A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer
A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer
This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
Phoenix, Arizona 85004, United States
Chicago, Illinois 60612, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires C1199ABB, Argentina
Mar del Plata, Buenos Aires B7600FZO, Argentina
Buenos Aires, Buenos Aires F.D. C1122AAL, Argentina
Buenos Aires, Buenos Aires F.D. C1430EGF, Argentina
Fortaleza, Ceará 60336-232, Brazil
Porto Alegre, Rio Grande do Sul 91350-200, Brazil
Joinville, Santa Catarina 89201-260, Brazil
Santiago, Region M. de Santiago 8330024, Chile
Santiago, Region M. de Santiago 8380455, Chile
Beijing, Beijing Municipality 100142, China
Beijing, Beijing Municipality 100730, China
Beijing, Beijing Municipality 101149, China
Wanzhou, Chongqing Municipality 404199, China
Guangzhou, Guangdong 510515, China
Wuhan, Hubei 430048, China
Nanchang, Jiangxi 330006, China
Shanghai, Shanghai Municipality 200032, China
Hangzhou, Zhejiang 310003, China
Tours, Indre-et-Loire 37000, France
Kecskemét, Bács-Kiskun county 6000, Hungary
Szolnok, Jász-Nagykun-Szolnok 5004, Hungary
Budapest, 1121, Hungary
Kitaadachi-gun, Saitama 362-0806, Japan
Sunto-gun,, Shizuoka 411-8777, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Warsaw, Masovian Voivodeship 02-781, Poland
Olsztyn, Warmian-Masurian Voivodeship 10-357, Poland
Koszalin, West Pomeranian Voivodeship 75-581, Poland
Florești, Cluj 407280, Romania
Port Elizabeth, Eastern Cape 6055, South Africa
Santiago de Compostela, La Coruna 15706, Spain
Madrid, Madrid, Comunidad de 28009, Spain
Taipei City, Taipei 106, Taiwan
Istanbul, 34722, Turkey (Türkiye)