Phase
Condition
Non-small Cell Lung Cancer
Treatment
REGN7075
Platinum-based chemotherapy
Cemiplimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
General Key Inclusion Criteria:
Histologically confirmed stage II through IIIB (N2) NSCLC, that is consideredresectable with curative intent, as described in the protocol
Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST)criteria version 1.1
Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks forsubmission, as described in the protocol
Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
Adequate organ and bone marrow function, as described in the protocol
Exclusion
General Key Exclusion Criteria:
Any systemic anti-cancer therapy or radiotherapy for the current tumor, as describedin the protocol
Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR)or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, asdescribed in the protocol
Presence of grade≥ 2 peripheral neuropathy
Another malignancy that is progressing or requires active treatment, as described inthe protocol
Arm Specific Exclusion Criteria:
Arm 1:
Grade ≥3 hypercalcemia, as defined in the protocol
Any central nervous system (CNS) pathology that could increase the risk of immuneeffector cell-associated neurotoxicity syndrome (ICANS), as described in theprotocol
Has marked baseline prolongation of the time from the start of the Q wave to the endof the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or riskfactors for prolonged QTc, as described in the protocol
Note: Other protocol-defined Inclusion/Exclusion criteria apply.
Study Design
Connect with a study center
Oncology Clinical Research Center
Cachoeiro de Itapemirim 3468376, Espírito Santo 3463930 29306014
BrazilActive - Recruiting
Instituto Mario Penna
Belo Horizonte 3470127, Minas Gerais 3457153 30380-472
BrazilActive - Recruiting
Instituto Sul Mineiro De Oncologia LTDA
Pouso Alegre 3452525, Minas Gerais 3457153 37554-238
BrazilActive - Recruiting
Instituto de Medicina Integral Professor Fernando Figueira
Recife 3390760, Pernambuco 3392268 50070-902
BrazilActive - Recruiting
Liga Norte Riograndense Contra o Cancer
Natal 3394023, Rio Grande do Norte 3390290 59060-195
BrazilActive - Recruiting
Hospital Mae de Deus Integrated Oncology Center
Porto Alegre 3452925, Rio Grande do Sul 3451133 90110-270
BrazilActive - Recruiting
Hospital Sao Lucas da PUCRS
Porto Alegre 3452925, Rio Grande do Sul 3451133 90610-000
BrazilActive - Recruiting
Ynova Pesquisa Clinica
Florianópolis 3463237, Santa Catarina 3450387 88020-210
BrazilActive - Recruiting
Unimed Sorocaba
Sorocaba 3447399, São Paulo 3448433 18065-100
BrazilActive - Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto 3448639, São Paulo 3448433 15090-000
BrazilActive - Recruiting
Hospital Alemao Oswaldo Cruz
São Paulo 3448439, 01323-903
BrazilActive - Recruiting
CHU Rennes
Rennes 2983990, Brittany Region 3030293 35033
FranceActive - Recruiting
Institut Curie
Paris, Ile De France 75005
FranceSite Not Available
Centre Hospitalier Intercommunal Toulon - CHITS
Toulon, Var 83055
FranceSite Not Available
Centre Hospitalier Intercommunal Toulon - CHITS
Toulon 2972328, Var 83055
FranceActive - Recruiting
Institut Curie
Paris 2988507, Île-de-France Region 3012874 75005
FranceActive - Recruiting
Centre Hospitalier de la Cote Basque
Bayonne, 64100
FranceActive - Recruiting
Clinique Belharra
Bayonne, 64100
FranceSite Not Available
Centre Hospitalier de la Cote Basque
Bayonne 3034475, 64100
FranceActive - Recruiting
Clinique Belharra
Bayonne 3034475, 64100
FranceActive - Recruiting
CHU Grenoble Alpes
Grenoble, 38330
FranceSite Not Available
CHU Grenoble Alpes
Grenoble 3014728, 38330
FranceActive - Recruiting
Montpellier Academic Hospital
Montpellier, 34295
FranceSite Not Available
Montpellier Academic Hospital
Montpellier 2992166, 34295
FranceActive - Recruiting
CHU Rennes
Rennes, 35033
FranceSite Not Available
Klinikum Kassel GmbH, Hauttumorzentrum
Kassel 2892518, Hesse 2905330 34125
GermanyActive - Recruiting
Klinikum Kassel GmbH, Hauttumorzentrum
Kassel, Hessen 34125
GermanySite Not Available
University Medicine Gottingen
Gottingen, Lower Saxony 37083
GermanySite Not Available
University Medicine Gottingen
Göttingen 2918632, Lower Saxony 2862926 37083
GermanyActive - Recruiting
University of Leipzig
