比较REGN2810与铂类化疗药治疗晚期或转移性非小细胞肺癌

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试验详情

一、临床试验项目名称
比较REGN2810与铂类化疗药治疗晚期或转移性非小细胞肺癌

二、适应症
晚期或转移性非小细胞肺癌

三、试验介绍

主要目的：在肿瘤细胞程序性细胞死亡配体-1（PD-L1）表达≥50%的晚期或转移性非小细胞肺癌（NSCLC）患者的一线治疗中，比较REGN2810（Cemiplimab）治疗与铂类化疗药标准治疗的无进展生存期（PFS）。
关键次要目的：比较REGN2810与铂类化疗药的总生存期（OS）及客观缓解率（ORR）

研究中心所在省份及城市（具体启动情况以后期咨询为准）

研究中心	主要研究者
上海市肺科医院	周彩存，医学博士

序号	机构名称	主要研究者	国家	省（州）	城市
1	上海市肺科医院	周彩存	中国	上海	上海
2	天津市人民医院	王华庆	中国	天津	天津
3	临沂市肿瘤医院	石建华	中国	山东	临沂
4	北京肿瘤医院	赵军	中国	北京	北京
5	北京大学国际医院	梁军	中国	北京	北京
6	东南大学医学院附属江阴医院	茅卫东	中国	江苏	江阴
7	浙江省肿瘤医院	张沂平	中国	浙江	杭州
8	复旦大学附属上海市第五人民医院	揭志军	中国	上海	上海
9	北京协和医院	王孟昭	中国	北京	北京
10	哈尔滨医科大学附属肿瘤医院	陈公琰	中国	黑龙江	哈尔滨
11	中国人民解放军第八一医院	秦叔逵	中国	江苏	南京
12	Southern Medical Day Care	Clingan, Philip Rodney	Australia	New South Wales	Wollongong
13	St. Vincent's Hospital	Dowling, Anthony, J	Australia	Victoria	Fitzroy
14	Border Medical Oncology Research Unit - Albury Wodonga Regional Cancer Centre	Underhill, Craig	Australia	Nsw	Albury
15	Healthcare Institution 'Mogilev Regional Oncology Dispensary‘	Ivanova, Natalia, N	Belarus	Mogilev	Mogilev
16	Minsk City Clinical Oncology Dispensary	Prokharau, Aliaksandr	Belarus	Belarus	Minsk
17	Hospital Santa Izabel / Santa Casa de Misericordia da Bahia	Andrade, Livia Maria, Q	Brazil	Bahia	Salvador
18	Upco - Hcpa	Jobim de Azevedo, Sergio	Brazil	Porto Alegre	Santa Cecilia
19	Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)	Brust, Leandro	Brazil	Rio Grande do Sul	Lajeado
20	Instituto Joinvilense De Hematologia E Oncologia	Cicogna, Luis Fernando da, S	Brazil	Santa Catarina	Joinville
21	Associacao dos Functionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles (HED)	Marques dos Anjos, Gabriel	Brazil	Rio Grande Do Sul	Porto Alegre Rio Grande Do Sul
22	Instituto De Assistencia Medica Ao Servidor Publico Estadual - Iamspe - Hspe/Fmo	Gampel, Otavio	Brazil	Sp	S？o Paulo
23	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto	Girotto, Gustavo, C	Brazil	Sao Paulo	Sao Jose do Rio Preto
24	Centro Oncologico	Grabarz, Daniel	Brazil	Mogi das Cruzes	Mogi das Cruzes
25	Fundacao Pio XII-Hospital de Cancer de Barretos	Pinto, Gustavo, D	Brazil	Sao Paulo	Barretos
26	Hospital Sao Vicente de Paulo - Instituto do Cancer	Schlittler, Luis, A	Brazil	Rio Grande do Sul	Passo Fundo
27	Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner	Skare, Nils, G	Brazil	Parana	Curitiba
28	Unidade de Pesquisas Clinicas em Oncologia	Costa, Marcio Valerio	Brazil	RIO GRANDE DO SUL	Pelotas
29	Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)	Zukin, Mauro	Brazil	Rio de Janeiro	Rio de Janeiro
30	IMIP - Instituto de Medicina Integral Professor Fernando Figueira	do Prado Moura, Jose Fernando	Brazil	Pernambuco	Recife
