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A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension
Sponsor: Merck Sharp & Dohme LLC
Summary
This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab (+) berahyaluronidase alfa 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 pembrolizumab (+) berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2023-06-13
Completion Date
2028-05-22
Last Updated
2025-11-12
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.
Pemetrexed
Pemetrexed 500 mg/m² by IV Infusion will be administered for nonsquamous NSCLC as per the schedule specified in arm.
Cisplatin
Cisplatin 75 mg/m² by IV Infusion will be administered for nonsquamous and squamous NSCLC as per the schedule specified in arm.
Carboplatin
Carboplatin AUC 5 mg/mL/min in nonsquamous and AUC 6 mg/mL/min in squamous NSCLC will be administered as per the schedule specified in arm.
Paclitaxel
Paclitaxel 200 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.
Nab-paclitaxel
Nab-paclitaxel 100 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.
Pembrolizumab
Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.
Filgrastim
Filgrastim will be administered as per the schedule specified for the arm.
Pegylated filgrastim
Pegylated filgrastim will be administered as per the schedule specified for the arm.
Locations (18)
Fujita Health University ( Site 4406)
Toyoake, Aichi-ken, 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-shi, Miyagi, Japan
Sendai Kousei Hospital ( Site 4400)
Sendai, Miyagi, Japan
Kurashiki Central Hospital ( Site 4409)
Kurashiki, Okayama-ken, 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