Phase
Condition
N/ATreatment
Cisplatin
Placebo
Paclitaxel
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous)that is Stage IV (AJCC v8).
No prior systemic treatment for the advanced/metastatic NSCLC
Able to provide a formalin-fixed archival tumor tissue sample during screening, or afresh tumor biopsy
Measurable disease per RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of at least 3 months.
Willingness to avoid pregnancy or fathering children.
Adequate organ function as indicated by protocol-specified laboratory values. - Hasbeen fully vaccinated against SARS-CoV-2 or is willing and able to be fullyvaccinated against SARS-CoV-2 during the study by starting the vaccination processduring screening.
Exclusion
Exclusion Criteria:
Clinically significant cardiac disease within 6 months of start of study treatment.
Any major surgery within 3 weeks of the first dose of study treatment.
Thoracic radiation therapy of > 30 Gy within 6 months of the first dose of studytreatment.
History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receivecisplatin, paclitaxel, or nab-paclitaxel.
Untreated central nervous system metastases and/or carcinomatous meningitis.
Evidence or history of interstitial lung disease or noninfectious pneumonitis thatrequired systemic steroids.
Active infection requiring systemic therapy or active tuberculosis. Note: Ifrequired by country or local regulations to be tested for COVID-19 during screening,a participant should be excluded if they have a positive test result for SARS CoV-2infection until both the retesting result is negative and clinical recovery isobtained.
Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervicalcancer, or other in situ cancers.
Has contraindications to chemotherapy agents used in the study.
Has an active autoimmune disease that has required systemic treatment in past 2years.
Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the firstdose of study treatment.
Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug).
Note: While based on approved SARS-CoV-2 vaccines available worldwide, many vaccines are not live (mRNA and adenovirus vaccines do not contain live virus), if a live vaccine against SARS-CoV-2 is the only available option, prior consultation with the medical monitor should be obtained.
• Has known active HBV or HCV (testing must be performed to determine eligibility)
Study Design
Connect with a study center
Instituto de Investigaciones Metabolicas (Idim)
Ciudad Autonoma Buenos Aires, C1012AAR
ArgentinaSite Not Available
Hospital Privado Centro Medico de Cordoba S.A
Cordoba, 05016
ArgentinaSite Not Available
Sanatorio Parque S.A.
Rosario, S2000DSV
ArgentinaSite Not Available
Cer San Juan Centro Polivalente de Asistencia E Inv. Clinica
San Juan, 05400
ArgentinaSite Not Available
Centro Medico San Roque S.R.L.
San Miguel de Tucuman, 04000
ArgentinaSite Not Available
Clinicas Viedma S.A.
Viedma, R8500ACE
ArgentinaSite Not Available
Fundacao Pio Xii Hospital de Cancer de Barretos
Barretos, 14784-400
BrazilSite Not Available
Incan - Instituto Do Cancer - Hospital Pompeia
Caxias Do Sul, 95010-005
BrazilSite Not Available
Centro Regional Integrado de Oncologia
Fortaleza, 60336-045
BrazilSite Not Available
Oncosite - Centro de Pesquisa Clinica E Oncologia
IJU, 98700-000
BrazilSite Not Available
Oncosite - Centro de Pesquisa Clinica E Oncologia
Ijua, 98700-000
BrazilSite Not Available
Oncosite - Centro de Pesquisa Clinica E Oncologia
Ijui, 98700-000
BrazilSite Not Available
Clinica de Neoplasias Litoral Ltda
Itaja, 88301-220
BrazilSite Not Available
Clinica de Neoplasias Litoral Ltda
Itajai, 88301-220
BrazilSite Not Available
Clinica de Neoplasias Litoral Ltda
Itajaí, 88301-220
BrazilSite Not Available
Hospital Do Cancer de Londrina
Londrina, 86015-520
BrazilSite Not Available
Instituto Mederi de Pesquisa E Saude
Passo Fundo, 99010-120
BrazilSite Not Available
Hgb - Hospital Giovanni Battista - Mae de Deus Center
Porto Alegre, 90470-340
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Rio Preto, 5524
BrazilSite Not Available
Inca - Instituto Nacional de Cancer
Rio de Janeiro, 20230-130
BrazilSite Not Available
Sao Camilo Oncologia
S?O Paulo, 03102-002
BrazilSite Not Available
Ibcc - Instituto Brasileiro de Controle Do Cancer
San Paulo, 03102-002
BrazilSite Not Available
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo ANDR, 09060-870
BrazilSite Not Available
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo Andra, 09060-870
BrazilSite Not Available
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo Andre, 09060-870
BrazilSite Not Available
