Phase
Condition
N/ATreatment
S095024
S095018 Recommended Dose Expansion (RDE)
Cemiplimab
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)
Clinically significant infection, as assessed by the investigator
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
Buenos Aires 3435910,
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.
Santa Fe 3836277,
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
AustraliaSite Not Available
Border Medical Oncology Research Unit
Albury 2178174, 2640
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park, 5042
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park 2076918, 5042
AustraliaSite Not Available
Sunshine Hospital
St Albans, 3021
AustraliaSite Not Available
Sunshine Hospital
St Albans 8015209, 3021
AustraliaSite Not Available
Latrobe Regional Health
Traralgon, 3844
AustraliaSite Not Available
Latrobe Regional Health
Traralgon 2146108, 3844
AustraliaSite Not Available
Ordensklinikum Linz Elisabethinen
Linz, 4020
AustriaSite Not Available
Ordensklinikum Linz Elisabethinen
Linz 2772400, 4020
AustriaSite Not Available
Universitatsklinikum St. Poelten
Sankt Pölten 2766429, 3100
AustriaSite Not Available
Universitatsklinikum St. Poelten
St. Poelten, 3100
AustriaSite Not Available
Medical University of Vienna - Akh
Vienna 2761369, 1090
AustriaSite Not Available
Medical University of Vienna - Akh
Wien, 1090
AustriaSite Not Available
Jessa Ziekenhuis
Hasselt, 3500
BelgiumSite Not Available
Jessa Ziekenhuis
Hasselt 2796491, 3500
BelgiumSite Not Available
Uz Leuven Campus Gasthuisberg
Leuven, 3500
BelgiumSite Not Available
Uz Leuven Campus Gasthuisberg
Leuven 2792482, 3500
BelgiumSite Not Available
Hospital de Amor - Barretos
Barretos, 14784-400
BrazilSite Not Available
Hospital de Amor - Barretos
Barretos 3470451, 14784-400
BrazilSite Not Available
Supera Oncologia
Chapecó, 89812618
BrazilSite Not Available
Supera Oncologia
Chapecó 3466296, 89812618
BrazilSite Not Available
CIONC
Curitiba, 80810-050
BrazilSite Not Available
CIONC
Curitiba 3464975, 80810-050
BrazilSite Not Available
ONCOSITE
Ijuí, 98700-000
BrazilSite Not Available
ONCOSITE
Ijuí 3461444, 98700-000
BrazilSite Not Available
Liga Contra O Cancer - Natal
Natal, 59035-055
BrazilSite Not Available
Liga Contra O Cancer - Natal
Natal 3394023, 59035-055
BrazilSite Not Available
Hospital São Lucas Da Pucrs
Porto Alegre, 90619-900
BrazilSite Not Available
Santa Casa de Porto Alegre
Porto Alegre, 90020-090
BrazilActive - Recruiting
Hospital São Lucas Da Pucrs
Porto Alegre 3452925, 90619-900
BrazilSite Not Available
Santa Casa de Porto Alegre
Porto Alegre 3452925, 90020-090
BrazilSite Not Available
Oncoclinicas Rj
Rio De Janeiro, 22250-905
BrazilSite Not Available
Oncoclinicas Rj
Rio de Janeiro 3451190, 22250-905
BrazilSite Not Available
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
Hospital A C Camargo
São Paulo 3448439, 01509-010
BrazilSite Not Available
Hospital Albert Einstein
São Paulo 3448439, 05652-900
BrazilSite Not Available
Hospital São Camilo
São Paulo 3448439, 03102-002
BrazilSite Not Available
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo 3448439, 01246-000
BrazilSuspended
Oncoclinicas Sp
São Paulo 3448439, 04538-132
BrazilSite Not Available
Centre Georges Francois Leclerc
Dijon, 21079
FranceSite Not Available
Centre Georges Francois Leclerc
Dijon 3021372, 21079
FranceSite Not Available
Chu Grenoble Alpes
Grenoble, 38043
FranceSite Not Available
Chu Grenoble Alpes
Grenoble 3014728, 38043
FranceSite Not Available
Institut Paoli Calmette
Marseille, 13009
FranceSite Not Available
Institut Paoli Calmette
Marseille 2995469, 13009
FranceSite Not Available
Centre René Gauducheau/Inst de Cancér. de L'Ouest
Saint-Herblain, 44805
FranceSite Not Available
Centre René Gauducheau/Inst de Cancér. de L'Ouest
Saint-Herblain 2979590, 44805
