Actively Recruiting
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)
Led by Regeneron Pharmaceuticals · Updated on 2026-02-12
120
Participants Needed
49
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)?
CONDITIONS
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histologically confirmed stage II to IIIB non-small cell lung cancer considered resectable with curative intent
- Measurable disease per RECIST criteria version 1.1
- Available formalin-fixed paraffin-embedded tumor sample blocks for submission
- Eastern Cooperative Oncology Group Performance Status of 0 to 1
- Adequate organ and bone marrow function as described in the protocol
You will not qualify if you...
- Previous systemic anti-cancer therapy or radiotherapy for the current tumor
- Known EGFR or ALK oncogenic alterations in the tumor prior to randomization
- Grade 2 or higher peripheral neuropathy
- Another malignancy that is progressing or requires active treatment
- For Arm 1: Grade 3 or higher hypercalcemia
- For Arm 1: Central nervous system pathology increasing risk of immune effector cell-associated neurotoxicity syndrome
- For Arm 1: Marked baseline prolongation of QT/QTc interval or risk factors for prolonged QTc
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
2
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60077
Actively Recruiting
3
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
4
Detroit Clinical Research Center
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
5
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
6
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
7
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
8
University Of Nebraska Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
9
Lifespan Cancer Institute
Providence, Rhode Island, United States, 02903
Actively Recruiting
10
Prairie Lakes Healthcare System
Watertown, South Dakota, United States, 57201
Actively Recruiting
11
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
12
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
13
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
BRCC/Oncology & Hematology Associates of SW Virginia
Blacksburg, Virginia, United States, 24060
Actively Recruiting
15
Oncology Clinical Research Center
Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29306014
Actively Recruiting
16
Instituto Mario Penna
Belo Horizonte, Minas Gerais, Brazil, 30380-472
Actively Recruiting
17
Instituto Sul Mineiro De Oncologia LTDA
Pouso Alegre, Minas Gerais, Brazil, 37554-238
Actively Recruiting
18
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, Brazil, 50070-902
Actively Recruiting
19
Liga Norte Riograndense Contra o Cancer
Natal, Rio Grande do Norte, Brazil, 59060-195
Actively Recruiting
20
Hospital Mae de Deus Integrated Oncology Center
Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
Actively Recruiting
21
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
22
Ynova Pesquisa Clinica
Florianópolis, Santa Catarina, Brazil, 88020-210
Actively Recruiting
23
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
24
Unimed Sorocaba
Sorocaba, São Paulo, Brazil, 18065-100
Actively Recruiting
25
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil, 01323-903
Actively Recruiting
26
CHU Rennes
Rennes, Brittany Region, France, 35033
Actively Recruiting
27
Centre Hospitalier Intercommunal Toulon - CHITS
Toulon, Var, France, 83055
Actively Recruiting
28
Centre Hospitalier de la Cote Basque
Bayonne, France, 64100
Actively Recruiting
29
Clinique Belharra
Bayonne, France, 64100
Actively Recruiting
30
CHU Grenoble Alpes
Grenoble, France, 38330
Actively Recruiting
31
Montpellier Academic Hospital
Montpellier, France, 34295
Actively Recruiting
32
Institut Curie
Paris, Île-de-France Region, France, 75005
Actively Recruiting
33
Klinikum Kassel GmbH, Hauttumorzentrum
Kassel, Hesse, Germany, 34125
Actively Recruiting
34
University Medicine Gottingen
Göttingen, Lower Saxony, Germany, 37083
Actively Recruiting
35
University of Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
36
University Hospital RWTH Aachen
Aachen, Germany, 52074
Actively Recruiting
37
Catalan Instituye of Oncology Badalona
Badalona, Barcelona, Spain, 08916
Actively Recruiting
38
Hospital Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
39
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Actively Recruiting
40
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
41
MD Anderson Cancer Center
Madrid, Spain, 28033
Actively Recruiting
42
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
43
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
44
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
45
Hospital Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
46
Hospital Clinico Universitario Valencia
Valencia, Spain, 46010
Actively Recruiting
47
Consorci Hospital General Universitario de Valencia
Valencia, Spain, 46014
Actively Recruiting
48
Hospital Clinico Lozano Blesa
Zaragoza, Spain, 50009
Actively Recruiting
49
Florya Medical Park Hospital
Istanbul, Turkey (Türkiye), 34295
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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