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.
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.
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There are 108 Locations for this study
Phoenix Arizona, 85004, United States
Clermont Florida, 34711, United States
Orange City Florida, 32763, United States
Chicago Illinois, 60612, United States
Skokie Illinois, 60077, United States
Lafayette Indiana, 47905, United States
Paducah Kentucky, 42003, United States
Hattiesburg Mississippi, 39401, United States
Bolivar Missouri, 65613, United States
Ciudad Autónoma de Buenos Aires Buenos Aires, C1426, Argentina
Mar del Plata Buenos Aires, B7600, Argentina
ABB Caba, C1199, Argentina
Rosario Santa Fe, S2000, Argentina
Buenos Aires , C1122, Argentina
Caba , C1430, Argentina
Cordoba , 5000, Argentina
Fortaleza Ceara, 60336, Brazil
Recife Pernambuco, 50040, Brazil
Porto Alegre Rio Grande Do Sul, 91350, Brazil
Joinville Santa Catarina, 89201, Brazil
Sao Paulo , 01509, Brazil
La Serena Coquimbo, 17204, Chile
Valdivia Los Rios, 51121, Chile
Santiago Region M. De Santiago, 75009, Chile
Santiago Region M. De Santiago, 75100, Chile
Santiago Region M. De Santiago, 83300, Chile
Santiago Region M. De Santiago, 83804, Chile
Santiago Region M. De Santiago, 84203, Chile
Hefei Anhui, 23007, China
Beijing Beijing, 10014, China
Beijing Beijing, 10073, China
Beijing Beijing, 10114, China
Wanzhou Chongqing, 40419, China
Fuzhou Fujian, 35001, China
Guangzhou Guangdong, 51051, China
Jiangmen Guangdong, 52903, China
Shenzhen Guangdong, 51802, China
Wuhan Hubei, 43002, China
Nanchang Jiangxi, 33000, China
Xi'an Shaanxi, 71006, China
Shanghai Shanghai, 20003, China
Taiyuan Shanxi, 03000, China
Tianjin Tianjin, 30005, China
Hangzhou Zhejiang, 31000, China
Taizhou Zhejiang, 31700, China
Quimper Finistere, 29107, France
Tours Indre-et-Loire, 37044, France
Paris , 75014, France
Ciudad de Guatemala , 01010, Guatemala
Guatemala , 01016, Guatemala
Quetzaltenango , 09001, Guatemala
Quetzaltenango , 09002, Guatemala
Kecskemét Bacs-Kiskun, 6000, Hungary
Szolnok Jasz-Nagykun-Szolnok, 5000, Hungary
Törökbálint Pest, 2045, Hungary
Budapest , 1083, Hungary
Budapest , 1121, Hungary
Toyoake Aichi, 470-1, Japan
Kurume Fukuoka, 830-0, Japan
Otashi Gunma, 373-8, Japan
Sapporo Hokkaido, 003-0, Japan
Yokohama Kanagawa, 236-0, Japan
Natori Miyagi, 981-1, Japan
Sendai Miyagi, 98008, Japan
Kurashiki Okayama, 710-8, Japan
Hirakata Osaka, 573-1, Japan
Takatsuki Osaka, 569-8, Japan
Ina-machi Saitama, 362-0, Japan
Nagaizumi-cho,Sunto-gun Shizuoka, 411-8, Japan
Utsunomiya Tochigi, 320-0, Japan
Bunkyo-ku Tokyo, 11384, Japan
Fukuoka , 810-8, Japan
Fukuoka , 811-1, Japan
Osaka , 541-8, Japan
Tokyo , 113-8, Japan
Warszawa Mazowieckie, 02-78, Poland
Olsztyn Warminsko-mazurskie, 10-35, Poland
Koszalin Zachodniopomorskie, 75-58, Poland
Florești Cluj, 40728, Romania
Craiova Dolj, 20054, Romania
Timișoara Timis, 30023, Romania
Cluj , 40001, Romania
Port Elizabeth Eastern Cape, 6055, South Africa
Johannesburg Gauteng, 2196, South Africa
Pretoria Gauteng, 0001, South Africa
Sandton Gauteng, 2196, South Africa
Durban Kwazulu-Natal, 4091, South Africa
Cape Town Western Cape, 7570, South Africa
Santiago de Compostela La Coruna, 15706, Spain
Madrid Madrid, Comunidad De, 28009, Spain
Barcelona , 08035, Spain
Huelva , 21005, Spain
Changhua County Changhua, 50006, Taiwan
Kaohsiung Niao Sung Dist Kaohsiung, 83301, Taiwan
Taipei City Taipei, 106, Taiwan
Kaohsiung , 807, Taiwan
Kaohsiung , 82445, Taiwan
Tainan , 704, Taiwan
Taipei , 10002, Taiwan
Muang Chiang Mai, 50200, Thailand
Bangkok Krung Thep Maha Nakhon, 10330, Thailand
Siriraj Krung Thep Maha Nakhon, 10700, Thailand
Hatyai Songkhla, 90110, Thailand
Izmir, Karsiyaka Izmir, 00903, Turkey
Ankara , 06010, Turkey
Ankara , 06230, Turkey
Ankara , 06800, Turkey
Istanbul , 34722, Turkey
Kayseri , 38010, Turkey
Malatya , 44280, Turkey
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