31	Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Santa Rita	Santiago Escovar, Carlos Eugenio	Brazil	Rio Grande do Sul	Porto Alegre
32	Instituto Brasileiro de Controle do Cancer	Silva Melo Cruz, Felipe Jose	Brazil	Sao Paulo	Sao Paulo
33	MHAT Dobrich	Kasimova, Zyuhal	Bulgaria	Dobrich	Dobrich
34	MHAT Dr. Tota Venkova AD	Popova, Bonka	Bulgaria	Gabrovo	Gabrovo
35	Oncocentro	Acevedo Gaete, Alejandro Andres	Chile	valparaiso	Vina del Mar
36	Centro Internacional de Estudios Clinicos, CIEC	Aren Frontera, Osvaldo Rudy, s	Chile	Region Metropolitana	Santiago
37	Centro de Investigaciones Clinicas Vina del Mar Ltda.	Gonzalez Mella, Pablo, F	Chile	V Region Valparaiso	Vina del Mar
38	Instituto Clinico Oncologico del Sur (ICOS)	Yanez Ruiz, Eduardo, P	Chile	Temuco	Temuco
39	Clinica de la Costa LTDA	Bustillo Chams, Ivan	Colombia	Atlantico	Barranquilla
40	Administradora del Country S.A. - Clinica del Country	Cardona Zorrilla, Andres Felipe, F	Colombia	Cundinamarca	Bogota D.C.
41	Fundacion Oftalmologica de Santander-Clinica Ardila Lulle La FOSCAL	Rojas Diaz, Carlos Augusto	Colombia	Santander	Floridablanca
42	Dept of Pneumology	Havel, Libor	Czech Republic	Prague	Prague 4
43	Hospital Pelhrimov	Krizan, Karol	Czech Republic	Pelhrimov	Pelhrimov
44	Vseobecna Fakultni Nemocnice	Zemanova, Milada	Czech Republic	Prague	Praha 2
45	Nemocnice Novy Jicin	Chaudhary, Subhash, C	Czech Republic	Czech Republic	Novy Jicin
46	National Center for Tuberculosis and Lung Diseases of Georgia	Gogishvili, Shota	Georgia	Tbilisi	Tbilisi
47	High Technology Medical Center, University Clinic Tbilisi	Gogishvili, Miranda	Georgia	Tbilisi	Tbilisi
48	LTD Cancer Center of Adjara Autonomic Republic	Makharadze, Tamta	Georgia	Batumi	Batumi
49	Research Institute of clinical medicine	Melkadze, Tamar	Georgia	Tbilisi	Tbilisi
50	JSC Neo Medi	Shavdia, Mikheil	Georgia	Tbilisi	Tbilisi
51	LTD Medulla Chemotherapy and Immunotherapy Clinic	Zhvania, Mariam	Georgia	Tbilisi	Tbilisi
52	The Institute of Clinical Oncology	Gogishvili, Shota	Georgia	Tbilisi	Tbilisi
53	BioClinic Thessaloniki	Boukovinas, Ioannis, P	Greece	Thessaloniki	Thessaloniki
54	Metropolitan General Hospital	Georgoulias, Vassilios	Greece	Athens	Holargos
55	University General Hospital of Patras	Kalofonos, Haralabos	Greece	Achaia	Patras
56	General Hospital G.Papageorgiou, Aristotle University of Thessaloniki	Papandreou, Christos	Greece	Thessaloniki	Thessaloniki
57	Euromedica - General Clinic of Thessaloniki	Papazisis, Konstantinos	Greece	Thessaloniki	Thessaloniki
58	General Hospital of Kifissia Agioi Anargiroi	Samantas, Epaminondas	Greece	Athens	Athens
