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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: United States, Argentina, Brazil, Chile, China, France, Guatemala, Hungary
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.
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
- Phoenix, Arizona, United States
- Clermont, Florida, United States
- Orange City, Florida, United States
- Chicago, Illinois, United States
- Skokie, Illinois, United States
- Lafayette, Indiana, United States
- Paducah, Kentucky, United States
- Hattiesburg, Mississippi, United States
- Bolivar, Missouri, United States
- Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Buenos Aires, Buenos Aires F.D., Argentina
- Buenos Aires, Buenos Aires F.D., Argentina
- Buenos Aires, Buenos Aires F.D., Argentina
- Rosario, Santa Fe Province, Argentina
- Córdoba, Argentina
- Fortaleza, Ceará, Brazil
- Recife, Pernambuco, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Joinville, Santa Catarina, Brazil
- São Paulo, Brazil
- La Serena, Coquimbo Region, Chile
- Valdivia, Los Ríos Region, Chile
- Santiago, Region M. de Santiago, Chile
- Santiago, Region M. de Santiago, Chile
- Santiago, Region M. de Santiago, Chile
- Santiago, Region M. de Santiago, Chile
- Santiago, Region M. de Santiago, Chile
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- + 80 more on CT.gov