Leipzig 2879139, Saxony 2842566 04103
GermanyActive - Recruiting
University Hospital RWTH Aachen
Aachen 3247449, 52074
GermanyActive - Recruiting
Catalan Instituye of Oncology Badalona
Badalona 3129028, Barcelona 08916
SpainActive - Recruiting
Hospital Universitario Marques
Santander, Cantabria 39008
SpainActive - Recruiting
Hospital Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital Valdecilla
Santander 3109718, Cantabria 3336898 39008
SpainActive - Recruiting
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas 35016
SpainSite Not Available
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria 2515270, Las Palmas 35016
SpainActive - Recruiting
Clinica Universidad de Navarra
Pamplona, Navarra 31008
SpainSite Not Available
Clinica Universidad de Navarra
Pamplona 3114472, Navarre 3115609 31008
SpainActive - Recruiting
Hospital Universitario Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Universitario HM Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario Clinico San Carlos
Madrid 3117735, 28040
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro
Madrid 3117735, 28050
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid 3117735, 28046
SpainActive - Recruiting
MD Anderson Cancer Center
Madrid 3117735, 28033
SpainActive - Recruiting
Hospital Virgen del Rocio
Seville, 41013
SpainSite Not Available
Hospital Virgen del Rocio
Seville 2510911, 41013
SpainActive - Recruiting
Consorci Hospital General Universitario de Valencia
Valencia, 46014
SpainActive - Recruiting
Hospital Clinico Universitario Valencia
Valencia, 46010
SpainSite Not Available
Consorci Hospital General Universitario de Valencia
Valencia 2509954, 46014
SpainActive - Recruiting
Hospital Clinico Universitario Valencia
Valencia 2509954, 46010
SpainActive - Recruiting
Hospital Clinico Lozano Blesa
Zaragoza, 50009
SpainSite Not Available
Hospital Clinico Lozano Blesa
Zaragoza 3104324, 50009
SpainActive - Recruiting
Florya Medical Park Hospital
Istanbul, 34295
TurkeySite Not Available
Florya Medical Park Hospital
Istanbul 745044, 34295
Turkey (Türkiye)Active - Recruiting
University of California Irvine
Orange, California 92868
United StatesSite Not Available
University of California Irvine
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
Orchard Healthcare Research Inc.
Skokie, Illinois 60077
United StatesSite Not Available
Orchard Healthcare Research Inc.
Skokie 4911600, Illinois 4896861 60077
United StatesActive - Recruiting
Prairie Lakes Healthcare System
Watertown, Massachusetts 57201
United StatesSite Not Available
Prairie Lakes Healthcare System
Watertown 4954611, Massachusetts 6254926 57201
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Detroit Clinical Research Center
Farmington Hills, Michigan 48334
United StatesSite Not Available
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
United StatesActive - Recruiting
Detroit Clinical Research Center
Farmington Hills 4992523, Michigan 5001836 48334
United StatesActive - Recruiting
Morristown Medical Center
Morristown, New Jersey 07960
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesSite Not Available
Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
United StatesActive - Recruiting
Providence Portland Medical Center
Portland, Oregon 97213
United StatesSite Not Available
Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213
United StatesActive - Recruiting
University Of Nebraska Medical Center
Portland 5746545, Oregon 5744337 97213
United StatesActive - Recruiting
Lifespan Cancer Institute
Providence, Rhode Island 02903
United StatesSite Not Available
Lifespan Cancer Institute
Providence 5224151, Rhode Island 5224323 02903
United StatesActive - Recruiting
Prairie Lakes Healthcare System
Watertown 5232741, South Dakota 5769223 57201
United StatesActive - Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United StatesSite Not Available
Tennessee Oncology
Nashville, Tennessee 37203
United StatesSite Not Available
University of Tennessee Medical Center
Knoxville 4634946, Tennessee 4662168 37920
United StatesActive - Recruiting
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
BRCC/Oncology & Hematology Associates of SW Virginia
Blacksburg 4747845, Virginia 6254928 24060
United StatesActive - Recruiting

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