59	Sotiria General Hospital of Athens	Syrigos, Konstantinos, N	Greece	Athens	Athens
60	University General Hospital of Larissa	Kotsakis, Athanasios	Greece	Larissa	Larissa
61	Henry Dunant Hospital Center	Varthalitis, Ioannis-Isidoros	Greece	Athens	Athens
62	Iatriko Diavalkaniko Thessalonikis	Baka, Sofia	Greece	Thessaloniki	Pilaia
63	Szant Borbala Hospital	Bocskei, Csaba	Hungary	Komarom-Esztergom	Tatabanya
64	Pandy Kalman Hospital Member of Bekes County Central Hospital	Laczo, Ibolya	Hungary	Bekes	Gyula
65	Semmelweis Egyetem	Losonczy, Gyorgy	Hungary	Hungary	Budapest
66	Veszprem Megyei Tudogyogyintezet	Medgyasszay, Balazs	Hungary	Veszprem	Farkasgyepu
67	Debreceni Egyetem, I. sz. Belgyogyaszati Klinika	Szilasi, Maria	Hungary	Northern Great Plain	Debrecen
68	Zala Megyei Korhaz	Tehenes, Sandor	Hungary	Zalaegerszeg	Zalaegerszeg
69	Al-Khalidi Hospital and Medical Center	Abbasi, Salah	Jordan	Amman	Jabal Amman
70	King Abdullah University Hospital	Al Share, Osama	Jordan	Irbid	Irbid
71	Hammoud Hospital, University Medical Center	Farhat, Fadi	Lebanon	Sidon	Saida
72	Bellevue Medical Center	El Karak, Fadi	Lebanon	Beirut	Beirut
73	Middle East Institute of Health	Abi Gerges, Dany	Lebanon	Northern Metn	Bsalim
74	Ain Wazein Medical Village	Makarem, Jawad	Lebanon	Chouf/Aley	El Chouf
75	Hotel Dieu de France Hospital	Ghosn, Marwan	Lebanon	Beirut	Achrafieh
76	University Malaya Medical Centre (UMMC)	Gwo Fuang, Ho	Malaysia	Wilayah Persekutuan	Kuala Lumpur
77	Nilai Medical Centre	Rathnavelu, Kananathan	Malaysia	Negeri Sembilan	Nilai
78	Sarawak General Hospital	Voon, Pei Jye	Malaysia	Sarawak	Kuching
79	Universiti Kebangsaan Malaysia Medical Centre (UKMMC)	Ismail, Fuad	Malaysia	Kuala Lumpur	Kuala Lumpur
80	Hospital Pulau Pinang	Ai Lian, Tan	Malaysia	Pulau Pinang	Pulau Pinang
81	Mount Miriam Cancer Hospital	Raman, Rakesh	Malaysia	Penang	Tanjung Bungah
82	CIMAB S.A. de C. V.	Astorga, Alma, M	Mexico	Centro Torreon Coahuila	Centro Torreon Coahuila
83	Hospital Universitario De Monterrey-Doctor Jose Eleuterio Gonzalez	Lopez Chuken, Yamil Alonso	Mexico	Nuevo Leon	Monterey
84	ONCE Oncologia Especializada	Gonzalez Ramirez Benfield, Jose Rogelio	Mexico	Jalisco	Zapopan
85	Hospital Angeles Leon	Gonzalez Trujillo, Jose Luis	Mexico	Guanajuato	Leon
86	Phylasis Clinicas Research S. de R.L. de C.V.	Hernandez-Flores, Osvaldo	Mexico	Mexico	Cuautitlan Izcalli
87	Oaxaca Site Management Organization S.C.	Hernandez-Hernandez, Carlos, A	Mexico	Oaxaca	Oaxaca
88	Axis Heilsa S. de R. L. de C. V	Medina-Soto, Francisco, A	Mexico	Nuevo Leon	Monterrey
89	Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV	Murillo Ramirez, Emilio	Mexico	Jalisco	Zapopan
