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Clinical Trials in Germany / NCT06465329
Active, not recruiting Phase 2

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)

NCT06465329 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2024-11-18
Last updated
2026-08-24

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Cemiplimab →Platinum-based chemotherapyREGN7075 →

Cemiplimab: Intravenous (IV) infusion administration

Platinum-based chemotherapy: IV infusion

REGN7075: IV infusion

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)?

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (47)

FacilityCityRegionStatus
University of California Irvine Orange California
Orchard Healthcare Research Inc. Skokie Illinois
Karmanos Cancer Institute Detroit Michigan
Detroit Clinical Research Center Farmington Hills Michigan
Oncology Hematology Care Clinical Trials LLC Cincinnati Ohio
Providence Portland Medical Center Portland Oregon
University Of Nebraska Medical Center Portland Oregon
Lifespan Cancer Institute Providence Rhode Island
Prairie Lakes Healthcare System Watertown South Dakota
University of Tennessee Medical Center Knoxville Tennessee
Sarah Cannon Research Institute (SCRI) Oncology Partners Nashville Tennessee
BRCC/Oncology & Hematology Associates of SW Virginia Blacksburg Virginia
Oncology Clinical Research Center Cachoeiro de Itapemirim Espírito Santo
Instituto Mario Penna Belo Horizonte Minas Gerais
Instituto Sul Mineiro De Oncologia LTDA Pouso Alegre Minas Gerais
Instituto de Medicina Integral Professor Fernando Figueira Recife Pernambuco
Liga Norte Riograndense Contra o Cancer Natal Rio Grande do Norte
Hospital Mae de Deus Integrated Oncology Center Porto Alegre Rio Grande do Sul
Hospital Sao Lucas da PUCRS Porto Alegre Rio Grande do Sul
Ynova Pesquisa Clinica Florianópolis Santa Catarina
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto São José do Rio Preto São Paulo
Unimed Sorocaba Sorocaba São Paulo
Hospital Alemao Oswaldo Cruz São Paulo Brazil
CHU Rennes Rennes Brittany Region
Centre Hospitalier Intercommunal Toulon - CHITS Toulon Var
Centre Hospitalier de la Cote Basque Bayonne France
Clinique Belharra Bayonne France
CHU Grenoble Alpes Grenoble France
Montpellier Academic Hospital Montpellier France
Institut Curie Paris Île-de-France Region
Klinikum Kassel GmbH, Hauttumorzentrum Kassel Hesse
University Medicine Gottingen Göttingen Lower Saxony
University of Leipzig Leipzig Saxony
University Hospital RWTH Aachen Aachen Germany
Catalan Instituye of Oncology Badalona Badalona Barcelona
Hospital Valdecilla Santander Cantabria
Hospital Universitario Insular de Gran Canaria Las Palmas de Gran Canaria Las Palmas
Clinica Universidad de Navarra Pamplona Navarre
MD Anderson Cancer Center Madrid Spain
Hospital Universitario Clinico San Carlos Madrid Spain

+ 7 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile →

More Regeneron Pharmaceuticals trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06465329 on ClinicalTrials.gov ↗ ← All trials in Germany