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
Institut Curie
Paris, Ile De France 75005
FranceActive - Recruiting
Centre Hospitalier Intercommunal Toulon - CHITS
Toulon, Var 83055
FranceActive - Recruiting
Centre Hospitalier de la Cote Basque
Bayonne, 64100
FranceActive - Recruiting
CHU Grenoble Alpes
Grenoble, 38330
FranceActive - Recruiting
Montpellier Academic Hospital
Montpellier, 34295
FranceActive - Recruiting
Hospital Universitario Marques
Santander, Cantabria 39008
SpainActive - Recruiting
Hospital Valdecilla
Santander, Cantabria 39008
SpainActive - Recruiting
Clinica Universidad de Navarra
Pamplona, Navarra 31008
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Virgen del Rocio
Seville, 41013
SpainActive - Recruiting
Consorci Hospital General Universitario de Valencia
Valencia, 46014
SpainActive - Recruiting
Hospital Clinico Lozano Blesa
Zaragoza, 50009
SpainActive - Recruiting
Orchard Healthcare Research Inc.
Skokie, Illinois 60077
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Detroit Clinical Research Center
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Morristown Medical Center
Morristown, New Jersey 07960
United StatesActive - Recruiting
Providence Portland Medical Center
Portland, Oregon 97213
United StatesActive - Recruiting
Lifespan Cancer Institute
Providence, Rhode Island 02903
United StatesActive - Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United StatesActive - Recruiting
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