90	'Consultorio del Dr. Joaquín Gabriel Reinoso Toledo'	Reinoso-Toledo, Joaquin, G	Mexico	Nuevo Leon	Monterrey
91	Oncologico Potosino, S.C	Reyes Contreras, Jessica Gricelda	Mexico	San Luis Potosi	Col. Tequisquiapan
92	Centro estatal de cancerologia de chihuahua	Gonzalez Mendoza, Rene	Mexico	Chihuahua	Chihuahua
93	Cebu Doctors University Hospital	Alsay-Uy, Noemi, L	Philippines	Cebu	Cebu City
94	St. Luke's Medical Center (SLMC) - Pain Management Center	Galvez, Christina	Philippines	Metro Manila	Taguig City
95	Dr. Pablo O. Torre Memorial Hospital	Guancia, Adonis, A	Philippines	Negros Occidental	Bacolod City
96	Davao Doctors Hospital	Martinez-Lapus, Felycette Gay	Philippines	Davao Del Sur	Davao
97	Veterans Memorial Medical Center	Ong-Cornel, Annielyn Beryl, A	Philippines	Manila	Quezon City
98	St. Frances Cabrini Medical Center	Pulido, Rosalinda	Philippines	Batangas	Sto. Tomas
99	Manila Doctors Hospital	Samson-Fernando, Marie Cherry Lynn, C	Philippines	Metro Manila	Manila
100	Manila Doctors Hospital	Sandoval-Tan, Jennifer, B	Philippines	Metro Manila	Manila
101	Lung Center of the Philippines	Sy-Naval, Sullian	Philippines	Metro Manila	Quezon City
102	Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddzial Onkologiczny	Filipowska, Marzena	Poland	Malopolskie	Krakow
103	Wojewodzki Szpital Chorob Pluc im. dr Alojzego Pawelca	Gabrys, Jacek	Poland	Wodzislaw-Slaski	Wodzislaw-Slaski
104	Instytut Medyczny Santa Familia	Kalinka-Warzocha, Ewa	Poland	Lodz	Lodz
105	Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie	Kazarnowicz, Andrzej	Poland	Olsztyn	Olsztyn
106	Szpitale Pomorskie Sp. z o. o.	Danielewicz, Iwona	Poland	Pomorskie	Gdynia
107	Szpital Specjalistyczny w Prabutach Sp. z o.o.Oddzial Pulmonologii	Lowczak, Anna	Poland	Prabuty	Prabuty
108	MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie	Mruk, Andrzej, K	Poland	Rzeszow	Rzeszow
109	Zaglebiowskie Centrum Onkologii Szpital Specjalistyczny	Muszalski, Tomasz	Poland	Dabrowa Gornicza	Dabrowa Gornicza
110	Mazowiecki Szpital Specjalistyczny Sp. z o.o.	Papiewski, Wojciech	Poland	Radom	Radom
111	Medpolonia Sp. Z o.o.	Ramlau, Rodryg	Poland	Poznan	Poznan
112	Wojewodzki Szpital Zespolony im. L. Rydygiera	Sawrycki, Piotr	Poland	Torun	Torun
113	Wojskowy Instytut Medyczny	Duchnowska, Renata	Poland	Warsaw	Warszawa
114	Municipal Hospital Ploiesti	Doru Ghizdavescu, Gabriel	Romania	Prahova	Ploiesti
115	SC Radiotherapy Center Cluj SRL	Iacob, Ioan Catalin	Romania	Cluj	Jud Cluj
116	SC Oncolab SRL, Oncologie	Lungulescu, Dan, S	Romania	Jud Dolj	Dolj
117	S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala	Schenker, Michael	Romania	Dolj	Craiova
