Phase
Condition
Non-small Cell Lung Cancer
Treatment
Cisplatin
Pembrolizumab SC
Paclitaxel
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has pathologically (histologically or cytologically) confirmed diagnosis of squamousor nonsquamous non-small cell lung cancer (NSCLC)
Has Stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer 8th Edition) squamous or nonsquamous NSCLC
Has confirmation that epidermal growth factor receptor (EGFR), Anaplastic lymphomakinase (ALK), or ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1)-directedtherapy is not indicated in nonsquamous NSCLC as well as mixed nonsquamous/squamousNSCLC. Participants with purely squamous NSCLC do not require testing
Has not received prior systemic treatment for their metastatic NSCLC. Participantswho received adjuvant or neoadjuvant therapy are eligible if theadjuvant/neoadjuvant therapy was completed at least 12 months prior to thedevelopment of metastatic disease
Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1
Male participants are eligible to participate if they agree to use contraception asper protocol unless confirmed to be azoospermic
A female participant is eligible to participate if she is not pregnant orbreastfeeding, and at least one of the following conditions applies: is not a womanof childbearing potential (WOCBP) or is a WOCBP who agrees of using a contraceptivemethod per protocol
Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
Submit an archival tumor tissue sample or newly obtained core or incisional biopsyof a tumor lesion not previously irradiated for PD-L1 status determination prior torandomization
Has adequate organ function
Exclusion
Exclusion Criteria:
Has a known additional malignancy that is progressing or has required activetreatment within the past 3 years
Has known central nervous system (ie, brain and/or spinal cord) metastases and/orcarcinomatous meningitis. Participants with treated brain metastases may participateonly if they satisfy all of the following: a) Have no evidence of new or enlargingbrain metastases confirmed by post-treatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and b) Are neurologically stable withoutthe need for steroids for at least 14 days before first dose of trial treatment asper local site assessment
Has severe hypersensitivity to study intervention and/or any of its excipients
Has an active autoimmune disease that has required systemic treatment in past 2years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection and/or HepatitisB infection or known active Hepatitis C infection
Has a known psychiatric or substance abuse disorder that would interfere with theparticipant's ability to cooperate with the requirements of the study
Has symptomatic ascites or pleural effusion. A participant who is clinically stableafter treatment for these conditions is eligible
Before the first dose of study intervention: a) Has received prior systemiccytotoxic chemotherapy for metastatic NSCLC b) Has received antineoplasticbiological therapy for metastatic NSCLC c) Has had major surgery (<3 weeks prior tofirst dose) d) Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmedcell death ligand 2 (anti-PD-L2) agent or with an agent directed to anotherstimulatory or coinhibitory T-cell receptor
Received radiation therapy to the lung that is >30 Gray within 6 months of the firstdose of study intervention
Is expected to require any other form of antineoplastic therapy while on study
For participants with nonsquamous histology: Is unable to interrupt aspirin or otherNon-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3g/day, for a 5-day period
For participants with nonsquamous histology: Is unable or unwilling to take folicacid or vitamin B12 supplementation
Has received prior radiotherapy within 2 weeks of start of study intervention orhave had a history of radiation pneumonitis. Participants must have recovered fromall radiation-related toxicities and not require corticosteroids. A 1-week washoutis permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
Has received a live or live attenuated vaccine within 30 days prior to the firstdose of study intervention
