Spots Global Cancer Trial Database for 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)-Japan Extension
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Trial Identification
Brief Title: 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)-Japan Extension
Official Title: 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
Study ID: NCT06212752
Conditions
Study Description
Brief 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 Japanese 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.
Detailed Description: Japan extension study will require approximately six years which includes one additional year (beyond the global study's last participant last study related contact) from the time the first participant (or their legally acceptable representative) provides informed consent until the last participant's last study related contact to complete. The Japan extension study will include participants previously enrolled in Japan in the global study for MK-3475A-D77 (NCT05722015) plus the study will continue to enroll participants in Japan until the sample size for participants in Japan reaches approximately 39.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fujita Health University ( Site 4406), Toyoake, Aichi, Japan
Kurume University Hospital ( Site 4412), Kurume, Fukuoka, Japan
Gunma Prefectural Cancer Center ( Site 4416), Otashi, Gunma, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 4415), Sapporo, Hokkaido, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 4404), Yokohama, Kanagawa, Japan
Miyagi Cancer Center ( Site 4401), Natori, Miyagi, Japan
Sendai Kousei Hospital ( Site 4400), Sendai, Miyagi, Japan
Kurashiki Central Hospital ( Site 4409), Kurashiki, Okayama, Japan
Kansai Medical University Hospital ( Site 4408), Hirakata, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 4414), Takatsuki, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 4402), Ina-machi, Saitama, Japan
Shizuoka Cancer Center ( Site 4405), Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
Tochigi Cancer Center ( Site 4417), Utsunomiya, Tochigi, Japan
Juntendo University Hospital ( Site 4413), Bunkyo-ku, Tokyo, Japan
National Hospital Organization Kyushu Medical Center ( Site 4411), Fukuoka, , Japan
National Hospital Organization Kyushu Cancer Center ( Site 4410), Fukuoka, , Japan
Osaka International Cancer Institute ( Site 4407), Osaka, , Japan
Nippon Medical School Hospital ( Site 4403), Tokyo, , Japan
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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