118	S.C. Oncocenter Oncologie Clinica SRL	Scheusan, Roxana-Ioana	Romania	jud Timis	Timisoara
119	Sverdlovsk Regional Oncology Dispensary	Bentsion, Dmitriy, L	Russia	Russia	Yekaterinburg
120	Arkhangelsk Clinical Oncological Dispensary	Nechaeva, Marina, P	Russia	Arkhangelsk	Arkhangelsk
121	EVIMED Limited Liability Company	Gladkov, Oleg, A	Russia	Chelyabinsk	Chelyabinsk
122	Tomsk National Research Medical Centre of the Russian Academy of Sciences	Goldberg, Viktor, E	Russia	Tomsk	Tomsk
123	FSBSI Russian Cancer Research Center n.a. N.N.Blokhin	Laktionov, Konstantin	Russia	Moscow	Moscow
124	Tomsk Regional Oncology Dispensary	Kirillova, Natalia, A	Russia	Tomsk Region	Tomsk
125	State Budgetary Healthcare Institution of Kemerovo Region, Regional Clinical Oncology Dispensary	Vyalova, Ksenia	Russia	Kemerovo Region	Kemerovo
126	Medical University REAVIZ	Kopp, Mikhail, V	Russia	Samara	Samara
127	Belgorod Regional Oncology Dispensary	Kuzina, Ludmila, I	Russia	Belgorod	Belgorod
128	Kursk Regional Oncology Dispensary	Lifirenko, Igor, D	Russia	Russia	Kursk
129	FGBU NMIC of Oncology n.a. N.N. Petrov of Minzdrav of Russia	Protsenko, Svetlana, A	Russia	Pesochny	Saint-Petersburg
130	State Budgetary Healthcare Institution of Kaluga Region ？Kaluga Regional Clinical Oncology Dispensary？	Rozhkova, Irina, A	Russia	Kaluga	Kaluga
131	State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Bashkortostan (GAUZ RKOD MINZDRAVARB)	Sakaeva, Dina, D	Russia	Republic Bashkortost	Ufa
132	State Budgetary Healthcare Institution of the Republic of Mordovia	Skopin, Pavel	Russia	Saransk	Saransk
133	Moscow City Oncology Hospital 62	Stroyakovskiy, Daniil, L	Russia	Moscow	Moscow
134	SHI Oncology Dispensary #2 of Krasnodar Region	Udovitsa, Dmitriy, P	Russia	Krasnodar Region	Sochi
135	Private medical institution Euromedservice	Penkov, Konstantin	Russia	Saint Petersburg	Pushkin
136	Saint-Petersburg State Budgetary Healthcare Institution - City Clinical Oncology Dispensary	Karaseva, Nina, A	Russia	Saint-Peterburg	Saint-Peterburg
137	Federal State Budgetary Institution	Mosina, Nina	Russia	Saint-Peterburg	Saint-Petersburg
138	Omsk Region Clinical Oncology Dispensary	Dvorkin, Mikhail	Russia	Omsk Region	Omsk
139	State Budgetary Healthcare Institution Leningrad Regional Oncology Dispensary	Kostorov, Vladimir	Russia	Leningrad Region	Vsevolozhskiy District
140	Republican Clinical Oncology Dispensary	Mukhametshina, Guzel, Z	Russia	Tatarstan Republic	Kazan
141	JSC Medsi group	Ledin, Evgeny, V	Russia	Moscow	Moscow
142	SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary	Vladimirov, Vladimir, I	Russia	Stavropol region	Pyatigorsk
143	Althaia	Catot Tort, Silvia	Spain	Barcelona	Manresa
