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Sponsor: Merck Sharp & Dohme LLC
Conditions: Metastatic Non-small Cell Lung Cancer
Interventions: Pembrolizumab Formulated with Berahyaluronidase Alfa, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Countries: Japan
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Toyoake, Aichi-ken, Japan
- Kurume, Fukuoka, Japan
- Otashi, Gunma, Japan
- Sapporo, Hokkaido, Japan
- Yokohama, Kanagawa, Japan
- Natori-shi, Miyagi, Japan
- Sendai, Miyagi, Japan
- Kurashiki, Okayama-ken, Japan
- Hirakata, Osaka, Japan
- Takatsuki, Osaka, Japan
- Ina-machi, Saitama, Japan
- Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
- Utsunomiya, Tochigi, Japan
- Bunkyo-ku, Tokyo, Japan
- Fukuoka, Japan
- Fukuoka, Japan
- Osaka, Japan
- Tokyo, Japan