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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 (+) 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.
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. As of Amendment 1 of the supplemental statistical analysis plan (effective date: 23 Aug 2024), patient reported outcomes will no longer be the secondary outcome measures of the study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 13, 2023
Primary Completion Date
November 6, 2024
Completion Date
May 22, 2028
Last Updated
November 12, 2025
39
ACTUAL participants
Pembrolizumab (+) Berahyaluronidase alfa
BIOLOGICAL
Pemetrexed
DRUG
Cisplatin
DRUG
Carboplatin
DRUG
Paclitaxel
DRUG
Nab-paclitaxel
DRUG
Pembrolizumab
BIOLOGICAL
Filgrastim
DRUG
Pegylated filgrastim
DRUG
Lead Sponsor
Merck Sharp & Dohme LLC
NCT06975293
NCT06343402
Data Source & Attribution
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