Barcelona, 08916, Spain

  • Centre Hospitalier Intercommunal Toulon - CHITS

    Toulon, Var, 83055, France

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100, France

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinique Belharra

    Bayonne, 64100, France

  • Consorci Hospital General Universitario de Valencia

    Valencia, 46014, Spain

  • Detroit Clinical Research Center

    Farmington Hills, Michigan, 48334, United States

  • Florya Medical Park Hospital

    Istanbul, 34295, Turkey (Türkiye)

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01323-903, Brazil

  • Hospital Clinico Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital Clinico Universitario Valencia

    Valencia, 46010, Spain

  • Hospital Mae de Deus Integrated Oncology Center

    Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Virgen del Rocio

    Seville, 41013, Spain

  • Institut Curie

    Paris, Île-de-France Region, 75005, France

  • Instituto Mario Penna

    Belo Horizonte, Minas Gerais, 30380-472, Brazil

  • Instituto Sul Mineiro De Oncologia LTDA

    Pouso Alegre, Minas Gerais, 37554-238, Brazil

  • Instituto de Medicina Integral Professor Fernando Figueira

    Recife, Pernambuco, 50070-902, Brazil

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Klinikum Kassel GmbH, Hauttumorzentrum

    Kassel, Hesse, 34125, Germany

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02903, United States

  • Liga Norte Riograndense Contra o Cancer

    Natal, Rio Grande do Norte, 59060-195, Brazil

  • MD Anderson Cancer Center

    Madrid, 28033, Spain

  • Montpellier Academic Hospital

    Montpellier, 34295, France

  • Oncology Clinical Research Center

    Cachoeiro de Itapemirim, Espírito Santo, 29306014, Brazil

  • Oncology Hematology Care Clinical Trials LLC

    Cincinnati, Ohio, 45245, United States

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077, United States

  • Prairie Lakes Healthcare System

    Watertown, South Dakota, 57201, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    Nashville, Tennessee, 37203, United States

  • Unimed Sorocaba

    Sorocaba, São Paulo, 18065-100, Brazil

  • University Hospital RWTH Aachen

    Aachen, 52074, Germany

  • University Medicine Gottingen

    Göttingen, Lower Saxony, 37083, Germany

  • University Of Nebraska Medical Center

    Portland, Oregon, 97213, United States

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Leipzig

    Leipzig, Saxony, 04103, Germany

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • Ynova Pesquisa Clinica

    Florianópolis, Santa Catarina, 88020-210, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.