Phase
Condition
N/ATreatment
Cemiplimab
S095029 RDE
S095018
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patient aged ≥ 18 years
Written informed consent
Histologically (squamous or non-squamous) or cytologically documented locallyadvanced NSCLC not eligible for surgical resection and/or definitive chemoradiation,or metastatic NSCLC
No prior systemic treatment for locally advanced or metastatic NSCLC
High tumor cell PD-L1 expression [Tumor Proportion Score (TPS) ≥50%] based ondocumented status as determined by an approved test
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Measurable disease as determined by RECIST v1.1
Exclusion
Exclusion Criteria:
Tumors harboring driver mutations/genetic aberrations for which targeted therapiesare approved as frontline treatment (e.g. EGFR mutation, ALK fusion oncogene, ROS1aberrations)
Prior immune checkpoint inhibitor therapy
Active brain metastases
Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis Cvirus (HCV) infection
Uncontrolled HIV infection. Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stableantiviral regimen) are allowed to enroll
Active, known or suspected autoimmune disease or immune deficiency
History of hypersensitivity reactions to any ingredient of the investigationalmedicinal product (IMP) and other monoclonal antibody (mAbs) and/or their excipients
History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-inducedpneumonitis, idiopathic pneumonitis or active pneumonitis ≥ grade 2
History of inflammatory bowel disease or colitis ≥ grade 2
History of hemophagocytic lymphohistiocytosis.
Systemic chronic steroid therapy (>10mg/d prednisone or equivalent)
Active infection, including infection requiring systemic antibiotic therapy
Pregnant or breast-feeding (lactating) women
Participants with a history of allogeneic organ transplantation (e.g., stem cell orsolid organ transplant)
Any medical condition that would in the investigator's judgement prevent theparticipant's participation in the clinical study
Study Design
Connect with a study center
Instituto Médico Especializado Alexander Fleming
Buenos Aires,
ArgentinaSite Not Available
Instituto Médico Especializado Alexander Fleming
Ciudad Autonoma de Buenos Aires,
ArgentinaSite Not Available
Sanatorio Parque S.A.
Santa Fe,
ArgentinaSite Not Available
Sanatorio Parque S.A.
Tucumán,
ArgentinaSite Not Available
Albury Wodonga Regional Cancer Centre; Border Medical Oncology Research Unit
Albury, 2640
AustraliaActive - Recruiting
Border Medical Oncology Research Unit
Albury, 2640
AustraliaActive - Recruiting
Flinders Medical Centre
Bedford Park, 5042
AustraliaActive - Recruiting
Sunshine Hospital
St Albans, 3021
AustraliaActive - Recruiting
Latrobe Regional Health
Traralgon, 3844
AustraliaActive - Recruiting
Ordensklinikum Linz Elisabethinen
Linz, 4020
AustriaActive - Recruiting
Universitatsklinikum St. Poelten
St. Poelten, 3100
AustriaActive - Recruiting
Medical University of Vienna - Akh
Wien, 1090
AustriaActive - Recruiting
Jessa Ziekenhuis
Hasselt, 3500
BelgiumSite Not Available
Uz Leuven Campus Gasthuisberg
Leuven, 3500
BelgiumSite Not Available
Hospital de Amor - Barretos
Barretos, 14784-400
BrazilSite Not Available
Supera Oncologia
Chapecó, 89812618
BrazilActive - Recruiting
CIONC
Curitiba, 80810-050
BrazilActive - Recruiting
ONCOSITE
Ijuí, 98700-000
BrazilSite Not Available
Liga Contra O Cancer - Natal
Natal, 59035-055
BrazilActive - Recruiting
Hospital São Lucas Da Pucrs
Porto Alegre, 90619-900
BrazilActive - Recruiting
Santa Casa de Porto Alegre
Porto Alegre, 90020-090
BrazilSite Not Available
Oncoclinicas Rj
Rio De Janeiro, 22250-905
BrazilActive - Recruiting
Hospital A C Camargo
São Paulo, 01509-010
BrazilSite Not Available
Hospital Albert Einstein
São Paulo, 05652-900
BrazilSite Not Available
Hospital São Camilo
São Paulo, 03102-002
BrazilActive - Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
BrazilSite Not Available
Oncoclinicas Sp
São Paulo, 04538-132
BrazilActive - Recruiting
Centre Georges Francois Leclerc
Dijon, 21079
FranceActive - Recruiting
Chu Grenoble Alpes
Grenoble, 38043
FranceSite Not Available
Institut Paoli Calmette
Marseille, 13009
FranceActive - Recruiting
