Lung Cancer Clinical Trial

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

Summary

This study is to assess the pharmacokinetics (PK) and safety of SC MK-3475A vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are MK-3475A subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

View Eligibility Criteria

Eligibility Criteria

The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC).
Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated.
Has a life expectancy of at least 3 months.

Exclusion Criteria:

Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
Has received prior systemic anticancer therapy for metastatic NSCLC.
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids.
Has received radiation therapy to the lung (>30 Gray) within 6 months of start of study intervention.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has an active infection requiring systemic therapy.
Has a history of human immunodeficiency virus (HIV) infection.
Has a history of Hepatitis B or C.
Has not adequately recovered from major surgery or has ongoing surgical complications.
Has a history of allogenic tissue/solid organ transplant.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

339

Study ID:

NCT05722015

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 108 Locations for this study

See Locations Near You

St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023)
Phoenix Arizona, 85004, United States
Clermont Oncology Center ( Site 0018)
Clermont Florida, 34711, United States
Mid Florida Hematology and Oncology Center ( Site 0010)
Orange City Florida, 32763, United States
University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022)
Chicago Illinois, 60612, United States
Orchard Healthcare Research Inc. ( Site 0011)
Skokie Illinois, 60077, United States
Franciscan Health Lafayette East ( Site 0020)
Lafayette Indiana, 47905, United States
Mercy Health-Paducah Medical Oncology and Hematology ( Site 0006)
Paducah Kentucky, 42003, United States
Hattiesburg Clinic Hematology/Oncology ( Site 0008)
Hattiesburg Mississippi, 39401, United States
Central Care Cancer Center - Bolivar ( Site 0017)
Bolivar Missouri, 65613, United States
Instituto Alexander Fleming ( Site 1008)
Ciudad Autónoma de Buenos Aires Buenos Aires, C1426, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)
Mar del Plata Buenos Aires, B7600, Argentina
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005)
ABB Caba, C1199, Argentina
Sanatorio Parque ( Site 1003)
Rosario Santa Fe, S2000, Argentina
Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002)
Buenos Aires , C1122, Argentina
Clinica Adventista Belgrano-Oncology ( Site 1004)
Caba , C1430, Argentina
Hospital Italiano de Córdoba ( Site 1000)
Cordoba , 5000, Argentina
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102)
Fortaleza Ceara, 60336, Brazil
Hospital de Câncer de Recife ( Site 1107)
Recife Pernambuco, 50040, Brazil
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100)
Porto Alegre Rio Grande Do Sul, 91350, Brazil
Instituto Joinvilense de Hematologia e Oncologia ( Site 1101)
Joinville Santa Catarina, 89201, Brazil
A. C. Camargo Cancer Center ( Site 1106)
Sao Paulo , 01509, Brazil
IC La Serena Research ( Site 1207)
La Serena Coquimbo, 17204, Chile
Oncocentro Valdivia ( Site 1201)
Valdivia Los Rios, 51121, Chile
FALP-UIDO ( Site 1203)
Santiago Region M. De Santiago, 75009, Chile
Oncovida ( Site 1209)
Santiago Region M. De Santiago, 75100, Chile
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210)
Santiago Region M. De Santiago, 83300, Chile
Instituto Nacional del Cancer-CR Investigación ( Site 1211)
Santiago Region M. De Santiago, 83804, Chile
Bradfordhill-Clinical Area ( Site 1202)
Santiago Region M. De Santiago, 84203, Chile
Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503)
Hefei Anhui, 23007, China
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510)
Beijing Beijing, 10014, China
Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501)
Beijing Beijing, 10073, China
Beijing Chest Hospital,Capital Medical University ( Site 4511)
Beijing Beijing, 10114, China
Chongqing Three Gorges Central Hospital ( Site 4516)
Wanzhou Chongqing, 40419, China
Fujian Provincial Cancer Hospital ( Site 4517)
Fuzhou Fujian, 35001, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
Guangzhou Guangdong, 51051, China
Jiangmen Center Hospital ( Site 4509)
Jiangmen Guangdong, 52903, China
ShenZhen People's Hospital ( Site 4504)
Shenzhen Guangdong, 51802, China
Wuhan Union Hospital Cancer Center-Cancer center ( Site 4502)
Wuhan Hubei, 43002, China
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515)
Nanchang Jiangxi, 33000, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520)
Xi'an Shaanxi, 71006, China
Fudan University Shanghai Cancer Center-Oncology ( Site 4512)
Shanghai Shanghai, 20003, China
Shanxi Cancer Hospital ( Site 4521)
Taiyuan Shanxi, 03000, China
Tianjin Chest Hospital ( Site 4518)
Tianjin Tianjin, 30005, China
The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514)
Hangzhou Zhejiang, 31000, China
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 4508)
Taizhou Zhejiang, 31700, China
Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600)
Quimper Finistere, 29107, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602)