144	Clinica Universidad de navarra	Gil Bazo, Ignacio	Spain	Navarra	Pamplona
145	Hospital Clinic de Barcelona	Reguart Aransay, Noemi	Spain	Barcelona	Barcelona
146	Taipei Municipal Wanfang Hospital	Chang, Chia-Lun	中国	Taipei	Taipei
147	Taichung Veterans General Hospital	Chang, Gee-Chen	中国	Taiwan	Taichung
148	Taipei Veterans General Hospital	Chen, Yuh-Min	中国	Taiwan (R.O.C)	Taipei
149	Kaohsiung Medical University Hospital	Chong, Inn-Wen	中国	Kaohsiung	Kaohsiung
150	China Medical University Hospital	Hsia, Te-Chun	中国	Taiwan (R.O.C)	Taichung City
151	Taipei Tzu Chi General Hospital	Huang, Chun-Yao	中国	Taiwan	New Taipei City
152	Taipei Medical University Shuang Ho Hospital	Lee, Kang-Yun	中国	Taiwan	New Taipei
153	Changhua Christian Hospital	Li, Chien-Te	中国	Changhua County	Changhua City
154	Buddhist Tzu Chi General Hospital	Wang, Tso-Fu	中国	Hualien County	Hualien
155	E-DA Hospital	Wei, Yu Feng	中国	Kaohsiung	Kaohsiung City
156	Tri-Service General Hospital	Ho, Ching-Liang	中国	Taipei	Taipei City
157	Udonthani Cancer Hospital	Butthongkomvong, Kritiya	Thailand	Udonthani	Amphur Muang
158	Naresuan University Hospital	Jitpewngarm, Wittawat	Thailand	Phitsanulok Province	Phitsanulok province
159	Lopburi Cancer Hospital	Pornpraserthsuk, Piti	Thailand	Muang	Muang
160	Clinical Research center Phramongkutklao Hospital	Saichamchan, Siriwimon	Thailand	Bangkok	Bangkok
161	Lampang Cancer Hospital	Sorrarittichingchai, Sirikul	Thailand	Lampang	A. Mueang
162	Chulalongkorn University	Sriuranpong, Virote	Thailand	Bangkok	Bangkok
163	Prince Of Songkla Hospital, Prince Of Songkhla University	Sunpaweravong, Patrapim	Thailand	Songkhla	Hat-Yai
164	Chiangrai Prachanukroh Hospital	Tharavichitkul, Ekkapong	Thailand	Chiang Rai	Muang
165	Khon Kaen Hospital	Thongthieang, Luangyot	Thailand	Muang	Muang
166	Rajavithi Hospital	Tienchaiananda, Piyawan	Thailand	Bangkok	Ratchathewi
167	Baskent University Faculty of Medicine Ankara Hospital	Altundag, Ozden	Turkey	Ankara	Ankara
168	Saglik Bilimleri Universitesi, Dr.Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi	Guclu, Salih, Z	Turkey	Izmir	Izmir
169	Istanbul University Cerrahpasa Medical Faculty	Ozguroglu, Mustafa	Turkey	Istambul	Istanbul
170	Cukurova Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali Tibbi Onkoloji Bilim Dali	Paydas, Semra	Turkey	Adana	Adana
171	Ankara Universitesi Tip Fakultesi Cebeci Hastanesi	Demirkazik, Ahmet	Turkey	Ankara	Ankara
172	Dokuz Eylul University Oncology Institute	Somali, Isil	Turkey	Izmir	Izmir
173	Ondokuz Mayis Universitesi Tip Fakultesi	Yilmaz, Bahiddin	Turkey	Samsun	Samsun
174	Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi	Kilickap, Saadettin	Turkey	Ankara	Ankara