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, 09060-870
BrazilSite Not Available
A. C. Camargo Cancer Center
Santo Paulo, 01509-900
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose, 15090-000
BrazilSite Not Available
Sao Camilo Oncologia
Sao Paulo, 03102-002
BrazilSite Not Available
Sao Camilo Oncologia
São Paulo, 03102-002
BrazilSite Not Available
Sao Camilo Oncologia
S�O Paulo, 03102-002
BrazilSite Not Available
Acibadem Cityclinica Mhat Tokuda
Sofia, 01407
BulgariaSite Not Available
Mc Women'S Health-Nadezhda Eood
Sofia, 01330
BulgariaSite Not Available
Mhat Serdika Eood
Sofia, 01632
BulgariaSite Not Available
Multiprofile Hospital For Active Treatment Central Onco Hospital Ood
Sofia, 01797
BulgariaSite Not Available
Umhat Sv. Ivan Rilski Ead
Sofia, 01431
BulgariaSite Not Available
Shatod Dr Marko Marko - Varna Ltd
Varna, 09002
BulgariaSite Not Available
Hunan Cancer Hospital
Changsha, 410013
ChinaSite Not Available
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou, 510080
ChinaSite Not Available
Hangzhou Cancer Hospital
Hangzhou, 310002
ChinaSite Not Available
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310001
ChinaSite Not Available
The First Affiliated Hospital of Zhejiang University
Hangzhou, 310003
ChinaSite Not Available
Zhejiang Cancer Hospital
Hangzhou, 310022
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Harbin, 150081
ChinaSite Not Available
The Second Hospital of Anhui Medical University
Hefei, 230601
ChinaSite Not Available
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
Hefei, 230001
ChinaSite Not Available
Jinan Central Hospital
Jinan, 250013
ChinaSite Not Available
Linyi Cancer Hospital
Linyi, 276001
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Nanchang, 330006
ChinaSite Not Available
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021
ChinaSite Not Available
Shanghai Chest Hospital
Shanghai, 200030
ChinaSite Not Available
General Hospital of Tianjin
Tianjing, 300052
ChinaSite Not Available
The Affiliated Cancer Hospital of Xinjiang Medical University
Urumqi, 830000
ChinaSite Not Available
Henan Cancer Hostipal
Zhengzhou, 450003
ChinaSite Not Available
Henan Provincial Peoples Hospital
Zhengzhou, 450003
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
ChinaSite Not Available
University Hospital Hradec Kralove
Hradec Kralove, 50333
CzechiaSite Not Available
Fakultni Nemocnice Olomouc
Olomouc, 775 20
CzechiaSite Not Available
Nemocnice Agel Ostrava - Vitkovice A.S
Ostrava - Vitkovice, 703 84
CzechiaSite Not Available
Fakultni Nemocnice V Motole
Praha 5, 150 06
CzechiaSite Not Available
High Technology Hospital Medcenter
Batumi, 06000
GeorgiaSite Not Available
Jsc Evex Hospitals
Kutaisi, 04600
GeorgiaSite Not Available
Archangel St. Michael Multi Profile Clinical Hospital
Tbilisi, 00102
GeorgiaSite Not Available
Cancer Research Center Ltd
Tbilisi, 00177
GeorgiaSite Not Available
HIGH TECHNOLOGY MEDICAL�CENTER, UNIVERSITY CLINIC
Tbilisi, 00144
GeorgiaActive - Recruiting
High Technology Medical Center, University Clinic
Tbilisi, 00144
GeorgiaSite Not Available
Institute of Clinical Oncology Ltd
Tbilisi, 00159
GeorgiaSite Not Available
Israel-Georgian Medical Research Clinic Helsicore
Tbilisi, 00112
GeorgiaSite Not Available
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, 00141
GeorgiaSite Not Available
New Hospitals
Tbilisi, 00114
GeorgiaSite Not Available
Tbilisi State Medical University First University Clinic
Tbilisi, 00141
GeorgiaSite Not Available
Orszagos Koranyi Tbc Es Pulmonological Intezet
Budapest, 01121
HungarySite Not Available
Bacs Kiskun Megyei Oktatokorhaz
Kecskemet, 06000
HungarySite Not Available
Advanced Medical and Dental Institute Husm
Kepala Batas, 13200
MalaysiaSite Not Available
University Malaya Medical Centre
Kuala Lumpur, 59100
MalaysiaSite Not Available
Hospital Tengku Ampuan Afzan
Kuantan, 25100
MalaysiaSite Not Available
Sarawak General Hospital
Kuching, 93586
MalaysiaSite Not Available
Beacon Hospital Sdn Bhd
Petaling Jaya, 46050
MalaysiaSite Not Available
Hospital Pulau Pinang
Pulau Pinang, 10990
MalaysiaSite Not Available
Institut Kanser Negara - National Cancer Institute
Putrajaya, 62250
MalaysiaSite Not Available
Centro Oncologico de Chihuahua (Coc)
Chihuahua, 31217
MexicoSite Not Available
Investigacion Onco Farmaceutica S. de R.L. de C.V. (Oncotech)
La Paz, 23040
MexicoSite Not Available
Coi Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico, 04700
MexicoSite Not Available
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03810
MexicoSite Not Available
Axis Heilsa S. de R.L. de C.V.