Is currently participating in or has participated in a study of an investigationalagent or has used an investigational device within 4 weeks prior to the first doseof study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapyor any other form of immunosuppressive therapy within 7 days prior the first dose ofstudy intervention
Has had an allogenic tissue/solid organ transplant
Study Design
Connect with a study center
HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307)
Cachoeiro de Itapemirim, Espirito Santo 29308-065
BrazilSite Not Available
Hospital Sao Vicente de Paulo ( Site 0311)
Passo Fundo, Rio Grande Do Sul 99010-080
BrazilSite Not Available
Instituto Joinvilense de Hematologia e Oncologia ( Site 0308)
Joinville, Santa Catarina 89201260
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305)
Sao Jose do Rio Preto, Sao Paulo 15090-000
BrazilSite Not Available
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304)
São Paulo, Sao Paulo 04014-002
BrazilSite Not Available
Nouvel Hôpital Civil (NHC) ( Site 1018)
Strasbourg, Bas-Rhin 67091
FranceSite Not Available
CHU Limoges CHU Dupuytren ( Site 1011)
Limoges, Haute-Vienne 87042
FranceSite Not Available
Hôpital Foch ( Site 1019)
Suresnes, Hauts-de-Seine 92150
FranceSite Not Available
Institut Regional du Cancer de Montpellier - ICM ( Site 1003)
Montpellier, Herault 34298
FranceSite Not Available
Centre Hospitalier Sud Réunion ( Site 1020)
Saint-Pierre, La Reunion 97448
FranceSite Not Available
Hopital Guillaume & Rene Laennec ( Site 1007)
Saint-Herblain, Loire-Atlantique 44800
FranceSite Not Available
Centre Hospitalier de Pau ( Site 1016)
Pau, Pyrenees-Atlantiques 64000
FranceSite Not Available
CHU de Rouen ( Site 1013)
Rouen, Seine-Maritime 76031
FranceSite Not Available
Hopital Cochin ( Site 1002)
Paris, 75014
FranceSite Not Available
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602)
Guatemala, 01010
GuatemalaSite Not Available
Clinica Privada Dr. Rixci Ramirez ( Site 0601)
Guatemala, 01010
GuatemalaSite Not Available
Grupo Angeles SA ( Site 0604)
Guatemala, 01015
GuatemalaSite Not Available
INTERVASC ( Site 0605)
Guatemala, 01010
GuatemalaSite Not Available
Centro Regional de Sub Especialidades Médicas SA ( Site 0600)
Quetzaltenango, 09001
GuatemalaSite Not Available
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106)
Kecskemét, Bacs-Kiskun 6000
HungarySite Not Available
Petz Aladar Megyei Oktato Korhaz ( Site 1110)
Gyor, Gyor-Moson-Sopron 9023
HungarySite Not Available
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103)
Szolnok, Jasz-Nagykun-Szolnok 5000
HungarySite Not Available
Tudogyogyintezet Torokbalint ( Site 1105)
Torokbalint, Pest 2045
HungarySite Not Available
Veszprem Megyei Tudogyogyintezet ( Site 1108)
Farkasgyepu, Veszprem 8582
HungarySite Not Available
Zala Megyei Szent Rafael Korhaz ( Site 1111)
Zalagerszeg, Zalaegerszeg 8900
HungarySite Not Available
Orszagos Koranyi Pulmonologiai Intezet ( Site 1104)
Budapest, 1121
HungarySite Not Available
Semmelweis University-Pulmonológiai Klinika ( Site 1114)
Budapest, 1083
HungarySite Not Available
Fujita Health University Hospital ( Site 3007)
Toyoake, Aichi 4701192
JapanSite Not Available
Ehime University Hospital ( Site 3005)
Toon, Ehime 791-0295
JapanSite Not Available
Kurume University Hospital ( Site 3006)
Kurume, Fukuoka 830-0011
JapanSite Not Available
National Hospital Organization Hokkaido Cancer Center ( Site 3014)
Sapporo, Hokkaido 003-0804
JapanSite Not Available
Kanazawa University Hospital ( Site 3004)
Kanazawa, Ishikawa 920-8641
JapanSite Not Available
Kanagawa Cardiovascular and Respiratory Center ( Site 3003)
Yokohama, Kanagawa 236-0051
JapanSite Not Available
Miyagi Cancer Center ( Site 3000)
Natori, Miyagi 981-1293
JapanSite Not Available
Sendai Kousei Hospital ( Site 3015)
Sendai, Miyagi 980-0873
JapanSite Not Available
Kurashiki Central Hospital ( Site 3013)
Kurashiki, Okayama 710-8602
JapanSite Not Available
Kansai Medical University Hospital ( Site 3016)
Hirakata, Osaka 573-1191
JapanSite Not Available
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3009)
Sakai, Osaka
JapanSite Not Available
Osaka Medical and Pharmaceutical University Hospital ( Site 3017)
Takatsuki, Osaka 569-8686
JapanSite Not Available
Chiba University Hospital ( Site 3008)
Chiba, 260-8677
JapanSite Not Available
National Hospital Organization Kyushu Cancer Center ( Site 3002)
Fukuoka, 811-1395
JapanSite Not Available