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Institut Gustave Roussy
Villejuif 2968705, 94805
FranceSite Not Available
Hong Kong United Onology Centre
Hong Kong,
Hong KongActive - Recruiting
Prince of Wales Hospital
Hong Kong,
Hong KongActive - Recruiting
Queen Marry Hospital
Hong Kong,
Hong KongSite Not Available
Queen Mary Hospital
Hong Kong,
Hong KongActive - Recruiting
Sir Yue Kong Pao Centre for Cancer; Prince of Wales Hospital
Hong Kong,
Hong KongSite Not Available
Hong Kong United Onology Centre
Hong Kong 1819729,
Hong KongSite Not Available
Prince of Wales Hospital
Hong Kong 1819729,
Hong KongSite Not Available
Queen Mary Hospital
Hong Kong 1819729,
Hong KongSite Not Available
Farkasgyepu Tudogyogyintezet
Farkasgyepű, 8582
HungarySite Not Available
Farkasgyepu Tudogyogyintezet
Farkasgyepű 3053094, 8582
HungarySite Not Available
Bugat Pal Hospital
Gyöngyös, 3200
HungarySite Not Available
Bugat Pal Hospital
Gyöngyös 3052040, 3200
HungarySite Not Available
Pecsi Tudomanyegyetem, Klinikai Kozpont
Pécs, 7624
HungarySite Not Available
Pecsi Tudomanyegyetem, Klinikai Kozpont
Pécs 3046526, 7624
HungarySite Not Available
Centro Di Riferimento Oncologico
Aviano, 33081
ItalySite Not Available
Centro Di Riferimento Oncologico
Aviano 3182635, 33081
ItalySite Not Available
Inst. Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola, 47014
ItalySite Not Available
Inst. Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola 3173635, 47014
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda
Milan 6951411, 20162
ItalySite Not Available
Irccs Fondazione Istituto Nazionale Dei Tumori
Milan 6951411, 20133
ItalySite Not Available
Istituto Europeo Di Oncologia
Milan 6951411, 20141
ItalySite Not Available
A.O. Ospedale Niguarda Ca' Granda-Milano
Milano, 20162
ItalyActive - Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalySite Not Available
Irccs Fondazione Istituto Nazionale Dei Tumori
Milano, 20133
ItalyActive - Recruiting
Istituto Europeo Di Oncologia
Milano, 20141
ItalyActive - Recruiting
Ist. Nazionale Tumori Irccs Fondazione G Pascale
Napoli, 80131
ItalySite Not Available
Ist. Nazionale Tumori Irccs Fondazione G Pascale
Napoli 9031661, 80131
ItalySite Not Available
Azienda Ospedaliera S. Maria Della Misericordia
Perugia, 06132
ItalySite Not Available
Azienda Ospedaliera S. Maria Della Misericordia
Perugia 3171180, 06132
ItalySite Not Available
Istituto Nazionale Tumori Regina Elena
Roma, 00144
ItalySite Not Available
Istituto Nazionale Tumori Regina Elena
Roma 8957247, 00144
ItalySite Not Available
Istituto Clinico Humanitas I.R.C.C.S
Rozzano, 20089
ItalySite Not Available
Istituto Clinico Humanitas I.R.C.C.S
Rozzano 3168837, 20089
ItalySite Not Available
Pusan National University Hospital
Busan, 49241
Korea, Republic ofSite Not Available
Chungbuk National University Hospital
Cheongju-si, 28644
Korea, Republic ofSite Not Available
Gacheon University Gil Medical Center
Incheon, 21565
Korea, Republic ofSite Not Available
Korea University Guro Hospital
Seoul, 08308
Korea, Republic ofSite Not Available
Inst Oncologic "Prof Dr I Chiricuta" Cluj Napoca
Cluj-Napoca,
RomaniaSite Not Available
Inst Oncologic "Prof Dr I Chiricuta" Cluj Napoca
Cluj-Napoca 681290,
RomaniaSite Not Available
Centrul de Oncologie Sf Nectarie
Craiova,
RomaniaSite Not Available
Centrul de Oncologie Sf Nectarie
Craiova 680332,
RomaniaSite Not Available
Centrul de Radioterapie Amethyst
Otopeni,
RomaniaSite Not Available
Centrul de Radioterapie Amethyst
Otopeni 671590,
RomaniaSite Not Available
Ploiesti Municipal Hospital
Ploieşti,
RomaniaSite Not Available
Ploiesti Municipal Hospital
Ploieşti 670474,
RomaniaSite Not Available
Pusan National University Hospital
Busan 1838524, 49241
South KoreaSite Not Available
Chungbuk National University Hospital
Cheongju-si 1845604, 28644
South KoreaSite Not Available