Monterrey, 64060
MexicoSite Not Available
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, 64460
MexicoSite Not Available
Clinical Medical Research S.C.
Orizaba, 94300
MexicoSite Not Available
Oncologico Potosino
SAN LUIS Potos, 78250
MexicoSite Not Available
Oncologico Potosino
San Luis, 78250
MexicoSite Not Available
Oncologico Potosino
San Luis Potosi, 78250
MexicoSite Not Available
Oncologico Potosino
San Luis Potosí, 78250
MexicoSite Not Available
Cebu Doctors University Hospital
Cebu City, 06000
PhilippinesSite Not Available
Davao Doctors Hospital
Davao City, 08000
PhilippinesSite Not Available
West Visayas State University Medical Center
Iloilo City, 05000
PhilippinesSite Not Available
Makati Medical Center
Makati, 01229
PhilippinesSite Not Available
Makati Medical Center
Makati City, 01229
PhilippinesSite Not Available
Philippine General Hospital
Manila, 01000
PhilippinesSite Not Available
Asian Hospital and Medical Center
Muntinlupa, 01781
PhilippinesSite Not Available
The Medical City
Pasig City, 01605
PhilippinesSite Not Available
St. Lukes Medical Center
Quezon City, 01102
PhilippinesSite Not Available
Ko-Med Centra Kliniczne Biala Podlaska
Biala Podlaska, 21-500
PolandSite Not Available
Centrum Medyczne Plejady
KRAK�W, 30-363
PolandSite Not Available
Przychodnia Lekarska Komed
Konin, 62-500
PolandSite Not Available
Centrum Medyczne Plejady
Krakow, 30-363
PolandSite Not Available
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
Lodz, 90-242
PolandSite Not Available
Przychodnia Med-Polonia Sp. Z O.O.
Poznan, 60-693
PolandSite Not Available
S.C Oncopremium Team S.R.L
Baia Mare, 430295
RomaniaSite Not Available
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj Napoca, 400015
RomaniaSite Not Available
Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
Cluj-napoca, 400132
RomaniaSite Not Available
Spitalul Clinic Judetean de Urgenta Constanta
Constanta, 900591
RomaniaSite Not Available
Oncomed Srl
Timisoara, 300239
RomaniaSite Not Available
S C Oncocenter Oncologie Medicala S R L
Timisoara, 300166
RomaniaSite Not Available
Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, 163045
Russian FederationSite Not Available
Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee
Kursk, 305035
Russian FederationSite Not Available
Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams
Moscow, 121309
Russian FederationSite Not Available
Llc Tonus
Nizniy Novgorod, 603089
Russian FederationSite Not Available
Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary
Novosibirsk, 630108
Russian FederationSite Not Available
Bhi of Omsk Region Clinical Oncology Dispensary
Omsk, 644013
Russian FederationSite Not Available
N.N. Petrov Research Institute of Oncology
Pos.pesochnyi, 197758
Russian FederationSite Not Available
N.N. Petrov Research Institute of Oncology
Saint-petersburg, 197758
Russian FederationSite Not Available
Pavlov First Saint Petersburg State Medical University
Saint-petersburg, 197022
Russian FederationSite Not Available
N.N. Petrov Research Institute of Oncology
St Petersburg, 197758
Russian FederationSite Not Available
Sbhi Volgograd Regional Onclogy Dispensary
Volgograd, 400138
Russian FederationSite Not Available
Oncomed-System
Belgrad, 11000
SerbiaSite Not Available
Clinical Center Bezanijska Kosa
Belgrade, 11000
SerbiaSite Not Available
Clinical Center of Serbia
Belgrade, 11 000
SerbiaSite Not Available
Oncomed-System
Beograd, 11000
SerbiaSite Not Available
Clinical Center Kragujevac
Kragujevac, 34000
SerbiaSite Not Available
Institute For Pulmonary Diseases of Vojvodina
Sremska Kamenica, 21204
SerbiaSite Not Available
Cancercare Rondebosch Oncology Centre