175	T.C. Saglik Bakanligi Ankara Ataturk Egitim Ve Arastirma Hastanesi - Hastaliklari (Dahiliye) Klinigi	Yalcin, Bulent	Turkey	Ankara	Ankara
176	Baskent University Adana Education and Training Hospitalniversitaetsspital Zurich	Sezer, Ahmet	Turkey	Adana	Adana
177	Ege Universitesi Tip Fakultesi lc Hastaliklari Anabilim Dali	Goksel, Tuncay	Turkey	Izmir	Izmir
178	Diskapi Yildirim Beyazit Training and Research Hospital	Kurt, Bahar	Turkey	Ankara	Ankara
179	Istanbul Medeniyet Universitesi Tip Fakultesi-Istanbul Medeniyet Universitesi Dumlupinar	Gumus, Mahmut	Turkey	Istanbul	Istanbul
180	Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi	Turk, Haci Mehmet	Turkey	Istanbul	Istanbul
181	Trakya Universitesi Saglik Arastirma ve Uygulama Hastanesi	Cicin, Irfan	Turkey	Edirne	Edirne
182	Yedikule Chest Disease Hospital	Kiyik, Murat	Turkey	Zeytinburnu	Zeytinburnu
183	Dnepropetrovsk State Medical Academy	Bondarenko, Igor, N	Ukraine	Ukraine	Dnepropetrovsk
184	Kyiv Clinical Regional Hospital	Golovko, Yuriy	Ukraine	Kiev	Kiev
185	Zaporozhye regional clinical oncology center	Kolesnik, Oleksii	Ukraine	Kirovogradskaya Obla	Zaporozhye
186	National Cancer Institute	Ostapenko, Yuriy	Ukraine	Kiev	Kiev
187	Ivano-Frankivsk National Medical University	Kryzhanivska, Anna	Ukraine	Ivano-Frankivsk	Ivano-Frankivsk
188	Municipal Non-Profit Enterprise Regional Oncology Centre	Kobziev, Oleg	Ukraine	Kharkiv	Kharkiv
189	Private Enterprise of Private Manufacturing Company Acinus, Medical and Diagnostic Center	Ursol, Grygorii, N	Ukraine	Kirovograd	Kirovograd
190	Kherson Regional Oncology Dispensary	Sokur, Irina	Ukraine	Kherson	Kherson
191	Kherson Regional Oncology Dispensary	Sokur, Irina	Ukraine	Kherson	Kherson
192	Transkarpathian Regional Oncology Clinic	Rusyn, Andriy, V	Ukraine	Transkarpathia	Uzhgorod
193	Vinnitsa Regional Clinical Oncological Center	Kostiuk, Oleksandr	Ukraine	Vinnitsya	Vinnitsya
194	Prognosis Optima-LLC	Kulyaba, Yaroslav, M	Ukraine	Kyiv	Kyiv
195	NRI of Neurosurgery of AMS of Ukraine n.a A.P. Romodanov	Leshchenko, Iurii	Ukraine	Zaporizhzhia	Zaporizhzhia
196	徐州中心医院	刘勇	中国	江苏	徐州
197	广东药科大学附属第一医院	王希成	中国	广东	广州
198	广州医科大学附属肿瘤医院	李卫东	中国	广东	广州
199	云南省肿瘤医院	李高峰	中国	云南	昆明
200	河南省肿瘤医院	赵艳秋	中国	河南	郑州
201	天津医科大学总医院	钟殿胜	中国	天津	天津
202	苏州大学第一附属医院	黄建安	中国	江苏	苏州
203	福建省肿瘤医院	庄武	中国	福建	福州
204	福州肺科医院	陈群	中国	福建	福州
205	广西医科大学附属肿瘤医院	于起涛	中国	广西	南宁
206	广东医科大学附属医院	李姝珺	中国	广东	广州
207	杭州市第一人民医院	马胜林	中国	浙江	杭州
208	南京市第一医院	谷伟	中国	江苏	南京
209	首都医科大学附属北京胸科医院	张树才	中国	北京	北京
210	蚌埠医学院第一附属医院	毕明宏	中国	安徽	蚌埠
211	安徽省肿瘤医院	张志红	中国	安徽	合肥

1	年龄≥18岁的男性和女性。