National Hospital Organization Kyushu Medical Center ( Site 3001)
Fukuoka, 810-8563
JapanSite Not Available
Okayama University Hospital ( Site 3012)
Okayama, 7008558
JapanSite Not Available
Osaka International Cancer Institute ( Site 3018)
Osaka, 541-8567
JapanSite Not Available
Tokushima University Hospital ( Site 3019)
Tokushima, 770-8503
JapanSite Not Available
Juntendo University Hospital ( Site 3011)
Tokyo, 113-8431
JapanSite Not Available
Showa University Hospital ( Site 3010)
Tokyo, 142-8666
JapanSite Not Available
Chungnam National University Hospital ( Site 2002)
Daejeon, Chungnam 35015
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2000)
Hwasun, Jeonranamdo 58128
Korea, Republic ofSite Not Available
Korea University Guro Hospital ( Site 2003)
Seoul, 08308
Korea, Republic ofSite Not Available
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0704)
Arequipa, Ariqipa 04001
PeruSite Not Available
Clínica Peruano-Americana de Trujillo ( Site 0701)
Trujillo, La Libertad 13007
PeruSite Not Available
Oncosalud ( Site 0706)
Lima, Muni Metro De Lima 15036
PeruSite Not Available
Clinica Internacional Sede San Borja ( Site 0705)
Lima, 15036
PeruSite Not Available
Hospital Nacional Cayetano Heredia ( Site 0700)
Lima, 15102
PeruSite Not Available
Instituto Nacional de Enfermedades Neoplasicas ( Site 0703)
Lima, 15038
PeruSite Not Available
Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1201)
Bydgoszcz, Kujawsko-pomorskie 85-796
PolandSite Not Available
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1206)
Siedlce, Mazowieckie 08-110
PolandSite Not Available
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warszawa, Mazowieckie 02-781
PolandSite Not Available
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1205)
Bystra, Slaskie 43-360
PolandSite Not Available
Przychodnia Lekarska KOMED ( Site 1202)
Konin, Wielkopolskie 62-500
PolandSite Not Available
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1200)
Koszalin, Zachodniopomorskie 75-581
PolandSite Not Available
Cardiomed SRL Cluj-Napoca ( Site 1313)
Cluj-Napoca, Cluj 400015
RomaniaSite Not Available
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1303)
Cluj-Napoca, Cluj 400015
RomaniaSite Not Available
SC Radiotherapy Center Cluj SRL ( Site 1307)
Comuna Floresti, Cluj 407280
RomaniaSite Not Available
Centrul de Oncologie Oncolab-Medical Oncology ( Site 1312)
Craiova, Dolj 200385
RomaniaSite Not Available
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1304)
Craiova, Dolj 200347
RomaniaSite Not Available
Spitalul Municipal Ploiesti ( Site 1308)
Ploiesti, Prahova 100337
RomaniaSite Not Available
Policlinica Oncomed SRL ( Site 1302)
Timisoara, Timis 300239
RomaniaSite Not Available
S.C.Focus Lab Plus S.R.L ( Site 1301)
Bucuresti, 022548
RomaniaSite Not Available
Spitalul Universitar de Urgenta Bucuresti ( Site 1305)
Bucuresti, 050098
RomaniaSite Not Available
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1407)
Saint-Petersburg, Sankt-Peterburg 197758
Russian FederationSite Not Available
SPBU Clinic of Advanced medical technologies n.a. N. I. Pirogov ( Site 1406)
Saint-Petersburg, Sankt-Peterburg 190103
Russian FederationSite Not Available
Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (o) ( Site 1424)
Saint-Petersburg, Sankt-Peterburg 197758
Russian FederationSite Not Available
Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1425)
Kazan, Tatarstan, Respublika 420029
Russian FederationSite Not Available
SPb SBHI City Clinical Oncological Dispensary ( Site 1409)
Sankt-Peterburg, 198255
Russian FederationSite Not Available
Wits Clinical Research ( Site 1510)
Johannesburg, Gauteng 2193
South AfricaSite Not Available
Marry Potter Oncology Centre ( Site 1502)
Pretoria, Gauteng 0181
South AfricaSite Not Available
Steve Biko Academic Hospital ( Site 1506)
Pretoria, Gauteng 0002
South AfricaSite Not Available
Sandton Oncology Medical Group PTY LTD ( Site 1505)
Sandton, Gauteng 2196
South AfricaSite Not Available
Chris Hani Baragwanath Academic Hospital-Wits Clinical Research Bara ( Site 1513)
Soweto, Gauteng 2013
South AfricaSite Not Available
The Oncology Centre ( Site 1507)
Durban, Limpopo 4001
South AfricaSite Not Available
Cape Town Oncology Trials Pty Ltd ( Site 1500)
Kraaifontein, Western Cape 7570
South AfricaSite Not Available
Hospital Insular de Gran Canaria-Oncology ( Site 1604)