Gacheon University Gil Medical Center
Incheon 1843564, 21565
South KoreaSite Not Available
Korea University Guro Hospital
Seoul 1835848, 08308
South KoreaSite Not Available
Val de Hebron Institute of Oncology (Vhio), University Hospital
Barcelona, 08035
SpainSite Not Available
Val de Hebron Institute of Oncology (Vhio), University Hospital
Barcelona 3128760, 08035
SpainActive - Recruiting
Vall D' Hebron Institute of Oncology (Vhio), University Hospital
Barcelona 3128760, 08035
SpainSite Not Available
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
SpainSite Not Available
Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase
Madrid, 28050
SpainActive - Recruiting
Clinica Universitaria de Navarra (Madrid)
Madrid 3117735, 28027
SpainSite Not Available
Hospital General Universitario Gregorio Marañón
Madrid 3117735, 28007
SpainSite Not Available
Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase
Madrid 3117735, 28050
SpainSite Not Available
Hospital Regional Universitario (Carlos Haya)
Málaga, 29010
SpainSite Not Available
Hospital Universitario Virgen de La Victoria
Málaga, 29010
SpainSite Not Available
Hospital Universitario Virgen de La Victoria
Málaga 2514256, 29010
SpainSite Not Available
Clinica Universitaria de Navarra (Pamplona
Pamplona, 31008
SpainSite Not Available
Clinica Universitaria de Navarra (Pamplona)
Pamplona, 31008
SpainSite Not Available
Clinica Universitaria de Navarra (Pamplona)
Pamplona 3114472, 31008
SpainSite Not Available
Hospital Universitario Virgen de La Victoria
Sevilla, 41013
SpainSite Not Available
Hospital Virgen Del Rocío
Sevilla, 41013
SpainSite Not Available
Hospital Virgen Del Rocío
Seville 2510911, 41013
SpainSite Not Available
Hospital Universitario Y Politecnico La Fe
Valencia, 46026
SpainSite Not Available
Hospital Universitario Y Politecnico La Fe
Valencia 2509954, 46026
SpainSite Not Available
National Taiwan University Hospital
Taipei, 100225
TaiwanSite Not Available
Tri-Service General Hospital
Taipei, 114202
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei 1668341, 100225
TaiwanSite Not Available
Tri-Service General Hospital
Taipei 1668341, 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
Imperial College London
London 2643743, SW7 2BX
United KingdomSuspended
The Royal Marsden in Chelsea
London 2643743, SW3 6JJ
United KingdomSite Not Available
The Royal Marsden in Sutton
London 2643743, SM2 5PT
United KingdomSite Not Available
The Christie Nhs Foundation Foundation Trust
Manchester, M20 4BX
United KingdomSite Not Available
The Christie Nhs Foundation Foundation Trust
Manchester 2643123, M20 4BX
United KingdomSite Not Available
Loma Linda University
Loma Linda, California 92354
United StatesSite Not Available
Loma Linda University
Loma Linda 5367696, California 5332921 92354
United StatesSite Not Available
University of Kansas Medical Center
Lawrence, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Lawrence 4274277, Kansas 4273857 66160
United StatesSite Not Available
Henry Ford Health
Detroit, Michigan 48202
United StatesSite Not Available
Henry Ford Health
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada 89119
United StatesSite Not Available
Comprehensive Cancer Center of Nevada
Las Vegas 5506956, Nevada 5509151 89119
United StatesSite Not Available
Gabrail Cancer Center
Canton, Ohio 44718
United StatesSite Not Available
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesSite Not Available
Gabrail Cancer Center
Canton 5149222, Ohio 5165418 44718
United StatesSite Not Available
Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
Virginia Cancer Specialists, P.C.
Fairfax, Virginia 22031
United StatesSite Not Available
Virginia Cancer Specialists, P.C.
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available

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