Cape Town, 07700
South AfricaSite Not Available
Cape Town Oncology Trials (Pty) Ltd
Cape Town, 07570
South AfricaSite Not Available
Sandton Oncology Centre
Johannesburg, 02196
South AfricaSite Not Available
Wits Clinical Research
Johannesburg, 02193
South AfricaSite Not Available
Mary Potter Oncology Centre
Pretoria, 00181
South AfricaSite Not Available
University of Pretoria Oncology Department
Pretoria, 00002
South AfricaSite Not Available
Acibadem Adana Hospital
Adana, 01130
TurkeySite Not Available
Adana Sehir Hastanesi
Adana, 01230
TurkeySite Not Available
Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
Ankara, 06105
TurkeySite Not Available
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100
TurkeySite Not Available
Memorial Ankara Hospital
Ankara, 06520
TurkeySite Not Available
Yildirim Beyazit University Ankara Ataturk Training and Research Hospital
Ankara, 06800
TurkeySite Not Available
Memorial Antalya Hastanesi
Antalya, 07020
TurkeySite Not Available
Trakya Universitesi Tip Fakultesi
Edirne, 22030
TurkeySite Not Available
Gaziantep University Gaziantep Oncology Hospital
Gaziantep, 27310
TurkeySite Not Available
Bakirkoy Dr Sadi Konuk Teaching and Research Hospital
Istanbul, 34147
TurkeySite Not Available
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul, 34098
TurkeySite Not Available
Medipol University Medical Faculty
Istanbul, 34214
TurkeySite Not Available
Izmir Medicalpark Hospital
Izmir, 35530
TurkeySite Not Available
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
Konya, 42080
TurkeySite Not Available
Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya, 44280
TurkeySite Not Available
Multifield Clinical Hospital No 4
Dnipro, 49102
UkraineSite Not Available
Ci Carpathian Clinical Oncological Center
Ivano-frankivsk, 76018
UkraineSite Not Available
Communal Non-Profit Enterprise Regional Center of Oncology
Kharkiv, 61070
UkraineSite Not Available
V.T.Zaycev Institute of General and Urgent Surgery of National Academy Medical Sciences of Ukraine
Kharkiv, 61103
UkraineSite Not Available
Kherson Regional Oncologic Dispensary
Kherson, 73000
UkraineSite Not Available
Pp Ppc Acinus Medical and Diagnostic Centre
Kropyvnytskyi, 25006
UkraineSite Not Available
Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
Kryvyi Rih, 50048
UkraineSite Not Available
Ci of Krc Kyiv Regional Oncologic Dispensary
Kyiv, 04107
UkraineSite Not Available
Kyiv City Clinical Oncological Center
Kyiv, 03115
UkraineSite Not Available
Medical Center Asklepion Llc
Kyiv, 03126
UkraineSite Not Available
Volyn Regional Oncological Dispensary
Lutsk, 43018
UkraineSite Not Available
Rmi Sumy Regional Clinical Oncology Dispensary
Sumy, 40022
UkraineSite Not Available
Cne Ccch of Uzh Cc Oncological Center
Uzhgorod, 88000
UkraineSite Not Available
Medical Center Oncolife Llc
Zaporizhzhia, 69059
UkraineSite Not Available
Pacific Cancer Medical Center
Anaheim, California 92801
United StatesSite Not Available
Innovative Clinical Research Institute
Whittier, California 90603
United StatesSite Not Available
Reading Hospital and Medical Center
Reading, Pennsylvania 19612
United StatesSite Not Available
Can Tho Oncology Hospital
Can Tho, 00000
VietnamSite Not Available
103 Military Hospital
Hanoi, 00000
VietnamSite Not Available
Bach Mai Hospital
Hanoi, 100000
VietnamSite Not Available
Hanoi Oncology Hospital
Hanoi, 100000
VietnamSite Not Available
National Cancer Hospital
Hanoi, 100000
VietnamSite Not Available
National Lung Hospital
Hanoi, 10000
VietnamSite Not Available
Hcmc Oncology Hospital
Ho Chi Minh City, 722681
VietnamSite Not Available
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