Las Palmas de Gran Canaria, Las Palmas 35001
SpainSite Not Available
H.U. Vall de Hebron ( Site 1600)
Barcelona, 08035
SpainSite Not Available
Hospital Juan Ramon Jimenez ( Site 1602)
Huelva, 21005
SpainSite Not Available
Hospital Universitario Lucus Augusti ( Site 1603)
Lugo, 27003
SpainSite Not Available
Hospital Universitario La Paz ( Site 1601)
Madrid, 28046
SpainSite Not Available
Changhua Christian Hospital ( Site 2104)
Changhua, 50006
TaiwanSite Not Available
National Taiwan University Hospital Hsin-Chu Branch ( Site 2103)
Hsinchu, 300
TaiwanSite Not Available
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2107)
Kaohsiung, 807
TaiwanSite Not Available
National Cheng Kung University Hospital ( Site 2105)
Tainan, 704
TaiwanSite Not Available
National Taiwan University Hospital ( Site 2101)
Taipei, 10048
TaiwanSite Not Available
Taipei Veterans General Hospital ( Site 2106)
Taipei, 11217
TaiwanSite Not Available
Chang Gung Medical Foundation-Linkou Branch ( Site 2102)
Taoyuan, 333
TaiwanSite Not Available
Ankara Sehir Hastanesi ( Site 1702)
Ankara, 06800
TurkeySite Not Available
Gulhane Egitim ve Arastirma Hastanesi ( Site 1704)
Ankara, 06010
TurkeySite Not Available
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1701)
Istanbul, 34722
TurkeySite Not Available
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1703)
Izmir, 35040
TurkeySite Not Available
Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 1707)
Malatya, 44280
TurkeySite Not Available
Medical Center Mriya Med-Service ( Site 1805)
Kryvyi Rih, Dnipropetrovska Oblast 50000
UkraineSite Not Available
Communal non profit enterprise Regional Clinical Oncology Center ( Site 1806)
Kharkiv, Kharkivska Oblast 61070
UkraineSite Not Available
Ukrainian Center of Tomotherapy ( Site 1807)
Kropyvnytskyi, Kirovohradska Oblast 25011
UkraineSite Not Available
Medical Center Asklepion LLC ( Site 1804)
Khodosivka, Kyivska Oblast 08173
UkraineSite Not Available
Municipal non-profit enterprise'Odesa Regional Clinical Hosp-Thoracic surgery department. ( Site 181
Odesa, Odeska Oblast 65025
UkraineSite Not Available
Kremenchuk Regional Oncology Center ( Site 1811)
Kremenchuk, Poltavska Oblast 39617
UkraineSite Not Available
Kyiv City Clinical Oncology Centre ( Site 1809)
Kyiv, 03115
UkraineSite Not Available
Medical Center Dobrobut Clinic ( Site 1808)
Kyiv, 03151
UkraineSite Not Available
St. Bernards Medical Center ( Site 0103)
Jonesboro, Arkansas 72401
United StatesSite Not Available
St Joseph Heritage Healthcare-Oncology ( Site 0102)
Fullerton, California 92835
United StatesSite Not Available
Cancer Blood and Specialty Clinic ( Site 0105)
Los Alamitos, California 90720
United StatesSite Not Available
PIH Health Hematology Medical Oncology ( Site 0106)
Whittier, California 90602
United StatesSite Not Available
Holy Cross Hospital ( Site 0017)
Fort Lauderdale, Florida 33308
United StatesSite Not Available
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104)
Hollywood, Florida 33021
United StatesSite Not Available
Advent Health ( Site 0013)
Orlando, Florida 32804
United StatesSite Not Available
Fort Wayne Medical Oncology and Hematology ( Site 0101)
Fort Wayne, Indiana 46804
United StatesSite Not Available
Baptist Health Lexington ( Site 0099)
Lexington, Kentucky 40503
United StatesSite Not Available
St Luke's Hospital - Kansas City ( Site 0033)
Kansas City, Missouri 64111
United StatesSite Not Available
St. Vincent Frontier Cancer Center ( Site 0058)
Billings, Montana 59102
United StatesSite Not Available
Montefiore Medical Center [Bronx, NY] ( Site 0040)
Bronx, New York 10461
United StatesSite Not Available
The University of Tennessee Medical Center ( Site 0050)
Knoxville, Tennessee 37920
United StatesSite Not Available
Tennessee Oncology ( Site 0051)
Nashville, Tennessee 37203
United StatesSite Not Available
Millennium Physicians - Oncology ( Site 0097)
Houston, Texas 77090
United StatesSite Not Available
Oncology Consultants, PA ( Site 0052)
Houston, Texas 77030
United StatesSite Not Available
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100)
Blacksburg, Virginia 24060
United StatesSite Not Available
West Virginia University ( Site 0056)
Morgantown, West Virginia 26506
United StatesSite Not Available
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