Lung Cancer, Non-Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
BIOLOGICALPembrolizumab (+) Berahyaluronidase alfa
Administered subcutaneously on Day 1 of each cycle
BIOLOGICALPembrolizumab
Administered intravenously on Day 1 of each cycle
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC). * Measurable disease as assessed by the local site investigator/radiology.
Exclusion criteria
* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. * Received prior systemic anticancer therapy for their metastatic NSCLC. * Known additional malignancy that is progressing or has required active treatment within the past 3 years. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Active autoimmune disease that has required systemic treatment in the past 2 years. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Active infection requiring systemic therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose | At designated time points (up to approximately 14 months) | 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. |
| Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State | At designated time points (Up to ~15 months) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an AE- All Participants | Up to approximately 28 months | 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. |
| Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 25 months | 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. |
Countries
China, Germany, Guatemala, Japan, Peru, Poland, Romania, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp and Dohme LLC
Outcome results
None listed