Tours Indre-et-Loire, 37044, France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603)
Paris , 75014, France
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404)
Ciudad de Guatemala , 01010, Guatemala
MEDI-K CAYALA ( Site 1403)
Guatemala , 01016, Guatemala
Centro Regional de Sub Especialidades Médicas SA ( Site 1401)
Quetzaltenango , 09001, Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 1400)
Quetzaltenango , 09002, Guatemala
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102)
Kecskemét Bacs-Kiskun, 6000, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103)
Szolnok Jasz-Nagykun-Szolnok, 5000, Hungary
Törökbálinti Tüdőgyógyintézet ( Site 2105)
Törökbálint Pest, 2045, Hungary
Semmelweis Egyetem-Pulmonológiai Klinika ( Site 2104)
Budapest , 1083, Hungary
Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100)
Budapest , 1121, Hungary
Fujita Health University ( Site 4406)
Toyoake Aichi, 470-1, Japan
Kurume University Hospital ( Site 4412)
Kurume Fukuoka, 830-0, Japan
Gunma Prefectural Cancer Center ( Site 4416)
Otashi Gunma, 373-8, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 4415)
Sapporo Hokkaido, 003-0, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 4404)
Yokohama Kanagawa, 236-0, Japan
Miyagi Cancer Center ( Site 4401)
Natori Miyagi, 981-1, Japan
Sendai Kousei Hospital ( Site 4400)
Sendai Miyagi, 98008, Japan
Kurashiki Central Hospital ( Site 4409)
Kurashiki Okayama, 710-8, Japan
Kansai Medical University Hospital ( Site 4408)
Hirakata Osaka, 573-1, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 4414)
Takatsuki Osaka, 569-8, Japan
Saitama Prefectural Cancer Center ( Site 4402)
Ina-machi Saitama, 362-0, Japan
Shizuoka Cancer Center ( Site 4405)
Nagaizumi-cho,Sunto-gun Shizuoka, 411-8, Japan
Tochigi Cancer Center ( Site 4417)
Utsunomiya Tochigi, 320-0, Japan
Juntendo University Hospital ( Site 4413)
Bunkyo-ku Tokyo, 11384, Japan
National Hospital Organization Kyushu Medical Center ( Site 4411)
Fukuoka , 810-8, Japan
National Hospital Organization Kyushu Cancer Center ( Site 4410)
Fukuoka , 811-1, Japan
Osaka International Cancer Institute ( Site 4407)
Osaka , 541-8, Japan
Nippon Medical School Hospital ( Site 4403)
Tokyo , 113-8, Japan
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Warszawa Mazowieckie, 02-78, Poland
Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii
Olsztyn Warminsko-mazurskie, 10-35, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801)
Koszalin Zachodniopomorskie, 75-58, Poland
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303)
Florești Cluj, 40728, Romania
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2301)
Craiova Dolj, 20054, Romania
Cabinet Medical Oncomed ( Site 2305)
Timișoara Timis, 30023, Romania
Institutul Oncologic-Oncologie Medicala ( Site 2302)
Cluj , 40001, Romania
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903)
Port Elizabeth Eastern Cape, 6055, South Africa
Medical Oncology Centre of Rosebank ( Site 2907)
Johannesburg Gauteng, 2196, South Africa
Steve Biko Academic Hospital-Medical Oncology ( Site 2904)
Pretoria Gauteng, 0001, South Africa
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900)
Sandton Gauteng, 2196, South Africa
The Oncology Centre ( Site 2901)
Durban Kwazulu-Natal, 4091, South Africa
Cape Town Oncology Trials ( Site 2902)
Cape Town Western Cape, 7570, South Africa
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404)
Santiago de Compostela La Coruna, 15706, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401)
Madrid Madrid, Comunidad De, 28009, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 2400)
Barcelona , 08035, Spain
Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402)
Huelva , 21005, Spain
Changhua Christian Hospital ( Site 4203)
Changhua County Changhua, 50006, Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 4200)
Kaohsiung Niao Sung Dist Kaohsiung, 83301, Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 4205)
Taipei City Taipei, 106, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207)
Kaohsiung , 807, Taiwan
E-Da hospital ( Site 4208)
Kaohsiung , 82445, Taiwan
National Cheng Kung University Hospital ( Site 4202)
Tainan , 704, Taiwan
National Taiwan University Hospital-Oncology ( Site 4204)
Taipei , 10002, Taiwan
Maharaj Nakorn Chiang Mai Hospital ( Site 4300)
Muang Chiang Mai, 50200, Thailand
Chulalongkorn University ( Site 4301)
Bangkok Krung Thep Maha Nakhon, 10330, Thailand
Division of Medical Oncology, Siriraj H ( Site 4303)
Siriraj Krung Thep Maha Nakhon, 10700, Thailand
Songklanagarind hospital ( Site 4302)
Hatyai Songkhla, 90110, Thailand
I.E.U. Medical Point Hastanesi-Oncology ( Site 2507)
Izmir, Karsiyaka Izmir, 00903, Turkey
Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504)
Ankara , 06010, Turkey
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506)
Ankara , 06230, Turkey
Ankara City Hospital-Medical Oncology ( Site 2501)
Ankara , 06800, Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
Istanbul , 34722, Turkey
Memorial Kayseri Hastanesi ( Site 2500)
Kayseri , 38010, Turkey
İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503)
Malatya , 44280, Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

339

Study ID:

NCT05722015

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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