2	有组织学或细胞学证明的IIIB期或IIIC期疾病且不适于接受确定性合并放化疗的鳞状或非鳞状NSCLC患者，或有IV期疾病且先前未接受过针对复发性或转移性NSCLC的全身治疗的患者。a.接受辅助或新辅助双重铂类化疗药治疗（术后和/或放疗）并且在完成治疗6个月以后出现复发性或转移性疾病的患者符合研究资格。a.接受辅助或新辅助双重铂类化疗药治疗（术后和/或放疗）并且在完成治疗6个月以后出现复发性或转移性疾病的患者符合研究资格。
3	有取自转移/复发部位的福尔马林固定的肿瘤组织（存档或新采集的），未经辐照。a.如果病灶仍处于原发部位以及其他无法进入（即，大脑）、无法使用（如，骨骼）或活检的转移部位会将使患者处于不当风险时，可从原发部位采集组织。b.所用的存档活检必须不足5个月
4	中心实验室通过IHC测定的肿瘤细胞PD-L1表达≥50%。
5	按照RECIST 1.1标准，通过计算机断层扫描（CT）或磁共振成像（MRI）有至少1个放射影像可测量病灶（参见附件2）。如有证据（放射影像）表明该部位的疾病进展，则靶病灶可能位于先前辐照的区域。
6	ECOG体能状态≤1。
7	预期寿命至少为3个月。
8	有适当的器官和骨髓功能：a.血红蛋白≥ 9.0 g/dL。b.中性粒细胞绝对计数 ≥ 1.5 x 109/L。c.血小板计数≥100,000/mm3。d.肾小球滤过率（GFR）>30 mL/min/1.73m2。e.总胆红素≤正常上限（ULN）1.5倍（如有肝转移，则应≤3×ULN），除非患者临床确诊为Gilbert-Meulengracht综合征）。f.天冬氨酸氨基转移酶（AST）和丙氨酸氨基转移酶（ALT）≤3 × ULN，或者是AST和ALT≤5 ×ULN（如有肝转移）。g.碱性磷酸酶≤2.5 × ULN（如有肝转移，则应≤5.0×ULN）。h.不符合Hy法则标准（ALT> 3×ULN，胆红素> 2×ULN）。
9	愿意并且能够遵守诊所访视和研究相关规程。
10	签署知情同意书。
11	能够理解并完成相关调查问卷。

1	从未吸烟，定义为终生吸烟量≤100支香烟。
2	活动性或未经治疗的脑转移或脊髓压迫。如果中枢神经系统（CNS）转移得到充分治疗并且患者在随机化前至少2周时的神经状况恢复至基线（与CNS治疗相关的残留体征或症状除外），则患者符合研究资格。患者必须停止（免疫抑制剂量的）皮质类固醇治疗。
3	肿瘤患者检测为EGFR基因突变阳性、ALK基因易位或ROS1融合。所有患者应有经中心实验室证实的EGFR突变、ALK基因易位或ROS1融合的肿瘤评价。
4	在随机化之前1年内有脑炎、脑膜炎或不受控的癫痫发作。
5	在随机化之前1年内有脑炎、脑膜炎或不受控的癫痫发作。
6	患者在最近2年内有已知或疑似活动性自身免疫性疾病，需要全身治疗。仅需要激素替代治疗的白癜风、I型糖尿病和甲状腺功能减退症（包括自身免疫性甲状腺炎引起的甲状腺功能减退症）患者可以接受随机分配。
7	随机化之前14天内需要皮质类固醇治疗（泼尼松龙，>10 mg/天或当量）的患者。只要不是用于免疫抑制目的，则可以接受使用生理替代剂量（即便泼尼松龙>10 mg/天或当量）。只要不是用于治疗自身免疫性疾病，则可以接受使用吸入或外用类固醇。
8	患有处于进展状态或需要治疗的另一种恶性肿瘤，但有潜在治愈性治疗的非黑色素瘤性皮肤癌或原位宫颈癌或已经治疗的任何其他肿瘤除外，但条件是患者应在随机化前至少2年达到完全缓解并且在研究期间不需要额外的治疗。
9	乙型肝炎或丙型肝炎免疫缺陷病毒无法控制的感染；或免疫缺陷诊断：a.允许感染（血清乙型肝炎病毒DNA PCR低于检测限且接受乙型肝炎抗病毒治疗）得到控制的乙型肝炎患者（HepBsAg+）。b.允许感染（在自发或抗HCV治疗前期成功缓解的情况下均无法经PCR检出HCV RNA）得到控制的丙型肝炎病毒抗体阳性（HCV Ab+）患者。c.允许感染（在自发或稳定抗病毒方案情况下无法检出病毒载量且CD4计数大于350）得到控制的HIV患者
10	随机化之前14天内有需要全身治疗的活动性感染
11	先前接受过抗PD-1或抗PD-L1治疗。允许先前暴露于其他免疫调节剂或疫苗（如抗细胞毒性T淋巴细胞相关抗原4（CTLA-4）抗体），但抗体末次给药应在研究药物首次给药之前至少3个月。
12	存在免疫调节剂（包括但不仅限于抗PD1/PD-L1 mAb，抗CTLA4 mAb和磷脂酰肌醇3-激酶[PI3-K]-δ抑制剂）治疗相关的免疫介导不良事件，并且在研究治疗开始前至少3个月未能恢复至基线。如果患者先前发生过于既往PD-1/PD-L1通路阻断剂治疗相关的免疫介导不良事件，严重程度为3或4级和/或需要停药，则无论发生时间，均不得接受Cemiplimab治疗。
13	在筛选前30天内或本研究用药物的5个半衰期内（以时间较长者为准），接受过研究用药物或器械。
14	在计划开始给予研究药物前30天内接种了活疫苗。
15	在首次给药前4周内有过大手术或重大创伤性损伤。
16	可归因于抗体治疗的过敏或急性超敏反应。
17	已知患有精神病或药物滥用障碍，将会干扰参与研究要求（包括目前正在使用的任何非法药物。
18	妊娠期或哺乳期女性。
19	性活跃男性或有生育能力的女性而不愿意在首次给药之前、研究期间和末次给药后至少6个月内采取高效的避孕措施。高效避孕措施包括：可在筛选前至少2个月经周期，使用可抑制排卵的高效避孕措施，包括稳定使用口服避孕药或其他激素避孕药（如阴道内、透皮或仅含孕激素的避孕方法）；宫内节育器；宫内激素释放系统；双侧输卵管结扎；输精管结扎和禁欲*。可证明输精管结扎的男性无需进行避孕。绝经后妇女必须闭经至少12个月，否则将属于有生育潜力。可证明子宫切除术或输卵管结扎的女性无需接受妊娠试验和避孕。*绝对禁欲：当这符合患者的首选和日常生活方式时。（定期禁欲[例如日历法、排卵法、症状体温法、排卵后避孕法]、在试验期间宣布禁欲以及体外排精法是不可接受的避孕方法）。
20	被司法机关或行政机关指令监禁的患者将被排除在本研究之外。
21	既往接受过Idelalisib治疗
22	临床中心研究小组和/或其直系亲属的成员，除非申办方事先批准
23	器官移植受者
24	活动性或潜伏性结核病。基于当地指导原则，应通过纯化蛋白衍生物（PPD）/QuantiFERON检测排除高危个体（根据研究者的判断）的潜伏性疾病

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