Centre René Gauducheau/Inst de Cancér. de L'Ouest
Saint-Herblain, 44805
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Hong Kong United Onology Centre
Hong Kong,
Hong KongSite Not Available
Prince of Wales Hospital
Hong Kong,
Hong KongSite Not Available
Queen Marry Hospital
Hong Kong,
Hong KongSite Not Available
Queen Mary Hospital
Hong Kong,
Hong KongSite Not Available
Sir Yue Kong Pao Centre for Cancer; Prince of Wales Hospital
Hong Kong,
Hong KongSite Not Available
Farkasgyepu Tudogyogyintezet
Farkasgyepű, 8582
HungarySite Not Available
Bugat Pal Hospital
Gyöngyös, 3200
HungaryActive - Recruiting
Pecsi Tudomanyegyetem, Klinikai Kozpont
Pécs, 7624
HungarySite Not Available
Centro Di Riferimento Oncologico
Aviano, 33081
ItalyActive - Recruiting
Inst. Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola, 47014
ItalyActive - Recruiting
A.O. Ospedale Niguarda Ca' Granda-Milano
Milano, 20162
ItalyActive - Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalyActive - Recruiting
Irccs Fondazione Istituto Nazionale Dei Tumori
Milano, 20133
ItalySite Not Available
Istituto Europeo Di Oncologia
Milano, 20141
ItalyActive - Recruiting
Ist. Nazionale Tumori Irccs Fondazione G Pascale
Napoli, 80131
ItalyActive - Recruiting
Azienda Ospedaliera S. Maria Della Misericordia
Perugia, 06132
ItalyActive - Recruiting
Istituto Nazionale Tumori Regina Elena
Roma, 00144
ItalyActive - Recruiting
Istituto Clinico Humanitas I.R.C.C.S
Rozzano, 20089
ItalyActive - Recruiting
Pusan National University Hospital
Busan, 49241
Korea, Republic ofSuspended
Chungbuk National University Hospital
Cheongju-si, 28644
Korea, Republic ofSuspended
Gacheon University Gil Medical Center
Incheon, 21565
Korea, Republic ofSuspended
Korea University Guro Hospital
Seoul, 08308
Korea, Republic ofSuspended
Inst Oncologic "Prof Dr I Chiricuta" Cluj Napoca
Cluj-Napoca,
RomaniaSite Not Available
Centrul de Oncologie Sf Nectarie
Craiova,
RomaniaSite Not Available
Centrul de Radioterapie Amethyst
Otopeni,
RomaniaSite Not Available
Ploiesti Municipal Hospital
Ploieşti,
RomaniaSite Not Available
Val de Hebron Institute of Oncology (Vhio), University Hospital
Barcelona, 08035
SpainActive - Recruiting
Clinica Universitaria de Navarra (Madrid)
Madrid, 28027
SpainActive - Recruiting
Hospital General Universitario Gregorio
Madrid, 28007
SpainSite Not Available
Hospital General Universitario Gregorio Marañón
Madrid, 28007
SpainActive - Recruiting
Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase
Madrid, 28050
SpainActive - Recruiting
Hospital Regional Universitario (Carlos Haya)
Málaga, 29010
SpainSite Not Available
Hospital Universitario Virgen de La Victoria
Málaga, 29010
SpainActive - Recruiting
Clinica Universitaria de Navarra (Pamplona
Pamplona, 31008
SpainSite Not Available
Clinica Universitaria de Navarra (Pamplona)
Pamplona, 31008
SpainActive - Recruiting
Hospital Universitario Virgen de La Victoria
Sevilla, 41013
SpainSite Not Available
Hospital Virgen Del Rocío
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario Y Politecnico La Fe
Valencia, 46026
SpainActive - Recruiting
National Taiwan University Hospital
Taipei, 100225
TaiwanSite Not Available
Tri-Service General Hospital
Taipei, 114202
TaiwanSite Not Available
Imperial College London
London, SW7 2BX
United KingdomSuspended
The Royal Marsden in Chelsea
London, SW3 6JJ
United KingdomSite Not Available
The Royal Marsden in Sutton
London, SM2 5PT
United KingdomSite Not Available
The Christie Nhs Foundation Foundation Trust
Manchester, M20 4BX
United KingdomSite Not Available
Loma Linda University
Loma Linda, California 92354
United StatesSite Not Available
University of Kansas Medical Center
Lawrence, Kansas 66160
United StatesSite Not Available
Henry Ford Health
Detroit, Michigan 48202
United StatesSite Not Available
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada 89119
United StatesSite Not Available
Gabrail Cancer Center
Canton, Ohio 44718
United StatesActive - Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesActive - Recruiting
Virginia Cancer Specialists, P.C.
Fairfax, Virginia 22031
United StatesActive - Recruiting


Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.