Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body. Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to learn what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Administered subcutaneously on Day 1 of each cycle
Administered intravenously on Day 1 of each cycle
Providence Medical Foundation ( Site 0117)
Fullerton, California, United States
Illinois Cancer Care ( Site 0101)
Peoria, Illinois, United States
Montefiore Medical Center ( Site 0104)
The Bronx, New York, United States
University of Cincinnati Medical Center ( Site 0112)
Cincinnati, Ohio, United States
Beijing Peking Union Medical College Hospital ( Site 5000)
Beijing, Beijing Municipality, China
Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
AUC is defined as area under curve exposure. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Time frame: At designated time points (up to approximately 14 months)
Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough
Time frame: At designated time points (Up to ~15 months)
Number of Participants Who Experience an AE- All Participants
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 28 months
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 25 months
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Chongqing University Three Gorges Hospital ( Site 5018)
Chongqing, Chongqing Municipality, China
Fujian Province Cancer Hospital ( Site 5007)
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University ( Site 5008)
Xiamen, Fujian, China
The first affiliated hospital, Sun Yat-Sen university ( Site 5011)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 5003)
Guangzhou, Guangdong, China
...and 57 more locations